Multicare Clinics Jobs in Usa
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Position Title: Contract Clinical Operations Lead (cCOL)
Location: South San Francisco, CA 94080
Duration: 12-Month
Arrangement: Hybrid – 3 days onsite / 2 days remote
Position Overview
Our organization is driven by a bold vision to deliver 3–5x more patient benefit at 50% less cost to society. Within Pharma Product Development (PD) Global, we are transforming how clinical trials are designed and delivered to improve the experience for patients, caregivers, and research sites.
We are seeking a Contract Clinical Operations Lead (cCOL) to join our Global Clinical Operations community. This role will support the operational execution of clinical studies across disease areas while collaborating with cross-functional teams to improve clinical trial delivery and drive innovation in clinical development.
Key Responsibilities
- Contribute to clinical trial operational activities that support the execution and delivery of clinical studies within the PD portfolio.
- Provide operational and strategic input to cross-functional study teams across multiple disease areas.
- Support local and global initiatives aligned with clinical development priorities.
- Ensure quality, compliance, and data integrity, maintaining adherence to GCP/GVP standards and regulatory requirements.
- Collaborate with internal stakeholders to support clinical trial planning, execution, and operational improvements.
- Partner with investigators and clinical site staff to strengthen site relationships and position the organization as a preferred clinical research partner.
- Support the adoption of digital technologies and innovative trial approaches to improve study execution and site engagement.
- Participate in continuous improvement and change management initiatives within clinical operations.
Qualifications & Experience
- 2–5 years of experience in Clinical Operations, Clinical Research, or related areas.
- Knowledge of drug development processes and clinical trial operations.
- Experience ensuring compliance with ICH, GCP, and regulatory guidelines.
- Strong organizational, planning, and problem-solving skills to support clinical programs and studies.
- Ability to work in collaborative, fast-paced environments with evolving priorities.
- Effective communicator with the ability to share information clearly and collaborate across global teams.
- Experience supporting clinical trial execution across multiple regions or functions preferred.
- Ability to manage moderately complex projects with manageable risks and resource requirements.
- Demonstrated ability to support continuous improvement initiatives and operational optimization.
The Clinical Affairs Manager will provide clinical expertise, insight, and support to clinical end-users, clinical sales specialists, sales team, Regulatory, Engineering, marketing, and other corporate departments on safe and effective use of the Teleflex Medical product portfolio with primary emphasis on the Coronary/Structural Heart franchise. This position will support the appropriate clinical application of the Coronary/Structural Heart franchise via didactic, web-based, and teleconference education, and understanding of these products and best practices. Clinical support will be provided to physicians, nurses, techs, etc., to include support for live cases/proctorships in the therapeutic areas related to focus products. The Clinical Affairs Manager will drive innovation by identifying product attributes necessary to expand into new markets, or capitalize on new clinical applications; identify new, clinically driven product and market opportunities; and perform other related duties as required. Provide support during society engagements, facilitating the exchange of scientific information in close collaboration with CMA leadership and the broader clinical affairs interventional team.
Customer Experience Representing Teleflex in a customer-facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics to strengthen the Teleflex brand and relationship with our customers. Continuous Improvement - Demonstrates initiative and critical thinking to identify, prioritize process and performance gaps. Develops solutions to deliver improved results. Exemplifies continuous improvement thought processes and focus. Culture and Values Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Identify and support BU field efforts for the Coronary/Structural Heart franchise through clinical and educational customer needs assessment, product and procedural training, live case coverage, and assist with customer follow-up for ongoing clinical support as needed. Maintain and develop expertise on the Coronary/Structural Heart Interventional product portfolio related to the specific clinical specialty area and expertise. Identify and expand the customer base through professional networking, consultation related to best practices and the appropriate clinical use of Teleflex products, and timely professional follow-up. Support Coronary/Structural Heart educational programs with aligned educational goals and needs of the Interventional Business Unit. Support scientific exchanges of information with medical societies. Pre-conference & in-booth educational programs, meetings with scientific committees, education grant support, and research submissions (in collaboration with the Global Research & Scientific Services team). Off-label support for Teleflex products in accordance with Teleflex policy & local legal regulations
Manage utilization of HCPs in accordance with Teleflex IPPs. Coordinate efforts between cross-functional partners, including Medical Affairs, Global Research & Scientific Services, marketing, and R&D. Coordinate, participate, and manage educational, scientific activities at identified local, regional, and national trade shows/exhibitions. Serve as part of the CMA clinical expert team on product applications and troubleshooting when interfacing with SBU Leadership, Clinical Sales Specialists, and Teleflex team members. Participate as a clinical expert on project teams, committees, and in meetings with various corporate departments to provide guidance as to the clinical perspectives for the Coronary/Structural franchise. Build and support infrastructure for speaker programs supporting Teleflex Academy, webinars, training content, and programs. Coordinate and participate in content development and review of education material as needed by IA BU or CMA. Manage all business-associated administrative tasks and responsibilities to support job-related activities, to include strict adherence to the Teleflex Medical T&E policies and procedures, timely filing of required and/or requested reports, and documentation of activities via approved documents and forms. Adhere to applicable Teleflex IPPs, Teleflex Code of Ethics, and all Company policies, rules, procedures, and housekeeping standards.
Bachelor's degree is required, preferably in clinical, biology, health sciences, or engineering. Procedural experience within Interventional Cardiology and/or Structural Heart Possess a minimum of five years' clinical exposure in the medical field in the Cardiology environment. Medical Device industry supporting Clinical and Medical Affairs, strongly preferred. Proficient in Microsoft Word, Excel, and PowerPoint required; SalesForce experience preferred.
Remote working/work at home options are available for this role.
About the Role
Kolon TissueGene, Inc. is seeking an Associate Director, Clinical Quality Assurance responsible for maintaining the Quality Management System and other programs to support Clinical Operations and commercialization of biopharmaceutical products. This role will ensure that all Clinical QA details are managed efficiently and exhibit continuous improvement.
Reporting to the Head of Quality Assurance, this role will support Inspection Readiness, regulatory Inspections, Quality policies and procedures. The Associate Director, Quality Assurance will work with Clinical Operations and Regulatory Affairs to ensure adherence to KTG policies, programs, and procedures in support of commercialization. A fundamental measure of success for the position will be a successful BLA Approval Inspection and launch of commercialized drug products.
This position is based on-site at our Rockville, Maryland headquarters.
Key Responsibilities
Quality Systems Leadership
- Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including Change Control, Deviations, Complaints, Vendor Management, and Audit programs.
- Ensure quality processes and systems meet FDA and global regulatory expectations.
- Oversee electronic quality systems supporting training management and GxP document control.
Clinical Quality Oversight
- Drive the GCP Quality strategy across clinical development programs.
- Provide independent Quality oversight of Clinical Operations to ensure compliance with regulatory and internal quality requirements.
- Review and approve clinical and nonclinical documentation, including protocols, amendments, deviations, CAPAs, and change controls.
- Oversee the development and maintenance of Clinical SOPs.
- Manage training qualification and compliance for Clinical Operations and Data Management teams.
Inspection Readiness & Regulatory Support
- Lead inspection readiness activities across clinical programs.
- Serve as a lead representative during FDA inspections and vendor audits.
- Support regulatory interactions including GCP inspections, Pre-Approval/BLA inspections, and investigator site inspections.
- Ensure clinical programs maintain inspection-ready documentation and processes.
Risk Management & Continuous Improvement
- Lead quality risk management initiatives, facilitating risk assessments and implementing mitigation strategies.
- Identify opportunities for process improvements and quality system enhancements.
- Ensure quality initiatives and projects are properly resourced and executed within established timelines.
Leadership & Team Development
- Build and lead a high-performing Clinical QA team.
- Manage hiring, coaching, and development of Quality staff.
- Promote a culture of quality, compliance, and “first-time-right” execution.
- Ensure team members maintain appropriate training and qualifications.
Operational & Strategic Support
- Develop and manage Quality department timelines, budgets, and resource planning.
- Provide regular updates to senior leadership and project teams regarding Clinical QA activities and inspection readiness.
- Manage Quality vendor relationships and contracts, including quality consultants and electronic quality system providers.
Qualifications
Education
- Bachelor’s degree in Biological Sciences, Life Sciences, Physical Sciences, or a related discipline required
- Advanced degree (M.S., Ph.D., or equivalent) preferred
Experience
- 10+ years of experience in the biopharmaceutical industry, with a minimum of 8 years demonstrated experience of direct interaction with FDA and other regulatory agencies through GCP, Pre-Approval/BLA Inspections, and Investigator Site inspections.
- 6+ years of leadership experience in Clinical Quality Assurance roles
- Experience developing, implementing, and maintaining Quality Management Systems (QMS)
- Experience working with Clinical Operations and Regulatory Affairs teams in regulated development environments
- Experience in cell and gene therapy programs or advanced biologics preferred
Core Competencies
- Strong knowledge of ICH guidelines, FDA regulations, and GCP compliance requirements
- Expertise in Quality Management Systems, including change control, deviations, CAPA, audits, and vendor oversight
- Ability to maintain independent Quality oversight of Clinical Operations
- Strong leadership, organizational, and team development skills
- Excellent written and verbal communication skills
- Strong problem-solving and risk management capabilities
- Demonstrated commitment to quality, compliance, and continuous improvement
Work Environment & Physical Requirements
- On-site position with up to approximately 20% travel.
- Extensive computer and keyboard use involving repetitive motion.
- Regular telephone and in-person communication.
- Ability to lift up to 25 pounds, with or without reasonable accommodation.
Kolon TissueGene will provide reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state law.
Why Join Kolon TissueGene?
Kolon TissueGene is advancing innovative regenerative cell and gene therapies designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients.
About Us
Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact.
Benefits Highlights:
- Onsite yet Flexible work schedules
- Premium-free global health insurance (50% dependent coverage)
- 401(k) with immediate eligibility
- Long-term incentive bonuses
- On-site gym & wellness perks
- Extra PTO accrual every year
- Global and local training opportunities
- Visa sponsorship available for qualified candidates
Equal Opportunity Employer
Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.
Apply today to shape the future of regenerative medicine with precision, rigor, and purpos
Sr Specialist, Clinical Development
Duration - 8 Months
Location - Irvine, CA
Pay Rate:- $55.00-$66.92/hour, depending on experience
Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
Key Responsibilities:
*Ensure successful product lifecycle management, from early human use through commercial submission
*Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
*Provide scientific rationale for product attributes and pre-clinical test results
*Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel
* Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
* Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.
* Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
* Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
* Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
*Analyze data to support clinical trial safety investigations and new product development
*Other duties as assigned by leadership
Education and Experience:
Bachelor's Degree in biology or lifesciences field, 5 Years years experience Class II and III medical device technologies and/or clinical studies background Required
Bachelor's Degree in engineering Preferred
Additional Skills:
* Proven expertise with computer skills - Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
* Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
* Experience with pre-clinical testing protocols, hospital environments and sterile techniques
* Data analysis skills, with understanding of statistical analysis techniques
* Good communication and organizational skills
* Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
* Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
* Demonstrated problem-solving and critical thinking skills
* Thorough, conscientious and results oriented working style
* Team oriented
* Ability to work in a dynamic work environment
* Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
* Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.
The West Division of Labcorp is seeking a Clinical Chemist Technical Director. This position will focus primarily on Clinical Toxicology and Mass spectrometry in the Portland and Spokane Laboratories. The PhD level position will be responsible for providing direction and to serve as the technical advisor and clinical consultant for clinical toxicology, mass spectrometry and clinical chemistry for the laboratories.
Reporting to the Senior Clinical Chemist, West Division, the Clinical Chemist Technical Director will join an incredible team of two Clinical Chemist and two Medical Microbiologists who provide technical and clinical oversight for testing over four regional laboratories.
Candidates must be board-certified or board-eligible by the American Board of Clinical Chemistry and have experience and/or training is clinical toxicology and maintaining mass spectrometry assays.
Work Schedule: 1st shift
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Responsibilities:
- Reviews and reports patient results accurately, and with integrity
- Accurately and promptly responds to client inquiries that are technical in nature
- Effectively communicates with clients, physicians, nurses, pathologists and Labcorp staff and Laboratory teams
- Oversees the technical component of the laboratory to ensure that patient results are reported reliably and in a timely fashion.
- Ensures accuracy for all chemistry testing in the lab, including instrument performance and addressing root causes when issues arise
- Guides implementation of new assays and instrumentation in the lab in collaboration with the research and development team
- Makes recommendations to improve workflow, support staffing needs as well as optimization of reagent utilization
- Serves as last-stop to solve clients' technical problems (i.e., test rejection)
- Assists the Quality department to ensure all required regulations are followed
- Projects credibility and builds rapport with medical providers/Labcorp clients, providing quick/accurate responses to inquiries
- Keeps up with scientific advances and other literature, offering perspectives about improvements, such as how a report reads
- An interest in providing staff educational seminars, participation in national clinical societies and publishing peer-reviewed manuscripts is encouraged
- Sets the tone in the lab for performance and quality
- Shares experiences and ideas with discipline directors, such as improvements to SOPs, reports, interfaces
- Works effectively and efficiently with the Laboratory Site Director on the above functions and as deemed necessary
- Other duties as needed.
Requirements:
- PhD with Board Certification from the American Board of Clinical Chemistry (DABCC), or DABCC board eligibility. Candidates with clinical chemistry fellowship training are strongly encouraged to apply.
- The position is based on-site in the Labcorp Portland Laboratory. Travel to the Spokane laboratory quarterly is highly encouraged.
- Training in a COMACC fellowship is preferred
- Expertise in clinical toxicology and mass spectrometry
- Leadership skills to work with laboratory staff, developing their capabilities and involving them in problem-solving/urgent matters
- Deductive reasoning/analytical skills to reach a resolution to customer inquiries or lab opportunities/issues
- Depth and breadth of experience within a clinical lab, understanding validation, quality control and quality management; proficiency testing; and regulatory requirements
If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, apply today!
The Heart & Vascular Clinic Operations Director provides strategic and operational leadership for ambulatory services across the Cardiology (general & invasive), Electrophysiology (EP), Vascular, and Interventional Radiology (IR) clinics. This role ensures clinical operations deliver patient centered care that focuses on access, growth, quality outcomes and patient experience. The Director partners closely with appropriate stakeholders to optimize the continuum from referral to procedure to follow up.
Key Responsibilities
Operational Leadership & Access
- Lead day to day operations for multi site Heart & Vascular clinics, including Cardiology (general and invasive consults), EP, Vascular, and IR ambulatory pathways.
- Assumes 24-hour responsibility for assigned areas of operations.
- Own access and capacity management: templates, scheduling rules, slot utilization, referral triage, and wait time reduction for new and follow up patients.
- Standardize clinic workflows (check in, rooming, testing coordination, care transitions) and implement Lean process improvements to reduce lead time and waste.
- Coordinate pre procedure workups and clearance for invasive cardiology, EP, vascular, and IR procedures; align with cath/EP/IR lab schedules and post procedure follow ups.
- Oversee clinic staffing, daily huddles, visual management, and escalation protocols to ensure safe and reliable operations.
- Monitor and improve clinical quality measures (e.g., guideline-directed therapy adherence, anticoagulation management, device follow-up, vascular wound outcomes).
- Ensure compliance with regulatory standards (e.g., DNV), policies, and documentation standards.
- Partner with physician and nursing leaders on safety event reviews, root cause analyses (RCA), and action plans.
- Maintain competency validation, licensure tracking, and annual training for clinical and non-clinical staff.
- Develops and implements policies and procedures consistent with Riverside Healthcare’s philosophy, mission, and values.
- Develop and manage operating and capital budgets; track performance to target.
- Optimize revenue capture: charge integrity, accurate documentation, prior auth, denials prevention, and clinic coding workflows (E/M, device checks, imaging).
- Collaborate with supply chain on vendor contracting, implant/supply formularies, and inventory controls.
- Support business planning for new programs, sites, providers, and equipment (e.g., ambulatory monitoring, device clinics, vascular wound care, IR outpatient procedures).
- Drive market-appropriate growth strategies: referral development, access expansion, clinic footprint optimization, and telehealth/hybrid care models.
- Develop outreach programs with primary care and referring specialists; improve care coordination and communication pathways.
- Sponsor operational readiness for new technology and programs (e.g., advanced imaging protocols, remote device monitoring, ambulatory IR offerings).
- Achieve top decile patient experience (Press Ganey) through service standards, scripting, and service recovery.
- Promote physician satisfaction in clinical areas by rounding on providers and developing action plans to address any areas for improvement.
- Implement equity and inclusion practices; reduce barriers to care (transportation, language access, financial counseling).
- Recruit, develop, and retain high-performing teams (RNs, MAs, device techs, schedulers, access reps, RN navigators) while setting clear expectations.
- Monitors and facilitates the resolution of performance and other employee relations issues. Evaluates and holds downline of leaders accountable for employee performance in their areas. Encourage the recognition of high performers, address low performers, and improve overall employee performance.
- Promote a culture of safety, respect, accountability, and continuous improvement; lead change management with transparent communication.
- Leverage the EHR for efficient workflows (referral triage, integrated scheduling, pre procedure checklists, care gap closure).
- Use dashboards to track KPIs (access, quality, financials, patient experience); run daily/weekly operations reviews.
- Sponsor digital tools (remote monitoring, patient portal adoption, virtual visits) aligned with clinical appropriateness and access goals.
- Keeps abreast of current standards of care and new business or technology developments via internal or external networking and resources.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.
Our Commitment To You
Riverside Healthcare offers a comprehensive suite of Total Rewards: benefits and nationally rated employee well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so your journey at and away from work is remarkable. Our Total Rewards package includes:
Compensation
- Base compensation within the position’s pay range based on factors such as qualifications, skills, relevant experience, and/or training
- Premium pay such as shift differential, on-call
- Opportunity for annual increases based on performance
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Health Savings and Flexible Spending Accounts for eligible health care and dependent care expenses
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
- Paid Leave Hours accrued as you work
- Master’s degree in Healthcare Administration, Business, Nursing, or related field (or currently pursuing)
- 7+ years of progressive leadership in ambulatory or cardiovascular service line operations (Cardiology/EP/Vascular/IR preferred).
- Demonstrated experience managing multi site clinics, scheduling/access operations, and cross-disciplinary teams.
- Strong knowledge of regulatory requirements and HIPAA.
- Proven financial acumen (budgeting, productivity, revenue cycle) and process improvement experience (Lean/Six Sigma).
- RN-BSN
- Certification(s): CMPE, FACHE, CPHQ, Lean/Six Sigma Green/Black Belt.
- Experience integrating ambulatory operations with cath/EP/IR lab scheduling and post procedure follow up.
- Familiarity with device clinic operations (pacemaker/ICD), remote monitoring, ambulatory rhythm diagnostics, vascular wound care clinics, and IR outpatient procedures.
- EHR experience (Epic/Cerner) with clinic template design and access optimization.
Exposure/Sensory Requirements:
- Exposure to:
- Chemicals: N/A
- Video Display Terminals: Average
- Blood and Body Fluids: None
- TB or Airborne Pathogens: None.
- Speech: Training/presentations, telephone communication, facilitating meetings.
- Vision: Read computer screens and printouts, memos, communications, documentation, and literature.
- Smell: Sensitivity and recognition of odors derived from various cleaning processes, odors generated from malfunctioning equipment.
- Hearing: Telephone communications, meetings, and equipment operating characteristics.
- Touch: .Writing and computer entry, filing.
Percentage of time during the normal workday the employee is required to:
- Sit: 55%
- Twist: 0%
- Stand: 20%
- Crawl: 0%
- Walk: 20%
- Kneel: 0%
- Lift: 0%
- Drive: 5%
- Squat: 0%
- Climb: 0%
- Bend: 0%
- Reach above shoulders: 0%
- Up to 10 lbs: Occasionally
- Up to 20 lbs: Not Required
- Up to 35 lbs: Not Required
- Up to 50 lbs: Not Required
- Up to 75 lbs: Not Required
- Up to 100 lbs: Not Required
- Over 100 lbs: Not Required
Maximum consecutive time (minutes) during the normal workday for each activity:
- Sit: 240
- Twist: 0
- Stand: 20
- Crawl: 0
- Walk: 10
- Kneel: 0
- Lift: 0
- Drive: 5
- Squat: 0
- Climb: 0
- Bend: 0
- Reach above shoulders: 0
- Simple grasp up to 10 lbs.
- Pushing & pulling Normal weight:
- Fine Manipulation: Computer keyboard and mouse.
Environmental Factors & Special Hazards
- Environmental Factors (Time Spent):
- Inside hours: 8
- Outside hours : 0
- Temperature: Normal Range
- Lighting: Average
- Noise levels: Average
- Humidity: Normal Range
- Atmosphere:
- Special Hazards:
- Protective Clothing Required: None
USD $62.67 - USD $86.30 //Hr
Clinical Informatics Specialist, must be ON-SITE in INDIANA
Beacon Health System is seeking a Clinical Informatics Specialist to support the design, implementation, optimization, testing, training, and maintenance of clinical information systems that drive excellence in patient care and clinical operations.
This role serves as a key liaison between clinical teams and Information Systems, helping translate clinical workflows into effective technology solutions while supporting end users, data integrity, performance improvement, and system enhancements.
Responsibilities
- Support implementation and maintenance of clinical software applications
- Optimize workflows and clinical system functionality
- Troubleshoot and resolve application issues
- Develop and execute testing scenarios and validate results
- Provide training and support to clinical users and medical staff
- Monitor data integrity and support system documentation
- Partner with clinical and IS teams on performance improvement initiatives
Qualifications
- Associate's or Bachelor’s degree in a clinical discipline
- Current Indiana licensure, if applicable
- 3–5 years of progressively responsible clinical experience
- Strong understanding of clinical operations and workflows
- Experience with EHRs or clinical information systems
- Excellent communication, analytical, and training skills
Preferred
- Clinical Informatics program graduate
- RN - Registered Nurse
- Informatics certification
- Epic or other relevant clinical systems experience
- Prior leadership experience
Position Summary:
The Clinical Nurse Educator is responsible for assessment, planning, implementing, and evaluating clinical education processes in defined specialty areas. Adult learning theories are utilized when formulating and implementing educational programs/activities for staff, clients, and the community. The Clinical Nurse Educator acts as a consultant and change agent in the development of standards of care for clinical practice; utilizes and applies change theory in matters related to clinical practice; applies interpersonal skills and fosters communication when interacting with staff, patients, and other members of the healthcare organization. The Clinical Nurse Educator is self‐directed in maintaining clinical competencies; pursues continued excellence in clinical practice; is self‐motivated in identifying own strengths and limitations; and seeks to improve areas of weakness. The Clinical Nurse Educator is not administratively responsible for the supervision of other people, but works collaboratively with Nursing Managers to assure that standards of clinical practice are met.
Education, License & Cert:
The Clinical Nurse Educator must have a BSN and current state specific licensure as a Registered Professional Nurse. The Clinical Nurse Educator must have a master's degree in nursing from an accredited program or be currently enrolled in a program leading to an MSN within 1 year of employment, and must complete this degree within 3 years of hire. They must also be certified in Nursing Professional Development, preferred, or an area of clinical specialty, as soon as eligible
Experience:
A minimum of three years direct clinical experience in the specialty/with the population served and demonstrated abilities in teaching, leadership skills, and clinical nursing practice.
Essential Functions:
A. Orientation/Onboarding
1. Collaboratively develops, coordinates and evaluates the system orientation program for nurses, nursing support staff and nurse leaders in conjunction with other Clinical Nurse Educators.
2. Participates in the assessment, maintenance and development of staff competencies on initial employee hire.
3. Supports the Newly Licensed Registered Nurse Residency program (Transition to Practice) including preparation of preceptors, goal‐setting, and on‐going evaluation.
B. Competency Management
1. Participates in the assessment, maintenance and development of ongoing staff competencies
2. Conducts or coordinates in‐services for new products and equipment
C. Education
1. Collaborates with nursing staff, and Nurse Managers to identify educational criteria to promote high quality nursing care.
2. Supports Resuscitation Quality Improvement (RQI) training and serves as a resource to staff utilizing this technology.
3. Assists in appropriate multidisciplinary education with the hospital by being a planner of and/or participant in professional programs.
4. Represents Nursing Professional Development at the organizational and system level on committees/teams requiring education of nursing staff. Collaborates with other educators across the system to develop appropriate education.
5. Organizes, conducts, and evaluates in‐service and continuing education programs for the nursing department.
6. Maintains records of educational programs and activities of the nursing department.
1. Professional Role Development 1. Implements and supports the Nursing Department philosophy and objectives.
2. Encourages development of leadership skills in members of the nursing staff.
3. Provides clinical expertise for administrative decision making.
4. Utilizes principles of change theory to effect smooth processes of change.
5. Participates in the interview process of applicants for nursing positions involving leadership or expanded role function when appropriate and/or requested.
6. Serves as a role model for professional communication skills during interactions with other health team members.
E. Research/Evidence Based Practice/Quality Improvement
1. Collaborates with peers in the identification and the conduction of research to further knowledge of clinical practice or staff development.
2. Keeps informed of current nursing practice advancements and research findings and provides for dissemination of research developments.
3. Advances nursing practice through evidence‐based practice.
4. Advances professional nursing through publication, organizations, and other activities.
5. Supports performance improvement activities by developing appropriate education related to the topic.
6. Assists in the analysis of “Confidential Quality Reports” data and information and provides risk management and problem oriented educational opportunities as necessary and as requested.
F. Collaborative Partnerships
1. Collaborates with Affiliating Agencies to coordinate learning experiences for Student Nurse learners.
2. Coordinates/participates in interprofessional learning activities that includes nursing staff.
Other Duties:
1. It is understood that this description is not intended to be all‐inclusive, and that other duties may be assigned as necessary in the performance of this position.
2. Encouraged to participate in community activities.
3. Is authorized to access medications and storage areas in the performance of essential job functions and duties.
In collaboration with the management team focuses on daily department operations. Supervises personnel and coordinates shift activities of Nursing. Performs all duties in a manner that promotes team concept and reflects the mission and values at Guthrie Robert Packer Hospital. Serves as a role model for nurses, physicians, and department support staff, exhibiting the Core Values in all activities. Mentors under the Clinical Manager / Director and pursues management and leadership training within the Guthrie Robert Packer Hospital. May be assigned to special projects per Clinical Manager / Director consistent with strategic, fiscal, quality and operational goals/targets.
In collaboration with management, coordinates the team to deliver patient care in a compassionate and ethical manner according to recognized standards and care model. Functions as the clinical & operating resource with designated hours of accountability exercising independent judgment. Ensures compliance with entity/department goals and clinical resource utilization. Promotes change and teamwork. Performs clinical duties of the patient care role related to professional specialty.
Education, License & Cert:
- Licensed as a Registered Nurse in the State of Pennsylvania/New York.
- Certification within area of expertise or practice preferred (Nursing Management, CCRN, CEN, etc.)
- BSN required within 3 years.
- Masters preferred.
Experience:
- Two years of recent clinical supervisory experience or charge nurse experience desired
Essential Functions:
1. RESOURCE UTILIZATION; Considers factors related to safety, effectiveness, cost, and impact on practice in the planning and delivery of nursing and other services. Utilizes staffing management principles to assure adequate supply of all necessary staff to perform patient care. Manages daily staffing issues in conjunction with Nurse Manager/Assistant Nurse Manager, analyzing available data sources, and making decisions based on this data. Adjusts daily schedules according to changes in staffing needs, due to patient census or acuity. Responsible for daily performance against budget targets. Assists in the development, implementation and modification of programs and services needed to meet patient care and staff development needs.
2. LEADERSHIP; Uses leadership principles to anticipate and influence change. Determines resources and actions needed to accomplish objectives. Sets priorities and manages time effectively. Identifies potential problems/opportunities and plans contingent action. Collaborates with the nurse manager / director, assistant nurse managers, , patient care staff and informal leaders in these efforts. Seeks creative methods to resolve conflicts. Promotes multi-disciplinary care of the patient. Keeps Nurse Manager / Director informed of clinical issues, triage problems, staffing issues, and risk management concerns. Acts on behalf of nurse Manager / Director in his/her absence.. QUALITY OF PRACTICE; Monitors and guides clinical practice expectations based on established goals and evidenced-based directives while incorporating individual unit needs. Able to provide clinical care and is a role model for staff in the clinical setting. Responsible for overseeing clinical operations and throughput of the clinical department. Works with Nurse Manager / Director, Medical Director, and clinical staff to develop, modify and implement patient care standards. Working with clinical staff, evaluates best practices and compliance with established goals for clinical practice. Role models customer service standards of the Guthrie Robert Packer Hospital. Responds to customer requests and complaints promptly and with courtesy. Fosters a supportive environment and works towards service recovery when necessary. Effectively advances improvement activities. Implement care/services that recognize age/diversity specific needs/issues of customers served. COLLABORATION; Establish shift assignments and Creates supporting systems that enable staff to jointly plan and deliver care. Role models collaboration and partnership with the patient care team. Utilizes shift huddles and performance boards with direct report staff to assure communication related to clinical care compliance and established goals.Collaborates with staff, physicians, and all appropriate departments to promote optimal patient care and customer service.
3. COMPLIANCE; Supports the implementation of organization policies and procedures in compliance with state, Federal and other regulatory guidelines to help ensure that high quality, cost effective patient services meet or surpass accreditation standards. Maintains confidentiality of all information related to patients, employees, medical staff, and as appropriate, Guthrie Robert Packer Hospital. Responsible to develop and coordinate, with assistance of the clinical manager / director, and clinical educator,, department competencies, educational programs, new employee orientation, and annual skills labs. Keeps current with advances in nursing practice and technology, sharing knowledge with the staff on a regular basis.
4. EDUCATION/PROFESSIONAL PRACTICE EVALUATION: Assumes responsibility for obtaining information and expanding job knowledge and competency that reflects current practice. Role models personal development and education. Evaluates own practice in relation to professional practice standards and guidelines, relevant statutes, rules, and regulations.
5. ADVOCACY/ETHICS; Advocates for the protections and rights of individuals, families, and staff, especially related to health and safety. Integrates ethical provisions in all areas of practice.
6. RESEARCH; Assists in the development, implementation and modification of programs and services needed to meet patient care and staff development needs.
7. HUMAN RESOURCE STEWARDSHIP; Uses appropriate interpersonal skills to guide others to accomplish objectives. Facilitates teamwork, participation, and cooperation. Delegates work so subordinates have the necessary direction, authority, and skills to complete assignments. Role models positive employee relations, using evaluation and management techniques and criteria, which are consistent and fair yet flexible enough to support employee and department needs. Assures timely performance evaluations that reflect validated competence, safety, and quality standards of practice. Counsels staffappropriately and is competent in conflict management. Uses independent judgment, after consultation with clinical staff, to recommend and/or take action related to interviews, new hires, transfers, promotions, evaluations, and performance management issues. In collaboration with manager / director recommends promotions, supports disciplinary actions, and investigates and follows through with employee complaints and concerns.
Other Duties:
1. Performs other related duties as required.
Rev: 12-05-2023
Summary:
The Lead Specialist Clinical Operations plays a pivotal role in driving our growth and profitability by leading the planning and execution of complex clinical studies. This senior role involves enhanced responsibility for leadership and oversight of clinical operations, ensuring compliance with Sponsor SOPs, Good Clinical Practice, and other relevant clinical research regulations and guidelines including but not limited to FDA Code of Federal Regulations, ISO, and MDCG. The Lead Specialist Clinical Operations serves as a resource and mentor within the Global Clinical Affairs (GCA) department. Role will regularly collaborate with GCA study team members (Clinical Project Management, Biostatistics, Data Management, Clinical Scientist) and cross-functional team members (Regulatory, Quality, R&D, and others). Develops working relationships with and acts as the primary contact for study Investigators, Site Research Staff, ethics committees, and regulatory authorities.
Responsibilities:
Clinical Study Operations Leadership
- Acts as a member of the GCA study team and contributes strategic input on protocols and supporting essential study documentation as it relates to clinical operations, recruitment, and compliance topics.
- Develops and maintains strategic relationships with key external stakeholders to optimize clinical trial performance. Represents the company at major scientific meetings and contributes to scientific presentations and publications.
- Manages ethics submissions, correspondence, and close out. Responsible for coordinating with relevant GCA study team members to address queries within the required timeframe.
- Leads study recruitment, retention, and compensation efforts.
- Responsible for shipment of study devices and supplies to clinical sites and/or subjects. Also responsible for maintaining study device accountability throughout each study (initial, interim, and final).
- Oversees management of the GCA study product lab.
Clinical Study Compliance Oversight
- Leads the collection and storage of all required eTMF documents as required by Site, Sponsor, and/or CRO.
- Oversees eTMF internal processes are followed and leads GCA in conducting periodic internal review audits to ensure inspection readiness.
- Oversees study research staff and study progress to ensure protocol procedures are adhered, are complete, and maintain compliance with regulatory standards.
Advanced Site/Investigator Management
- Directs the operational aspects of assigned studies, implementing strategies to enhance site performance and compliance. Provides advanced training to site staff, oversees critical safety and efficacy trend analyses, and ensures rigorous adherence to protocol and GCP.
- Oversees contract development and negotiations for clinical sites, investigators, CROs, and other study vendors.
- Manages investigators, clinical sites, CRO, and other study vendor relationships.
- Leads clinical site and investigator pre-study qualification and re-qualification audits.
- Leads on-site and remote site monitoring visits (selection/qualification, initiation, interim, and close-out) to evaluate compliance in accordance with contracted scope of work and regulatory requirements.
- Completes monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance. Escalates issues.
Process Improvement
- Responsible for leading process improvements within clinical operations, ensuring compliance with relevant guidelines and contributing to the development and updating of clinical SOPs.
Mentorship and Training
- Provides guidance and professional development support to junior Clinical Operations staff, fostering professional growth within the team.
Essential Functions of the Role:
- Excellent oral communication skills, communication skills, and problem solving.
- Must be able to travel up to 25% of the time. Must maintain current driving license and passport.
Work Experience Requirements
- Number of Overall Years Necessary: 8-12
- Minimum of 4 years of clinical research monitoring experience.
- Extensive experience with clinical research studies and clinical operations tasks.
- Prior experience managing ethics submissions is required.
Education Requirements
- B.S. or B.A. degree in a scientific field.
- CRA certification preferred.
- Minimum of 4 years of clinical research monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
Specialized Skills/Technical Knowledge:
- Expertise in clinical research processes, including comprehensive knowledge of FDA CFR, Good Clinical Practices, ICH, ISO, and MDCG.
- Proficiency in Microsoft Office Suite and project management tools.
- Advanced knowledge in medical device clinical research, particularly in areas such as wound care, ostomy, critical care, and/or continence care.
