Education And Training Jobs in Silver Spring

Safety Monitor II

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements.

• Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members.
• Reviews safety events.
• Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
• Provides first line evaluation of serious adverse events (SAEs).
• Communicates with site staff regarding reported AEs or SAEs to gather additional information.
• Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• Coordinates the timely completion and submission of required reports to health authorities and business partners.
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
• Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
• Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non interventional).
• Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary.
• Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports.
• Coordinates with project staff.
• Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
• Contributes to the development and implementation of safety related Case Report Forms (CRF) and SaMP.
• Ensures maintenance of documentation required by both corporate and project SOPs.
• Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Guarantees compliance and adherence to the quality standards.
• Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned.
• Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract.
• Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
• Completes all relevant professional training in the given scope and time frame.
• Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives.

• Bachelor's Degree in Pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice, example pharmacy, inpatient or outpatient healthcare facility, or clinical research center.
• 1-3 years in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) required
• Experience in safety monitoring/pharmacovigilance preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

• Provides comprehensive diagnostic evaluations to patients with speech, language and/or swallowing disorders, including head-neck cancer patients.

• Establishes treatment goals and develops therapeutic programs. Makes determinations as to whether patient may continue eating orally, or if an alternate peripheral nutritional method is required . Provides esophageal voice training, tracheoesophageal voice training, and training in prosthetic devices. Conducts and interprets video fluorography. Conducts invasive tracheoesophageal puncture evaluations.

• Summarizes test results and prognostic evidence. Completes progress notes and related documentation in medical records and responds to referral source(s) . Maintains statistical data as required by department . Determines appropriate period when therapy can be discontinued based on patient's performance and progress. Arranges for follow-up care as required .

• Performs hearing screening as required . Completes all required documentation for patient billing. Participates in interdepartmental rehabilitation team meetings, discharge rounds and family conferences. Presents speech-language in-services to nursing staff, Rehabilitation Department, and medical residents as assigned. Provides guidance to and may serve as a professional resource for graduate students completing a clinical practicum.

• Maintains current knowledge of trends and developments in the field by reading appropriate books , journals, and other literature, and by attending related seminars and conferences.

• Master's degree in Speech-Language Pathology.

• 1-2 years of progressively more responsible job-related experience.

• ASHA - American Speech Language Hearing Association.

• SP-L - Licensed Speech-Language Pathologist in the District of Columbia within 90 Days.

• Provides comprehensive diagnostic evaluations to patients with speech, language and/or swallowing disorders, including head-neck cancer patients.

• Establishes treatment goals and develops therapeutic programs. Makes determinations as to whether patient may continue eating orally, or if an alternate peripheral nutritional method is required . Provides esophageal voice training, tracheoesophageal voice training, and training in prosthetic devices. Conducts and interprets video fluorography. Conducts invasive tracheoesophageal puncture evaluations.

• Summarizes test results and prognostic evidence. Completes progress notes and related documentation in medical records and responds to referral source(s) . Maintains statistical data as required by department . Determines appropriate period when therapy can be discontinued based on patient's performance and progress. Arranges for follow-up care as required .

• Performs hearing screening as required . Completes all required documentation for patient billing. Participates in interdepartmental rehabilitation team meetings, discharge rounds and family conferences. Presents speech-language in-services to nursing staff, Rehabilitation Department, and medical residents as assigned. Provides guidance to and may serve as a professional resource for graduate students completing a clinical practicum.

• Maintains current knowledge of trends and developments in the field by reading appropriate books , journals, and other literature, and by attending related seminars and conferences.

• Master's degree in Speech-Language Pathology.

• 1-2 years of progressively more responsible job-related experience.

• ASHA - American Speech Language Hearing Association.

• SP-L - Licensed Speech-Language Pathologist in the District of Columbia within 90 Days.

Float Registered Nurse role PURPOSE AND SCOPE: The professional registered nurse Outpatient RN CAP 2 may be an entry level designation into the Clinical Advancement Program (CAP) for new employees who meet the RN CAP 2 criteria or attained through advancement from RN CAP 1.

This position is accountable and responsible for the provision and coordination of clinically competent care including assessment, planning, intervention, and evaluation for an assigned group of patients.

This may include delegation of appropriate tasks to direct patient care staff including but not limited to RNs, LVN/LPNs, and Patient Care Technicians.

As a member of the End Stage Kidney Disease (ESKD) health care team, this position participates in decision-making, teaching, leadership functions, and quality improvement activities that enhance patient care outcomes and facility operations.

PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties and responsibilities are expected to be performed in accordance with Fresenius Kidney Care policy, procedures, standards of nursing practice, state, and federal regulations.

Performs all essential functions under the direction of the Supervisor and with guidance from the Clinical Educator, Preceptor or in collaboration with other Registered Nurses.

Performs ongoing, systematic collection and analysis of patient data pre – during – post hemodialysis treatment for assigned patients and documents in the patient medical record, makes adjustments or modifications to treatment plan as indicated and notifies Team Leader, Charge Nurse, Supervisor or Physician as needed.

Assesses, collaborates, and documents patient/family’s basic learning needs to provide initial and ongoing education to patients and family.

Directs and provides, in collaboration with direct and ancillary patient care staff, all aspects of the daily provision of safe and effective delivery of hemodialysis therapy to assigned patients.

Administers medications as prescribed or in accordance with approved algorithm(s), and documents appropriate medical justification and effectiveness.

Initiates or assists with emergency response measures.

Serves as a resource, leader, coach, mentor and role model for new and incumbent employees by setting examples of appropriate behavior, work habits and attitudes towards patients, co-workers, supervisors and the company at the facility, and area level.

Ensures correct laboratory collection, processing and shipping procedures are performed and reschedules missed or insufficient laboratory collections.

Identifies expected outcomes, documents, and updates the nursing assessment and plan of care for assigned patients through collaboration with the Interdisciplinary Team.

Ensures patient awareness related to transplant and treatment modality options.

Participates in education and quality improvement projects at the facility and area level as directed by Supervisor.

May serve as a Preceptor to new employees.

Required to complete CAP requirements to maintain or advance.

Performs all other duties as assigned by Supervisor.

PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The position provides direct patient care that regularly involves heavy lifting, moving of patients and assisting with ambulation.

Equipment aids and/or coworkers may provide assistance.

This position requires frequent, prolonged periods of standing and the employee must be able to bend over.

The employee may occasionally be required to move, with assistance, machines, and equipment of up to 200 lbs., and may lift chemical and water solutions of up to 30 lbs.

as high as 5 feet.

The work environment is characteristic of a health care facility with air temperature control and moderate noise levels.

May be exposed to infectious and contagious diseases/materials.

Day to day work includes desk work, computer work and interaction with patients, facility/hospital staff and physicians.

The position may require travel to training sites or other facilities.

May be asked to provide essential functions of this position in other locations with the same physical demands and working conditions as described above.

SUPERVISION: Assigned oversight of Patient Care Technicians//LVN/LPNs/RNs as a Team Leader or designated Nurse in Charge, after meeting all the following: Successful completion of all FKC education and training requirements for new employees.

Must have a minimum of 3 months experience in chronic/acute hemodialysis as a RN.

EDUCATION and LICENSURE: Graduate of an accredited School of Nursing.

Current appropriate state licensure.

Current or successful completion of CPR BLS Certification Must meet the practice requirements in the state in which he or she is employed.

EXPERIENCE AND REQUIRED SKILLS: Entry level for RNs with minimum of 2 years of Nephrology Nursing experience The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Hourly Rate: $35.00
- $59.00 Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.

EOE, disability/veterans

About Covista


Covista is America's largest healthcare educator, serving more than 97,000 students and supported by a community of 385,000 alumni across five accredited institutions. Through personalized, tech-enabled education powered by 10,000 faculty and colleagues, Covista expands access to healthcare careers and addresses the U.S. healthcare workforce shortage at scale. Covista is the parent company of American University of the Caribbean School of Medicine, Chamberlain University, Ross University School of Medicine, Ross University School of Veterinary Medicine and Walden University.

Our colleagues come from a wide range of backgrounds, business, academia, healthcare, government and nonprofits, and are part of a culture where doing exceptional work and making a meaningful difference for students and society aren't separate goals—they're one and the same. This means creating an environment where colleagues can develop new skills, build careers that match their ambitions and see the tangible impact of their work on healthcare education and workforce development. Colleagues who deliver results and embrace new tools to work smarter are valued for their contributions. But what makes working at Covista distinctive is our impact. Our faculty and colleagues don't just support healthcare education—they shape it. This isn't abstract purpose work. It's solving real problems for real people in real communities while advancing careers.

We operate on a hybrid schedule with four in-office days per week (Monday–Thursday). This approach enhances creativity, innovation, communication, and relationship-building, fostering a dynamic and collaborative work environment.

For more information, visit and follow us on LinkedIn, Instagram and YouTube.

The role is responsible for promoting student success through accurate and responsive advisement in student finance and service-related areas, providing support and advocacy as needed for students throughout the student lifecycle. This position is responsible and accountable for the advisement of students within their group and serving as a primary point of contact for the student(s) within their assigned portfolio. Supports students with Financial Aid advising and awareness of overall financial literacy to succeed in their educational goals. Function as a role model for our Covista values and fosters a culture of CARE consistent with our mission, vision, and purpose.

Responsibilities

• Supports the new student intake process by working with admissions to answer incoming student questions, provide a thorough review of program and student costs, and outline all possible options to fund their education.

• Create and confirm an accurate financial plan by establishing timeframes to complete any application process to be financially prepared to start and stay in school. Continuously reviews student accounts to advise students on their financial eligibility.

• Responsible for maintaining student satisfaction through facilitation of inbound and outbound phone calls, emails, and SMS communication with students and internal stakeholders to Student Finance

• Using a high level of discretion and independent judgment continuously evaluates the financial plans throughout the student lifecycle and makes appropriate adjustments to ensure successful student outcomes.

• Utilizes appropriate systems and student data to confirm and track accurate enrollment, persistence, and graduation information for assigned students.

• Accurately and thoroughly documents all interactions in the appropriate institutional systems.

• Analyzes student data to identify triggers, indicating a need for proactive outreach to understand challenges and successes better. Coaches students to explore alternatives to overcome barriers to persistence or graduation. Makes appropriate resource referrals when necessary.

• Collaborates with other departments and functional areas to deliver an optimal student experience from inquiry to graduation.

• Maintain a thorough understanding of all Title IV programs, policies, and procedures, including institutional and international, federal, and state regulations. Complies with applicable international, federal, and state laws.

• Identifies opportunities and solutions that improve current methods and actively participates in the change of a constantly evolving organization. Promote student self-service tools during advising sessions and new student orientation.

• Engages students through a variety of communication channels. This may include video advising, inbound student calls, and proactive outreach to students to deliver first contact resolution.

• Performs other duties as assigned

• Complies with all policies and standards
  
  

• Bachelor's Degree Required.
• Outstanding customer service skills with 1+ years of customer service or related experience Required.
• 1+ years of experience in Higher Education Preferred.
• Experience with Student Financial Aid software application Preferred.
• Ability to work a variety of office hours, including evenings, weekends, and travel as needed.
• High level of interpersonal, communication, and problem-solving skills.
• Ability to work independently as well as function as part of a team.
• Must be a self-starter with the ability to prioritize effectively.
• PC skills in Microsoft Office, Internet applications, and database software.
• Eligible to obtain and maintain systems access to the NSLDS system (must not be in default of Title IV Federal aid).
• Self-motivated and willing to take ownership of and quickly resolve complex issues.
  
  

In support of the pay transparency laws enacted across the country, the expected salary range for this position is between $20-25/hr. Actual pay will be adjusted based on job-related factors permitted by law, such as experience and training; geographic location; licensure and certifications; market factors; departmental budgets; and responsibility. Our Talent Acquisition Team will be happy to answer any questions you may have, and we look forward to learning more about your salary requirements. The position qualifies for the below benefits.

Covista offers a robust suite of benefits including:

• Health, dental, vision, life and disability insurance
• 401k Retirement Program + 6% employer match
• 15 Days of Paid Vacation Days each Calendar Year
• 12 Paid Holidays + 2 floating holidays
  
  For more information related to our benefits please visit:
  
  

Equal Opportunity – Minority / Female / Disability / V / Gender Identity / Sexual Orientation