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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.
Responsibilities
- 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.
Qualifications
- 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
MedStar National Rehabilitation Hospital
MedStar Health is looking for an Occupational Therapist (Outpatient Neuro) to join our team at MHPT @ Irving Street -Neurorehab Center ! We are looking for professional competency as a general practitioner in occupational therapy, independent use of varied evaluation and treatment approaches, and the ability to work in a team environment.
The Occupational Therapist provides occupational therapy services to patients, to include but not limited to screening and evaluation, treatment planning, treatment implementation, treatment re-assessment and revision, patient/client re-evaluation, discharge planning, and documentation. The Occupational Therapist participates, as requested, in program planning and protocol development and assists the team in meeting established goals.
Join one of the largest healthcare systems in the Baltimore-Washington metro re gion, also recognized as one of the "Healthiest Maryland Businesses". Apply today and learn how MedStar Health can be your next great career move!
Primary Duties:
* Provides evaluation services including review of pertinent historical information, performance of specific assessments, and determination of recommendations and documentation of results. Explains evaluation findings and treatment plan to patient and family and incorporates patient and family in the goals setting.
* Demonstrates proficiency in implementation of treatment protocols based upon evaluation findings, the patient's presentation, and the evolving health care environment. Consults with other healthcare professionals as indicated. Recognizes and documents changes in patient's condition requiring modification of the plan of care and/or the need for medical/rehabilitation consultation.
* Completes appropriate discharge planning and follow-up care. Accurately and timely documents and charges for patient care activities considering our evolving health care environment, painting a clear picture of the patient's course of care including focused initial evaluation/plan of care that establishes baseline and goals, legible daily encounter notes, interim progress summaries, and discharge evaluation.
* Demonstrates effective time management and meets productivity expectations. Manage an accurate schedule. Demonstrates a professional commitment to provide frictionless patient access to care through flexibility, adaptability, creativity, and actions/behaviors that display empathy in our patient consumer driven environment.
* Takes initiative in pursuing and directing continuing education for professional growth and competency for self and organization. Serves as a clinical instructor to assign students. Assists with orientation and mentoring of inexperienced staff, students, volunteers, and technicians.
Qualifications:
* Bachelor's degree, Master's degree, or Doctoral degree in Occupational Therapy from an accredited school of Occupational Therapy.
* Maryland, District of Columbia (DC), and/or Virginia licensure required as deemed necessary for your specific location(s).
* and American Heart Association's BLS (Basic Life Support) for Healthcare Providers CPR (Cardiac Pulmonary Resuscitation) certification.
This position has a hiring range of : USD $74,214.00 - USD $134,596.00 /Yr.
Unit Highlights
Are you an experienced RN who enjoys variety in your workday? We are offering an exciting opportunity to join our Nursing Float Pool. This role is perfect for an RN who thrives on new challenges and enjoys the flexibility of working across multiple units within the organization. The unit include Medical, Surgical, Intermediate Care and Emergency Services. You’ll have the chance to expand your skills and experience while providing high-quality care within your competency level.
Available Opportunities: Full-time, 7:00am-7:00pm
Key Responsibilities
As a Clinical Nurse, you will provide skilled, compassionate care to patients and families across a spectrum of needs—from routine to highly complex. You will assess evolving patient conditions, identify actual and potential health concerns, and develop appropriate care plans. Interventions may be delivered directly or coordinated through collaboration with other members of the nursing team
Nursing Benefits
- Nationally recognized nurse wellbeing resources
- Comprehensive health benefit plans
- Generous paid time off and flex scheduling options
- Retirement plans with match
- Tuition assistance to advance your education
- Systemwide referral bonus program—up to $6,000 for each RN and up to $4,000 for each LPN that joins MedStar Health
- Relocation assistance up to $5,000
- Free parking for associates
Qualifications
- ADN, BSN, MSN, or CNL from an accredited School of Nursing required.
- Minimum two years of nursing experience in med/surg.
- Active MD RN License or Active Compact State RN and Basic Life Support for Healthcare providers required (AHA or American Red Cross).
Licensed Clinical Social Worker (LCSW)
Wage: Between $90-$127 an hour
Licensed Clinical Social Worker — Are you ready to launch or expand your private practice? Headway is here to help you start accepting insurance with ease, increase your earnings with higher rates, and start taking covered clients sooner. It's all on one free-to-use platform, no commitment required.
About you
● You're a fully-licensed Clinical Social Worker at a Master's level or above with LCSW, LICSW, or LCSCW licensure (accepted on a state by state basis), a valid NPI number, and malpractice insurance.
● You're ready to launch a private practice, or grow your existing business by taking insurance.
About Headway
Your expertise changes lives. Taking insurance makes it accessible to those who need it most. Every mental health provider who goes in-network with Headway supports people who'd otherwise be forced to choose between paying out of pocket, or not getting care at all. We make that process seamless — empowering you to accept insurance with ease, so you can do what you do best. So far, we've helped over 50,000 providers grow their practices, reaching countless people in need.
How Headway supports providers
- Start taking insurance, stress-free: Get credentialed for free in multiple states in as little as 30 days and start seeing covered clients sooner.
- Built-in compliance : Stay compliant from day one with audit support and ongoing resources.
- Expansive coverage: Work with the plans that most clients use, including Medicare Advantage and Medicaid.
- Increase your earnings: Secure higher rates with top insurance plans through access to our nationwide insurance network.
- Dependable payments: Build stability in your practice with predictable bi-weekly payments you can count on.
- Built-in EHR features : Manage your practice in one place with real-time scheduling, secure client messaging, end-to-end documentation templates, built-in assessments, and more.
- Free continuing education : Nurture your long-term professional goals and earn CEUs with complimentary courses on Headway Academy.
How Headway supports your clients
● Increased access: Headway makes it easier for your clients to get the care they need at a price they can afford through insurance.
● Instant verification: Clients can easily check their insurance status and get the care they need without disruption.
Please note: At this time, Headway can't support mental health professionals that aren't fully licensed. If your application was rejected for incomplete licensure, you're welcome to reapply once you have a valid license.
About Headway
We make it easy for mental health providers to take insurance by credentialing you with the nation's largest networks, handling billing and admin paperwork, and helping you earn more stable income with higher rates. With Headway, you can finally focus on what matters most: providing life-changing care. We'll take care of the rest.
Wage: Between $120-$131 an hour
Licensed Professional Counselor — Are you ready to launch or expand your private practice? Headway is here to help you start accepting insurance with ease, increase your earnings with higher rates, and start taking covered clients sooner. It's all on one free-to-use platform, no commitment required.
About you
● You're a fully-licensed Professional Counselor at a Master's level or above with LPC, LPCC, LCPC, LCPCS, LPCC-S licensure (accepted on a state by state basis), a valid NPI number, and malpractice insurance.
● You're ready to launch a private practice, or grow your existing business by taking insurance.
About Headway
Your expertise changes lives. Taking insurance makes it accessible to those who need it most. Every mental health provider who goes in-network with Headway supports people who'd otherwise be forced to choose between paying out of pocket, or not getting care at all. We make that process seamless — empowering you to accept insurance with ease, so you can do what you do best. So far, we've helped over 50,000 providers grow their practices, reaching countless people in need.
How Headway supports providers
- Start taking insurance, stress-free: Get credentialed for free in multiple states in as little as 30 days and start seeing covered clients sooner.
- Built-in compliance : Stay compliant from day one with audit support and ongoing resources.
- Expansive coverage: Work with the plans that most clients use, including Medicare Advantage and Medicaid.
- Increase your earnings: Secure higher rates with top insurance plans through access to our nationwide insurance network.
- Dependable payments: Build stability in your practice with predictable bi-weekly payments you can count on.
- Built-in EHR features : Manage your practice in one place with real-time scheduling, secure client messaging, end-to-end documentation templates, built-in assessments, and more.
- Free continuing education : Nurture your long-term professional goals and earn CEUs with complimentary courses on Headway Academy.
How Headway supports your clients
● Increased access: Headway makes it easier for your clients to get the care they need at a price they can afford through insurance.
● Instant verification: Clients can easily check their insurance status and get the care they need without disruption.
Please note: At this time, Headway can't support mental health professionals that aren't fully licensed. If your application was rejected for incomplete licensure, you're welcome to reapply once you have a valid license.
"
Wage: Between $120-$131 an hour
Licensed Mental Health Counselor — Are you ready to launch or expand your private practice? Headway is here to help you start accepting insurance with ease, increase your earnings with higher rates, and start taking covered clients sooner. It's all on one free-to-use platform, no commitment required.
About you
● You're a fully-licensed Mental Health Counselor at a Master's level or above with LMHC, LPCMH, or LIMHP licensure (accepted on a state by state basis), a valid NPI number, and malpractice insurance.
● You're ready to launch a private practice, or grow your existing business by taking insurance.
About Headway
Your expertise changes lives. Taking insurance makes it accessible to those who need it most. Every mental health provider who goes in-network with Headway supports people who'd otherwise be forced to choose between paying out of pocket, or not getting care at all. We make that process seamless — empowering you to accept insurance with ease, so you can do what you do best. So far, we've helped over 50,000 providers grow their practices, reaching countless people in need.
How Headway supports providers
- Start taking insurance, stress-free: Get credentialed for free in multiple states in as little as 30 days and start seeing covered clients sooner.
- Built-in compliance : Stay compliant from day one with audit support and ongoing resources.
- Expansive coverage: Work with the plans that most clients use, including Medicare Advantage and Medicaid.
- Increase your earnings: Secure higher rates with top insurance plans through access to our nationwide insurance network.
- Dependable payments: Build stability in your practice with predictable bi-weekly payments you can count on.
- Built-in EHR features : Manage your practice in one place with real-time scheduling, secure client messaging, end-to-end documentation templates, built-in assessments, and more.
- Free continuing education : Nurture your long-term professional goals and earn CEUs with complimentary courses on Headway Academy.
How Headway supports your clients
● Increased access: Headway makes it easier for your clients to get the care they need at a price they can afford through insurance.
● Instant verification: Clients can easily check their insurance status and get the care they need without disruption.
Please note: At this time, Headway can't support mental health professionals that aren't fully licensed. If your application was rejected for incomplete licensure, you're welcome to reapply once you have a valid license.
About Headway
We make it easy for mental health providers to take insurance by credentialing you with the nation's largest networks, handling billing and admin paperwork, and helping you earn more stable income with higher rates. With Headway, you can finally focus on what matters most: providing life-changing care. We'll take care of the rest.
Remote working/work at home options are available for this role.
Wage: Between $120-$131 an hour
Licensed Mental Health Counselor — Are you ready to launch or expand your private practice? Headway is here to help you start accepting insurance with ease, increase your earnings with higher rates, and start taking covered clients sooner. It's all on one free-to-use platform, no commitment required.
About you
● You're a fully-licensed Mental Health Counselor at a Master's level or above with LMHC, LPCMH, or LIMHP licensure (accepted on a state by state basis), a valid NPI number, and malpractice insurance.
● You're ready to launch a private practice, or grow your existing business by taking insurance.
About Headway
Your expertise changes lives. Taking insurance makes it accessible to those who need it most. Every mental health provider who goes in-network with Headway supports people who'd otherwise be forced to choose between paying out of pocket, or not getting care at all. We make that process seamless — empowering you to accept insurance with ease, so you can do what you do best. So far, we've helped over 50,000 providers grow their practices, reaching countless people in need.
How Headway supports providers
- Start taking insurance, stress-free: Get credentialed for free in multiple states in as little as 30 days and start seeing covered clients sooner.
- Built-in compliance : Stay compliant from day one with audit support and ongoing resources.
- Expansive coverage: Work with the plans that most clients use, including Medicare Advantage and Medicaid.
- Increase your earnings: Secure higher rates with top insurance plans through access to our nationwide insurance network.
- Dependable payments: Build stability in your practice with predictable bi-weekly payments you can count on.
- Built-in EHR features : Manage your practice in one place with real-time scheduling, secure client messaging, end-to-end documentation templates, built-in assessments, and more.
- Free continuing education : Nurture your long-term professional goals and earn CEUs with complimentary courses on Headway Academy.
How Headway supports your clients
● Increased access: Headway makes it easier for your clients to get the care they need at a price they can afford through insurance.
● Instant verification: Clients can easily check their insurance status and get the care they need without disruption.
Please note: At this time, Headway can't support mental health professionals that aren't fully licensed. If your application was rejected for incomplete licensure, you're welcome to reapply once you have a valid license.
About Headway
We make it easy for mental health providers to take insurance by credentialing you with the nation's largest networks, handling billing and admin paperwork, and helping you earn more stable income with higher rates. With Headway, you can finally focus on what matters most: providing life-changing care. We'll take care of the rest.
Wage: Between $120-$131 an hour
Licensed Professional Counselor — Are you ready to launch or expand your private practice? Headway is here to help you start accepting insurance with ease, increase your earnings with higher rates, and start taking covered clients sooner. It's all on one free-to-use platform, no commitment required.
About you
● You're a fully-licensed Professional Counselor at a Master's level or above with LPC, LPCC, LCPC, LCPCS, LPCC-S licensure (accepted on a state by state basis), a valid NPI number, and malpractice insurance.
● You're ready to launch a private practice, or grow your existing business by taking insurance.
About Headway
Your expertise changes lives. Taking insurance makes it accessible to those who need it most. Every mental health provider who goes in-network with Headway supports people who'd otherwise be forced to choose between paying out of pocket, or not getting care at all. We make that process seamless — empowering you to accept insurance with ease, so you can do what you do best. So far, we've helped over 50,000 providers grow their practices, reaching countless people in need.
How Headway supports providers
- Start taking insurance, stress-free: Get credentialed for free in multiple states in as little as 30 days and start seeing covered clients sooner.
- Built-in compliance : Stay compliant from day one with audit support and ongoing resources.
- Expansive coverage: Work with the plans that most clients use, including Medicare Advantage and Medicaid.
- Increase your earnings: Secure higher rates with top insurance plans through access to our nationwide insurance network.
- Dependable payments: Build stability in your practice with predictable bi-weekly payments you can count on.
- Built-in EHR features : Manage your practice in one place with real-time scheduling, secure client messaging, end-to-end documentation templates, built-in assessments, and more.
- Free continuing education : Nurture your long-term professional goals and earn CEUs with complimentary courses on Headway Academy.
How Headway supports your clients
● Increased access: Headway makes it easier for your clients to get the care they need at a price they can afford through insurance.
● Instant verification: Clients can easily check their insurance status and get the care they need without disruption.
Please note: At this time, Headway can't support mental health professionals that aren't fully licensed. If your application was rejected for incomplete licensure, you're welcome to reapply once you have a valid license.
"
Wage: Between $120-$131 an hour
Licensed Professional Counselor — Are you ready to launch or expand your private practice? Headway is here to help you start accepting insurance with ease, increase your earnings with higher rates, and start taking covered clients sooner. It's all on one free-to-use platform, no commitment required.
About you
● You're a fully-licensed Professional Counselor at a Master's level or above with LPC, LPCC, LCPC, LCPCS, LPCC-S licensure (accepted on a state by state basis), a valid NPI number, and malpractice insurance.
● You're ready to launch a private practice, or grow your existing business by taking insurance.
About Headway
Your expertise changes lives. Taking insurance makes it accessible to those who need it most. Every mental health provider who goes in-network with Headway supports people who'd otherwise be forced to choose between paying out of pocket, or not getting care at all. We make that process seamless — empowering you to accept insurance with ease, so you can do what you do best. So far, we've helped over 50,000 providers grow their practices, reaching countless people in need.
How Headway supports providers
- Start taking insurance, stress-free: Get credentialed for free in multiple states in as little as 30 days and start seeing covered clients sooner.
- Built-in compliance : Stay compliant from day one with audit support and ongoing resources.
- Expansive coverage: Work with the plans that most clients use, including Medicare Advantage and Medicaid.
- Increase your earnings: Secure higher rates with top insurance plans through access to our nationwide insurance network.
- Dependable payments: Build stability in your practice with predictable bi-weekly payments you can count on.
- Built-in EHR features : Manage your practice in one place with real-time scheduling, secure client messaging, end-to-end documentation templates, built-in assessments, and more.
- Free continuing education : Nurture your long-term professional goals and earn CEUs with complimentary courses on Headway Academy.
How Headway supports your clients
● Increased access: Headway makes it easier for your clients to get the care they need at a price they can afford through insurance.
● Instant verification: Clients can easily check their insurance status and get the care they need without disruption.
Please note: At this time, Headway can't support mental health professionals that aren't fully licensed. If your application was rejected for incomplete licensure, you're welcome to reapply once you have a valid license.
"