Clinical Studies Data And Safety Advisor SME
Clinical Studies Data And Safety Advisor SME
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Salary Not Disclosed
1 Vacancy
Job Description
PartTime Physician Advisor Data and Safety Monitoring
Location: Bethesda MD
Hours: PartTime (Less than 30 hours per week)
Position Overview
We are seeking a licensed physician (or boardeligible candidate) to serve as an expert advisor for a comprehensive health program focused on research within primary care. This role involves organizing and facilitating Data and Safety Monitoring Boards (DSMB) and Observational Study Monitoring Boards (OSMB) ensuring adherence to ethical guidelines for protecting human subjects and providing clinical and regulatory expertise throughout the research lifecycle.
Key Responsibilities:
- Organize and oversee the infrastructure for DSMB/OSMB meetings and monitoring clinical trials.
- Identify and secure appropriate members for DSMB/OSMB and provide guidance on monitoring plans.
- Develop and draft requirements for establishing a single Institutional Review Board (IRB).
- Monitor clinical trials for safety evaluate adverse events and provide guidance on study termination decisions.
- Collaborate with staff and investigators on clinical protocol design implementation and review.
- Write policies and guidelines impacting patient safety and research studies.
- Prepare detailed reports and recommendations for clinical oversight and safety.
- Participate in site visits and serve as a subject matter expert on safety and clinical processes.
Qualifications:
- Medical degree with a valid license or board eligibility.
- Expertise in clinical trial oversight protocol review and human research protections.
- Strong background in clinical research safety monitoring and regulatory compliance.
- Excellent risk management analytical and communication skills.
Preferred Skills:
- Experience with DSMBs OSMBs and IRBs.
- Proficiency in Outlook and other office tools.
- Background in developing and implementing research and safety training programs.
This is a rewarding opportunity to contribute to impactful research while ensuring the safety and wellbeing of study participants.
Apply Now! If you are passionate about clinical research and have the expertise to oversee data and safety processes wed love to hear from you
Employment Type
Full Time
