We are currently searching for a Medical Officer to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.
Duties & Responsibilities
- Evaluate existing protocols and provide suggestions for design, execution and improvement.
- Provide guidance to staff on various clinical processes and operational issues.
- Reviews safety reports and provides assessment of clinical implications of findings.
- Develop policies and guidelines.
- Coordinate and participate in various meetings, training and safety-related educational programs.
- Perform Medical Review Activities including:
- Study documents: participate in drafting protocols and ICFs, draft shell tables, training materials, monitoring reports for clinical aspects and adherence to protocol.
- Clinical data: tables, listings, figures, narratives, draft reports, summaries of efficacy, safety, benefit risk, regulatory responses, publications, press releases.
- Compliance: review responses to audit findings, protocol deviations and violations; draft and review SOPs.
- Draft and review position papers: on disease under study, competitive intelligence on ongoing studies and therapies, literature searches.
- Perform Team Activities (lead or participate, as needed) including:
- Protocol meetings
- Organizational and team building activities
- Training on clinical and safety components of protocol
- Presentations on strategy, protocol, data, and progress to team(s), management, study sites
- Define/clarify roles and responsibilities, review enrollment strategies, country and site selection, speed of activation, site training, assessment of non-enrolling sites, scrutiny of high enrolling sites
- Involvement in Strategy and Organization including:
- Regulatory: strategy, submissions, writing, document review, responses
- Communications: assist in creation/management of clinical website, media materials, press releases, communications to study staff
- Clinical liaison for studies with other divisions and programs
- General: coordination and chairing of workshops, expert meetings.
- Developing future strategic plans and educational materials for staff.
- Medical degree in a related field, required.
- Minimum eight (8) years of experience; inclusive of clinical trials and working with infectious diseases.
- Experience working with clinical protocols and safety components.
- Experience performing medical reviews; drafting protocols & reports.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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