Medical Science & Computing (MSC), is 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 Bethesda, Maryland.
Duties & Responsibilities
- Provide patient care and clinical operational support to clinical research trials as part of the Institute's clinical research program.
- Perform protocol-mandated initial and follow-up medical histories and physical examinations as per the protocol.
- Review in real-time all laboratory and relevant clinical reports.
- Implement appropriate medical interventions for significant findings found during study participant evaluations.
- In collaboration with the Protocol Principal Investigator(s) ensure that all study participants have appropriate emergency medical access in the event of study related illness.
- Assist and provide clinical guidance to members of the clinical staff, particularly clinic nurses.
- Report all significant medical events in study participants appropriately, such as to the Principal Investigator(s) (PI) and Endpoint Review Committee.
- Plan and coordinate the initiation of each research study protocol, and the establishment of operating policies and procedures.
- Plan, implement, and maintain data collection and analysis systems in support of each research protocol; may coordinate the collection and analysis of research data.
- Ensure the smooth and efficient day-to-day operation of research and data collection activities; act as the primary operational point of contact for internal research staff.
- Coordinate the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
- Plan and coordinate the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity and also supervises and coordinates the provision of support services to investigators and researchers.
- Monitor the progress of research activities; develop and maintain records of research activities and prepare reports as required by investigators, administrators, funding agencies, and regulatory bodies.
- Write and review technical protocols and reports documenting analytical development studies pertaining to his/her work.
- Organize primary clinical trials data.
- Serve as member on NIH and external committees and boards as appropriate. Assist in publishing clinical research findings.
- Present research findings publicly as appropriate (domestically and internationally) according to the study policy and procedures for presentations.
- Understand the navigation of regulatory pathways in clinical trial site locations.
- Organize training and participate in training of clinical site staff (protocol training, administration, lab assays).
- Oversee clinical trial operations and advise site PIs related to recruitment, community relations, eligibility, enrollment, adverse event management, and product questions.
- Implement quality control processes throughout the conduct of the trial and participate in clinical activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities and perform miscellaneous job- related duties as assigned/ required by the Project.
- Participate in the Quality Assurance/Quality Control processes.
- Medical Degree is required.
- Minimum of five (5) years of relevant experience in clinical research.
- Experience with viral vaccines and/or therapeutic product development.
- Strong relationship building, communications and management skills.
- Experience managing projects.
- Strong oral and technical writing capability.
- Demonstrated attention to detail.
- Demonstrated ability to work both independently and in a team-oriented, collaborative environment.
- Can conform to shifting priorities, demands and timelines.
- Demonstrate proper education, training and experience to conduct the clinical investigation.
- Has knowledge and experience in clinical decision-making in infectious disease medicine.
- Able to communicate effectively with all levels of clinical staff, render recommendations and policy interpretation, independently identify problems and effectively offer solutions.
- Frequent interaction between Federal and other contract staff, and sites interested in, or engaged in ACTIV3 or other NIAID COVID-19 clinical trials is required. Interactions include activities that require continuity, a high level of collaborative problem solving, and time- sensitive decision making.
- Handling of proprietary information in the strictest confidence is required and shall be bound by the same terms as the Government in this respect.
- Representation at all required conference/video calls is required as a critical communication platform for all aspects of the program.
- Fluent in English; Spanish and other languages are a plus.
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The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you'll get...
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program, and membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.