Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Medical Officer to join our vibrant team at Rockville, MD.
- Provide patient care and clinical operational support to clinical research trials as part of the NIAID DCR 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; supervise and coordinate 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.
Experience Required / Requirements
- 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.
- 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 NIAID 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.
- Travel will be required, as much as 75% of the time across the United States and US Territories; length of travel: two weeks up to perhaps a month; depending on the need at the clinical site.
- Travel domestically among the 60 clinical sites in one year.
- Paid Time Off (PTO)
- 10 Paid Federal holidays
- Generous health coverage provided with no monthly premium to the employee
- Generous vision and dental coverage provided with no monthly premium to the employee
- Short and Long-Term Disability coverage (paid by company)
- Basic Life and AD&D coverage (paid by company; option to purchase additional coverage)
- 401(K) with significant company match & no vesting period
- Competitive salaries with performance bonus opportunities
- Discount plan for pet care, legal services, & identify theft protection
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.