Job ID: 289509378  |  Last Updated: 9/20/2017

Medical Officer

Medical Science & Computing
Rockville, MD
Applicant Contact
Elisa Johnston
(301) 357-0140
Accepts J-1 Visas

Job Description

Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

Medical Science & Computing is searching for a Medical Officer to provide support for the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.

Duties and Responsibilities:

Manage clinical protocols by assembling and training the study team; overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.
Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
Independently assess acute and non-acute clinical and research related problems and toxicities.
Assist the Principal Investigator in developing clinical protocols including the evaluation of feasibility and budget.
Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
Supervise, mentor and train new or junior research staff.
Develop and maintain study subject databases; supervise data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.
Supervise and coordinate the collection, processing, shipment and storage of biospecimens.
Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.

Position Requirements:

Masters of Science Degree in Nursing or Physician Assistant Studies (MPAS), Health Science (MHS) or Medical Science (MMSc) with a Minimum of two (2) years of experience in Healthcare, Biomedical or Clinical Research, or Public Health.
Current Licensure and/or Certification to practice as a Nurse Practitioner, or Physician Assistant, or equivalent in the state of Maryland.
Exceptional organizational development skills
Detailed knowledge of project planning, tracking, resource management, operational risk assessment, and vaccine program analyses highly preferred
Excellent analytical and writing skills to edit or prepare a variety of responses, meeting materials, technical and administrative correspondence and reports
Expertise in effective verbal and written communications
Strong leadership skills with demonstrated ability to drive positive results.
Basic knowledge of applicable laws and regulations that regulate clinical trials
Prior experience with Clinical Research
Well versed in all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation with IRB and FDA
Excellent interpersonal skills
NIH Clinical Center experience a plus

Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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