MSC is currently searching for a Protocol Navigator to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD.
Duties and Responsibilities:
Initial Protocol/Consent Writing/Editing
Assist Principal Investigators (PI) with the writing/revision of clinical research protocols and informed consent forms (ICFs); completing standard wording for regulatory sections in new protocols using template language
Ensure consistency within protocol and between protocol and ICF.
Assist PIs with scheduling meeting and with distribution of documents prior to meeting.
Distribute appropriate forms for PI, Peer Reviewers. And Branch Chiefs to complete
Assist PIs in incorporating suggested changes and respond to reviewers’ comments.
Collecting all forms and PI responses to prepare a Branch Review packet.
IRB actions and Protocol Administration
Prepare new protocol for Scientific Review and IRB submission
Prepare and submit continuing reviews (with assistance of research team and data managers), protocol amendments, various other IRB submissions in consultation with PI
Maintain Regulatory Binder
Update Protocol View
Keep up with current regulations/guidance
Facilitate Pre-IND/IDE meetings (when applicable)
Prepare Initial IND/IDE Submission
Facilitate interactions with FDA Regulatory Managers (when applicable).
Prepare FDA annual reports and other submissions with assistance of research team and data managers (when applicable)
Draft reports with assistance of research team and Data Managers (when applicable)
Submit all docs prior to meeting
Assist in responding to stipulations (when applicable)
Radiation Safety Committee (RSC) Actions
Prepare initial submission
Prepare triennial review submission
Assist with MTA agreements
Assist with Reliance Agreement requests and submissions
Coordinate translations of consents and tracking number of short forms used.
Assist research team with monitoring visits in regards to the regulatory binder.
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.
BS degree in Biomedical Sciences or related discipline; MS or MPH preferred
Demonstrated experience coordinating all aspects of clinical research
Experience writing and reviewing protocols, managing IRB submissions, database management, monitoring study records
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.