1+ months

Protocol Navigator

MSC
Bethesda, MD 20814

Overview

We blend deep domain expertise in health IT, life sciences, public safety, and grants management with advanced technologies to help Federal agencies solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to cultivate a culture of innovation, customer success, and employee growth.

Duties & 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
  • Format documents
  • Ensure consistency within protocol and between protocol and ICF.

Branch Review

  • 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
  • Resource Assessment Form (PRIA)
  • Travel Reimbursement Form (DRTS)
  • Ethics Clearance submission (DEC)
  • Radiation Safety Committee submission (RSC) (when applicable)
  • Recruitment Flyers
  • 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

Regulatory Services

  • 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)

DSMB reports

  • 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

 Other tasks

  • 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.

Requirements

  • 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
  • Prior NIH experience preferred
  • Prior FDA experience preferred

Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Categories

Posted: 2020-08-04 Expires: 2020-10-08

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Protocol Navigator

MSC
Bethesda, MD 20814

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