Protocol Navigator

Responsibilities

• Aid Principal Investigators (PI) in developing clinical research protocols, informed consent forms (ICFs), and other study documents.
• Complete standard wording for regulatory sections and review/review other sections for consistency.
• Format documents and ensure consistency within the protocol and ICF.
• Maintain communication with PIs/research teams through regular meetings or calls.
• Distribute necessary forms to PI, Peer Reviewers, and Branch Chiefs.
• Aid PIs in incorporating suggested changes and addressing reviewer comments.
• Collect and prepare Branch Review packets.
• Prepare submissions for Ancillary Review and IRB committees.
• Manage completion of Resource Assessment Forms (PRIA), Travel Reimbursement Forms (DRTS), Ethics Clearance submissions (DEC), and Radiation Safety Committee submissions (RSC).
• Respond to OPS (Office of Protocol Service) Protrak requests.
• Aid in the preparation and submission of Recruitment Flyers.
• Support the preparation and submission of continuing reviews, protocol amendments, and various IRB submissions.
• Maintain a Regulatory Binder and update Protocol View.
• Stay informed about IRB and ORSC Policies and SOPs.
• Assist with FDA Regulatory Manager interactions (when applicable).
• Respond to stipulations (when applicable).
• Aid in the preparation and submission of materials for Annual and Quadrennial Scientific review submissions.
• Assist with Reliance Agreement requests and submissions.
• Coordinate translations of consents as needed.
• Support monitoring visits involving the regulatory binder.
• Act as the main point of contact between IRB, sponsor, and other sites.

Qualifications

• Minimum of a B.S. degree in a related field.
• Knowledge, skills, and abilities including reading, writing, and speaking English well, computer literacy, initiative, interpersonal relationship skills, and social sensitivity.