Protocol Navigator - NIH

Overview

Come join a company that strives for Extraordinary People and Exceptional Performance!  Chenega Services and Federal Solutions (CSFS) is seeking a Protocol Navigator to provide support services to the National Institutes of Health (NIH) Clinical Center. 

Our company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunities. We actively strive to channel our highly engaged employee’s knowledge, critical thinking, innovative solutions for our clients.

Work Location:

• Onsite-9000 Rockville Pike Bethesda, Maryland 20892 United States

Responsibilities

• Assist Principal Investigators (PI) with development of clinical research protocols, informed consent forms (ICFs), and other study documents by completing standard wording for regulatory sections as well as reviewing / revising other sections of documents for consistency.
• Format documents.
• Ensure consistency within protocol and between protocol and ICF.
• Maintain proper and consistent communication with PIs/research teams by attending regular study/team meetings or calls to stay on track of development of study documents.
• Distribute appropriate forms for PI, Peer Reviewers and Branch Chiefs.
• Assist PIs in incorporating suggested changes and respond to reviewers’ comments.
• Collecting all forms and PI responses to prepare a Branch Review packet.
• Prepare new submissions for Ancillary Review and IRB committees.
• Prepare periodic submissions to Ancillary Review Committees.
• Manage completion of Resource Assessment Forms (PRIA), Travel Reimbursement Forms (DRTS), Ethics Clearance submissions (DEC) and Radiation Safety Committee submission (RSC) (when applicable).
• Respond to OPS (Office of protocol Service) Protrak requests.
• Assist with submitting requests for Recruitment Flyers and collaborate with Office of Recruitment for the development materials.
• 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 IRB and ORSC Policies and SOPs.
• Support interactions with FDA Regulatory Managers (when applicable).
• Assist in responding to stipulations (when applicable).
• Assist with preparing and submitting materials for Annual and Quadrennial Scientific review submissions.
• Assist with Reliance Agreement requests and submissions.
• Coordinate translations of consents as needed.
• Assist research team with monitoring visits regarding the regulatory binder.
• Act and liaison and main Point of Contact between IRB, sponsor, and other sites.
• Proactively participate in the peer review process and utilize the systems for tracking, management and storage of documents and tasks.
• Be flexible and agile shifting priorities in supporting research teams.

• Other duties as assigned

Qualifications

Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)

•  Minimum of an B.S. degree in a related field.

Knowledge, Skills and Abilities:

• Ability to read, write, and speak English well enough to effectively communicate with all parties.
• Computer literate.
• Possess sufficient initiative, interpersonal relationship skills and social sensitivity to enable relating constructively to a variety of patients from diverse backgrounds.

Please note that qualified candidates will be requested to complete a writing assessment which will be provided at a later time.