Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Trial Program located in Bethesda, MD.
Technical Requirements
•Manage Trial Master File (TMF) activities for all CTP trials. Develop protocol-specific TMF indexes and plans at trial start, collection and file TMF documents throughout the trial, collaborate with TMF CRO support during and after the trial, and ensure QC of final TMF at the end of the trial.
•Develop processes and SOPs and other documents to support TMF management.
•Ensure adherence to processes and SOPs specific to documents under their management.
•Ensure documents are readily available for audits and inspections.
•Participate in internal or external audits and regulatory authority inspections as needed.
•Participate in NIAID and VRC working groups as a subject matter expert on TMF activities/needs and evaluation of TMF storage platforms/tools.
•Provide guidance and serve as a TMF resource to colleagues. Draft, edit, and review protocols and operations manuals specific to the research projects.
•Serve as a liaison to the VRC Regulatory Science and Strategy Program, VRC leadership and external collaborators on regulatory-related topics/projects.
•Review and provide input on various research agreements (interagency agreements, clinical trial agreements, etc.) to ensure the program’s needs are met.
•Review documents (monitoring reports, audit reports, etc.) to ensure site or CRO compliance with federal regulations, GCP, ICH guidelines and other regulatory requirements.
•Provide guidance on international regulations and requirements for CTP trails/activities conducted outside the US.
Specific Qualifications
•MS/BS with applicable job experience may be considered. Regulatory Affairs Certification (RAC) preferred.
•Experience in the pharmaceutical/biotechnology industry, government, or equivalent, including clinical document management system experience, preferably with drugs or biologics products.
•Experience participating in internal or external audits and regulatory authority inspections preferred.
•Demonstrates knowledge and understanding of GCP, ICH guidelines and, regulatory requirements for clinical research and TMFs.