Clinical Protocol Coordinator - CAMRIS

Overview

We are seeking a Clinical Protocol Coordinator to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. 

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.  

Responsibilities

• Prepare regulatory submissions for approval to initiate clinical studies of investigational vaccines and monoclonal antibodies targeting HIV and emerging infectious diseases.
• Conduct quality control reviews of IRB applications and all forms and documents included in the submission packets.
• Ensure that advice and actions of VRC/CTP staff are consistent with NIAID, NIH, and DHHS goals and policy, as well as with applicable statutes, regulations, rules, guidance and directives of the NIH IRB.
• Use information technology/telecommunication systems for document management and document control.
• Work in conjunction with the research nurse / study coordinator and the monitoring staff to schedule and attend monitoring visits for VRC protocols and to resolve and address findings generated during the visit.
• Prepare regulatory files for monitoring activities and interface with site monitors who conduct reviews of VRC regulatory files.
• Maintain the electronic and paper regulatory binders for the VRC clinical studies.
• Responsible for the administration, coordination, and management of the CTP activities related to the NIH Institutional Review Board (IRB) and the IRB’s management systems PROTECT and PROTRAK (PQS).
• Analyze and interpret regulations, policies and procedures and provide oral and written explanations and advice.
• Assist in ensuring that all VRC/CTP scientists and clinicians involved in human subject research are educated in policies and procedures governing such research.
• Create, distribute, and track all IRB submissions in support of the VRC clinical trials activities. Logs all items in the tracking software used by VRC.
• Distribute IRB memoranda to Principal Investigator and other appropriate CTP staff as needed. Provide input on timelines and plans for VRC activities related to regulatory reviews.
• Review investigators responses to IRB stipulations for completeness and make recommendations regarding the adequacy of the response.
• Design and modify forms, letters, and memoranda to guide initial and continuing review of protocols, to maintain efficient operations within the CTP, and to avoid delay or impediment to VRC clinical research. Monitor the flow of documents in and out of the office in conformance with strict deadlines of the NIH IRB.
• Track studies and communicate with investigators concerning the status and requirements for continuing reviews.
• Serve as a resource concerning procedures and regulations for initial IRB submission and continuing review of clinical protocols. Inform potential investigators and advise them of the documentation and approvals they need to initiate a clinical study, based on the type, location, and complexity of the protocol.
• Attend meetings of the CTP as well as the meetings related to the NIH IRB and work with clinical and regulatory staff to update work instructions and procedures as needed.
• Maintain current knowledge of policies and regulations from the DHHS, FDA, OHRP, HSR, NIAID, and NIH for the implementation of clinical studies.
• Provide input to the development and updating of CTP protocol manuals that are used as a reference for the conduct of external clinical trials.
• Interpret, synthesize, and clarify relevant changes or proposals in NIH or VRC regulatory policy or procedures and standing policies.
• Contribute to oversite process for all the required trainings for CTP staff members as well as required medical licenses, Curricula Vitae and trainings for the clinical staff.

Qualifications

• Master’s degree in Life Sciences or other related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a master’s degree.
• Minimum of two (2) years of experience in related field. Expertise in the fundamentals of clinical trials.
• Experience in clinical data and regulatory management and monitoring for clinical studies. Active knowledge of current regulatory and IRB requirements.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.