Clinical Research Coordinator

Overview

We are seeking a Clinical Research 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

• As a member of the Protocol Operations team, develop clinical research protocols and informed consents for evaluation of investigational vaccines and monoclonal antibodies, including but not limited to the following tasks: conduct background research on infectious diseases targets and any already developed, related countermeasures; review and interpret scientific data and technical information to include in the protocol as background and rationale; take on the primary responsibility of drafting the protocol and informed consent documents in close collaboration with the trial principal investigator (PI) and other members of the clinical research team; ensure compliance with regulatory requirements for clinical research and adherence to established protocol development timelines.
• Distribute protocol and study documents to VRC personnel, scientific collaborators, and contractors from Clinical Research Organizations (CROs) per the work instructions of the Protocol Operations team.
• Draft protocol amendments, continuing reviews, and other protocol-related documents in close collaboration with the study PI, and with other clinical research team members, that are submitted to the IRB or FDA and facilitate review of these documents by the clinical research team.
• Assist the clinical research team with responses to stipulations from the IRB.
• Assist the clinical research team with responses to any correspondence and questions from the FDA related to clinical protocols.
• Collaborate with staff of the VRC Regulatory Science and Strategy Program (RSSP) by contributing to the clinical research sections of investigational new drugs (IND) applications, investigational brochures, IND annual reports, and any other submissions to FDA requiring clinical research input.
• Ensure that protocol-related data collection plan documents are consistent with regulatory requirements and the protocol objectives.
• Gather, interpret, summarize, and/or graph clinical research data included in protocols, IND applications, IND annual reports, investigator brochures or that are submitted for reporting to clinicaltrials.gov.
• Assist with tracking the workflow of the Protocol Operations team to ensure timely development, completion, and submission of protocols and of all protocol-related documents.
• Assist in processes for quality assurance and quality control of protocol and protocol- related documents, including at the time of their submission to the IRB.
• Develop, update, and review work instructions (WIs) and standard operating procedures (SOPs) for the Protocol Operations team and implement contributions to and review of these documents by other team members of the Protocol Operations team.
• Contribute to the development of Data Collection Forms (DCFs), electronic case report forms (eCRFs), and Reliance Agreements
• Practice and facilitate adherence to SOPs, Good Clinical Practice (GCP), and Food and Drug Administration (FDA) regulations.
• Demonstrate strong communication and collaboration skills with the Protocol Operations team and with other teams in the CTP or outside of the CTP.

Qualifications

• Ph.D. and/or M.D. with at least one year of experience in clinical research or in a related field. Master’s degree with at least 3 years of experience in clinical research or in a related field.
• Prior experience managing a team preferred.
• Experience submitting documents to IRB or