Clinical Protocol Coordinator

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

Responsibilities

• Assist Principal Investigators in the planning, development, and implementation of clinical protocols for evaluation of VRC investigational vaccine and monoclonal antibody products.
• Ensure that clinical research protocols, consent forms, Investigator Brochures and other clinical research documents are in compliance with applicable regulatory requirements defined by the Code of Federal Regulations (CFR) and Good Clinical Practice guidelines.
• Ensure that data collection plans are consistent with applicable regulatory requirements and the protocol objectives.
• Assist in protocol training, study implementation, site management and reporting of study outcomes.
• Design, write and develop documents related to the use of investigational products, including but not limited to: conducting background research, reviewing and interpreting scientific and technical information, technical writing, ensuring compliance with regulatory requirements, and preparing or editing scientific summaries, presentations and publications.
• Prepare and review regulatory submissions, annual reports, IND safety reports, human subjects experience sections for investigator brochures and other supporting documents for vaccine and other related product types.
• Manage protocol and trial development by working and coordinating with clinical research teams that include physicians, laboratory scientists, research nurses, pharmacists, regulatory personnel, and support staff.
• Ensure that advice and actions of VRC staff are consistent with Institute, NIH, and DHHS goals and policies, as well as with applicable statutes, regulations, rules, and directives.
• Manage clinical trial activities and communications with study team member throughout the protocol life cycle.
• Use information technology/telecommunication systems for data management and document control, support the dissemination of information on vaccine, monoclonal antibody and other VRC clinical trials and coordinate response to related inquiries from sites, sponsors, FDA, and other regulatory agencies.
• Assist with quality management activities for the CTP by reviewing and developing policies and procedures and provide support to risk assessment and clinical monitoring activities. Design and conduct assessments of quality management and regulatory performance with respect to the achievement of program goals and objectives. Prepare, plan, and recommend any identified necessary changes.
• Other duties as assigned.

Qualifications

• Master’s degree in Life Sciences or related discipline. Two years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
• Two years of experience in a related field. Expertise in the fundamentals of clinical trials. Experience in clinical data management, database operations and analysis. Familiarity with IRB requirements.
• Experience in clinical trials development and management.
• Knowledge of the biological or health sciences gained through advanced education or equivalent training is required.
• Health-related, clinical research or clinical care experience as well as broad knowledge of the procedures and policies related to clinical trials research is required.
• Knowledge of and the ability to design human clinical trials protocols and the analytical skills to identify and resolve potential problems related to clinical research and regulatory activities or requirements is required