Clinical Protocol Coordinator

Overview:
We are seeking a Clinical Protocol Coordinator to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in 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:

• 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 otherVRC 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.

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.
• Excellent oral and written communication skills, technical writing skills and organizational skills as applied to scientific and clinical teams engaged in the development of new investigational vaccines, monoclonal antibodies or related product types.
• Ability to review, collect, assess and summarize scientific and other complex date and information related to the development of investigational products.
• Knowledge of skilled in the use of personal computers and software programs such as MS Word, Clinical Data Management Systems (DCSM), medical publication databases, document control systems and other information systems that support clinical research.

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

• 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 otherVRC 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