Clinical Research Coordinator - CAMRIS

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

• Provide project management for the day-to-day DAIDS protocol registration (PR) activities including but not limited to, coordinating and leading meetings, and discussions regarding all aspects of protocol registration.
• Serve as point of contact for all protocol registration activities for DAIDS.
• Serve as the primary reviewer of all protocol registration deliverables including but not limited to standard PR reports, PR notification messages, review and recommend approval to Federal Client of all Investigator or Records, and Clinical Research Site regulatory documentation that include IRB/EC documentation, Forms FDA 1572/DAIDS IoR Forms, and site-specific informed consent forms to ensure all applicable regulations are met.
• Serve as the co-lead for working groups and committees to communicate information regarding protocol registration policies and requirements.
• Manage and design all protocol registration related trainings for DAIDS, including but not limited to e-training modules and present proposals/materials to the PR Team Leader for approval prior to implementation.
• Evaluate and identify issues that are or may be problematic related to protocol registration and recommend policy and procedural changes to improve operations to the DAIDS PR Team Leader prior to implementation.
• Serve as the primary PR Team reviewer of protocol registration-related reports and documents from contractors (SOPs, quarterly and annual progress reports, timelines, procedure changes, etc.).
• Coordinate and provide project management for the continued development of the DAIDS Protocol Registration System (DPRS) module in the DAIDS ES.
• Provide guidance, consultation and expert advice on regulations, policies and procedures to DAIDS staff and researchers and to domestic and international research organizations involved in DAIDS-sponsored research.
• Analyze and interpret regulations, policies and procedures and provide oral and written explanations and recommendations.
• Establish quality assurance standards and metrics for PR policies and procedures.
• Coordinate and communicate with other DAIDS, NIAID and NIH counterparts to ensure consistency and harmonization of regulatory procedures and strategies.
• Advise the PR Team Leader and DAIDS leadership on compliance with regulations, policies and procedures related to protocol registration. 

Qualifications

• Master’s degree in a related field is required.
• Minimum of 3-5 years of experience in clinical research operations is required.

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.