Clinical Research Coordinator Jobs

We are seeking a Clinical Research Coordinator to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in support of the overall functions of the DAIT Quality Assurance, Office of Regulatory Affairs.

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.  

• Upload documents and input key information (such as agreement status, program, drug information) into the Clinical Trial Agreement Livelink database.
• Assist in the management of Division contract records. Tasks include the following:
• Coordinate the development of various QA related metric reports.
• Provide document management (document control) support. Includes participation in the development of organized system tools for tracking specific clinical trial documentation received and by DAIT quality assurance.
• Participate in quality assurance activities related to the close out of DAIT projects (such as file audits, tracking, reconciliation, and transfer of clinical documents into long term archival facility).
• Support the DAIT Quality Assurance Manager, DAIT ORA in the development and implementation of the Division’s electronic Clinical Quality Management System (Master Control).
• Provide administrative support to the COR (Contact Officer Representative) who is responsible for management of the DAIT Regulatory Management Center (RMC) Contract in ensuring compliance with requirements of the contract (e.g., reviewing quarterly progress reports and other deliverables).
• Attend and assist in the planning and facilitation of Office of Regulatory Affairs team meetings.
• Generate contracts (clinical trials agreements, confidentiality agreements, etc.) tracking numbers and templates from the database to provide to staff.
• Reconcile information stored in the database with corresponding hard copy records.
• Facilitate working groups to collaborate and write project specific SOPs, work instructions and other documents to develop and harmonize operational processes. Identify new processes, build teams, lead working group meetings, develop and negotiate ideas from concept to written approved process.
• Perform quality assurance review of Office of Regulatory Affairs documents to include (but not limited to) contract agreements, audit reports, and other related clinical documents.
• Generate metric reports (from database) related to the contract agreements tracked in the database.
• Provide status updates to team members regarding agreement status and disposition.

• Excellent communication, grammar and writing skills required.
• Knowledge of clinical quality management and systems (such as Veeva, Master Control, etc.) is preferred.
• Demonstrated experience with Microsoft Office (Word, Excel, etc.).
• Bachelor’s degree in a related discipline.
• Demonstrated superior experience with data collection.
• Demonstrated superior knowledge of research protocols and clinical, scientific and/or medical terminology.
• Minimum of five (5) years of experience in clinical research or a related field.

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.