Overview

We are seeking a Clinical Program Manager 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

• Support the VRC CTP’s Quality Management Program under leadership of the Quality Program Manager, to ensure quality throughout all stages of the clinical trial process.
• Plan and conduct GCP sponsor audits (international and domestic) of clinical sites, contract clinical laboratories, and CROs to verify and document compliance status and identify any compliance risks.
• Assess GCP compliance risk areas and develop and implement risk mitigation measures.
• Ensure staff and program compliance with CTP’s quality procedures and regulatory requirements.
• Conduct trial master file audits.
• Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
• Serve on NIAID-wide working groups in support of NIAID’s broader development and implementation of a QMS.
• Provide support to federal clients in their evaluation and selection of CROs and other clinical and nonclinical service providers supporting CTP activities.
• Provide guidance, interpretation and information on GCP-related regulations, standards, and quality systems.
• Develop and implement SOPs, policies, work instructions, and other controlled documents for GCP regulatory compliance.
• Proactively identify areas for improvement, collaborate with QA and GCP staff and seek appropriate resources for the functioning and continuous improvement of the QMS.
• Conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting.

Qualifications

• Master’s degree in a related field is required.
• Minimum of two (2) years of experience in clinical research with Government, Biotech, Pharma and/or CRO and at least two (2) years of experience in Quality Systems related to GCP.
• A certified quality auditor is preferred.
• Experience auditing clinical CRO’s, clinical sites and investigator sites is required.
• Strong understanding of domestic and international quality and regulatory requirements and ICH/GCP is required.
• Outstanding communication skills (interpersonal, verbal and written).
• Strong experience independently managing complex projects.

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.