Project Manager
CAMRISAbout the role
Overview
We are seeking a Project 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
- Conduct or review on-site inspections at DIR international sites to assess adherence to study protocols, ensure compliance with regulatory requirements and guidelines and quality control and assurance procedures, adherence to laboratory procedures, review progress, study protocols, good clinical practices (GCP), good laboratory practices (GLP), good manufacturing practices (GMP), and the College of American Pathologists (CAP) or CAP-equivalent standards, as appropriate.
- Assist with establishing and monitoring quality assurance (QA)/quality control (QC) programs at DIR international sites.
- Collaborate directly with operating entities to make certain that inspections and audits of DIR international sites are conducted on a continuing basis as specified to enforce mandated requirements and meet specifications.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
- Responsible for preparing and submitting detailed reports of site visits to cite specific improvement and implementation recommendations.
- Develop recommendations for improving the safety, regulatory compliance, and efficiency of laboratory operations and provides critical feedback to the Federal Task Leader, technical support staff and investigators.
Qualifications
- BS degree or 5 years of work experience is equivalent to BS degree.
- 5 years of work experience is required.
- Effective and clear communication skills and the ability to work in a high stress environment.
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.
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