- Serve as the subject matter expert on matters related to pharmacy practice, investigational and commercial clinical trial material, drug information, and medication use processes and procedures.
- Serve as pharmacy liaison in the development/review of protocols and other study related documents with an emphasis on the investigational product related sections.
- Liaise with the Division Programmatic Branches, protocol team, Principal Investigator (PI), and other site personnel in Manual of Procedure (MOP) development, and when necessary, train site personnel on proper mixing/dispensing procedures.
- Liaise with manufacturers to resolve temperature excursions and stability issues.
- Work with DMID contractors and subcontractors to facilitate investigational product review and management.
- Assist in the coordination and development of all pharmacy-related activities, projects, and tasks within the DMID Product Support Team as defined by the Director of the Office of Regulatory Affairs.
- Attend and contribute to interdisciplinary team meetings relating to clinical trials.
- Maintain and update the DMID Study Product Management Guidelines to ensure compliance with all applicable regulations.
- Pharmacy and/or Pharm.D. is required.
- Experience in clinical research, protocol development and conduct, clinical practice, pharmaceutical industry, home health and infusion, and/or infectious diseases practice is required.
- Minimum of three (3) years of related experience. Examples of desired experience include investigational drug related experience, drug manufacturing experience, or clinical trial management experience.
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Clinical Advisor - Bethesda, United States - CAMRIS International, LLC
Description
OverviewWe are seeking a Clinical Advisor 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
Qualifications
CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at . 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.
