Clinical Advisor

Overview

We are seeking a Clinical Advisor to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. 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.  

Responsibilities

• Develop and adhere to relevant SOPs and pharmacy manuals.
• Review investigator brochures and conduct literature searches if needed to serve as subject matter expert regarding investigational products in ongoing research protocols.
• Oversee training of staff.
• Manage the quality control, completion and submission of study related documentation.
• Prepare, submit and maintain Institutional Review Board (IRB), FDA, and/or other regulatory documents and research correspondence as needed.
• Monitor protocol compliance.
• Perform clinical data interpretation and data entry as needed.
• Answer questions regarding sterile compounding of investigational products.
• Establish cold-chain plans for transportation and storage of investigational products.
• Evaluate site pharmacies and give recommendations on their ability to meet protocol requirements for investigational product handling, storage, preparation, and dispensing. 

Qualifications

• Pharm.D. or B.S. pharmacist (prior to 1992).
• Licensed to practice pharmacy in one of the US States or Territories.
• Completion of Good Clinical Practice (GCP) and Human Subjects Protection training and experience working in a GCP setting.
• Experience with FDA 21 CFR 312 regulations.
• Experience in a pharmacy practice setting working with sterile products and cold-chain of products.
• Experience in clinical research setting with protocols and clinical trials.
• Strong writing and record keeping skills.
• Knowledge of the roles and responsibilities of an investigational drug research pharmacist.

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.