Clinical Advisor

Overview

We 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

• Participate in the review, planning and implementation of clinical trials. This will include the evaluation of study design, feasibility, pharmaceutical regulatory requirements, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
• Develop the text for the study product section of the protocols in cooperation with members of the protocol team and the pharmaceutical manufacturers for existing pharmaceutical products as well as new chemical entities and modalities. This includes researching and analyzing background material from Investigator’s Brochures, prescribing information, and literature reviews.
• Advise the study team and DAIT leadership regarding pharmacy aspects of proposed studies.
• Develop protocol specific training for site pharmacists and clinic staff utilizing web-based systems, software, or other tools (i.e., power point presentation).
• Provide leadership in collaboration with DAIT Project Managers and Regulatory Officers for developing study-specific blind labeling and packaging plan and strategies.
• Review and approve study-specific labels by DAIT CPC.
• Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.
• Ensure that pharmaceutical concerns raised during the DCRC and other meetings are addressed in a timely manner.
• Advise the protocol team regarding pharmaceutical issues relating to DAIT/NIAID standards, FDA and other Health Authorities regulations, State and in-country requirements.
• Evaluate the protocol and provide leadership with estimates of study product needs and or cost based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.
• Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.
• Generate Study Product Request Letter/ Email for study-specific and division leadership’s review and approval.
• Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
• Conduct site visits as required to obtain information about existing infrastructure and processes to use to evaluate pharmacy personnel and infrastructure capacity at production facilities and Clinical Research Sites, as well as for-cause site visits as needed.
• Review Pharmacy Establishment Plans with the site Pharmacist of Record and DAIT Project Managers to obtain information and clarity needed for final review and approval.
• Evaluate and finalize all temperature excursions that occur during shipment and at Research Pharmacy Sites in collaboration with Regulatory Officers.
• Receive and process product complaints with or without AES/SAEs from research site pharmacies.
• Write/draft Standard Operating Procedures (SOPs) related to DAIT Pharmaceutical Services and participate in SOP review committees as needed.
• Assist DAIT/ NIAID Regulatory Officers in writing the Chemistry, Manufacturing, and Control (CMC) section of the Investigational-new drug (IND) application.
• Assist DAIT/ NIAID Clinical Product Center (CPC) Project Officer (PO)/ Contract Officer Representative (COR) in providing daily instructions, approvals for the CPC and other duties as needed for CPC oversight.
• Review and approve study-specific batch records submitted by DAIT CPC.
• Utilize pharmacy practice experience and pharmaceutical ex