Clinical Pharmacy Coordinator
We are currently searching for a Clinical Pharmacy Coordinator to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, MD.
Duties & Responsibilities
- Support the dispensing of NIH investigational products for administration in clinical trials.
- Support NIH Investigational Product Management as oriented by the Pharmacist.
- Assist with providing pharmaceutical expertise and recommendations on pharmacy queries, product management issues, product availability during protocol conduct.
- Assist in the review of protocols and investigational brochures.
- Participate in site initiation visits, site qualifying visits, and protocol start-up meetings.
- Interact with physicians, nurses, outside sponsors, and other health professionals throughout the life cycle of the clinical trial to make needed adjustments to procedures and specifications as required per protocol and per federal regulations.
- Serve as a point of contact for Protocols and correspond with principal investigators, study coordinators, and sponsors.
- Schedule and participate in monitoring visits for protocols and answer any questions from auditor and monitor.
- Ensure that Investigational drug supplies for all protocols are obtained and maintained under the proper storage conditions and assist in preparing documents for temperature excursion reporting.
- Provide input on the pharmacy section of monitoring reports and provide responses to any issues noted.
- Provide input on the pharmacy monitoring section of Clinical Monitoring Plans, as requested.
- Assist in the preparation and implementation of pharmacy procedural set-up.
- Assist in the preparation of investigational drug information and documents which provide specific guidelines how to handle and dispense the investigational drug.
- Bachelor’s degree, preferably in Biological Sciences or Life Sciences is preferred but not required.
- Licensed pharmacy technician in a State, District of Columbia, or a territory of the United States is required.
- Minimum of three (3) years of experience working in a clinical trial pharmacy, Investigational Drug Service (IDS) Pharmacy preferred.
- Minimum of three (3) experience of experience providing research support and investigational drug management, including but not limited to: ordering, receiving, auditing, labeling, dispensing, and handling of investigational product returns.
- Experience with use of an electronic inventory system and IVRS/IWRS for drug accountability is preferred.
- Experience with pharmacy preparation for a GCP or FDA study audit is preferred.
- Analytical thinking and problem-solving skills to review and resolve monitoring and/or audit discrepancies or other pharmacy issues is required.
- Excellent working knowledge of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), standard pharmacy practices, including USP aseptic technique and USP hazardous drug handling is required.
- Excellent math skills to perform pharmaceutical calculations.
- Experience in the planning (site assessments, design, logistics), implementation, conduct, close-out, and oversight of clinical trials.
- Ability to work independently and as part of a team.
- Strong organizational skills.
- Excellent oral and written communication skills.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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