This position is located at New Mexico VA Health Care System (NMVAHCS) in the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CRPCC). CRPCC provides pharmaceutical, regulatory, and study participant safety monitoring support for clinical research studies impacting veterans' health and national medical practice.Learn more about this agency
The Pharmacist (Program Manager) is responsible for a distinct and unique set of studies and directs project teams consisting of personnel assigned from each of the specialized sections. Serves as a member of the Cooperative Studies Program planning and executive committees for assigned studies while supporting five to ten multi-center studies in various stages of completion. The incumbent must deal with problems of multiple observers and laboratories.
Typical duties will include but are not limited to:
- Act as the program liaison to the FDA and preparing submissions and coordinating all correspondence.
- Negotiate with pharmaceutical industry and coordinating the manufacture of study drugs.
- Monitor the safety aspects of study drugs/devices (side effects and adverse effects).
- Prepare, control and distribute study drugs/devices to all study sites.
- Develop drug/device treatment and handling protocols, operations manuals and investigator brochures for study clinics of participating medical centers.
- Monitor drug use, adverse medical events and concomitant therapy of patients in clinical trials.
- Assist in the rational selection of drugs and doses and direct the formulation of investigation drug information for use in clinical research.
- Prepare manuscripts for the publication of results of assigned studies and conducting independent research.
- Design forms and procedures for monitoring and reporting adverse medical events.
- Inspect and approves investigational drug shipments prepared by Production Controllers to assure the correct drug and dosage forms are present in each shipment.
- Control and account for all study drug use.
- Formulate and execute plans to dispose of unused study drugs and supplies, notifying study chairmen, biostatisticians and pharmaceutical companies.
Financial Disclosure Report: Not required
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/538594600. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.