Oversees all aspects of pharmacy activity required to support Clinical Research for MHRI. Serves as liaison between medical staff, research coordinators, study monitors, sponsors, and pharmacy personnel. Insures compliance with applicable local, state and federal regulations involving the receipt, storage, handling and use of investigational drugs.
Principal Duties and Responsibilities:
- Prepare doses of oral and parenteral study drug medication under the supervision of a pharmacist and in accordance with study guidelines;
- Update and maintain records of the receipt, dispensing, storage, and return or destruction of study related materials in accordance with Federal, local, and hospital regulations;
- Update and maintain computer databases of study related activities;
- Act as a liaison to medical staff, research coordinators, study monitors, sponsors, and other MedStar research personnel;
- Assist in the preparation of guidelines for the proper preparation and handling of research medications based on study protocols and related materials;
- Perform and maintain records of a monthly investigational drug inventory;
- Assist in the preparation and distribution of monthly invoices for research pharmacy activity;
- Assist in the cataloging and storage of research pharmacy records for terminated or closed studies in compliance with Federal and international regulations;
- Assist in the preparation and delivery of educational information regarding new research studies;
- Assist in the development of computer programs and other aids to monitor and improve the research pharmacy program and aid other support personnel;
- Update and maintain required logs and records;
- Provide information and assistance to Washington Hospital Center (WHC) Pharmacy Staff regarding investigational drugs;
- Provide off-hours and weekend service if required in support of investigational therapies being administered to WHC patients.
- Consistently demonstrates support for compliance in the performance of job duties and responsibilities by a) developing and maintaining knowledge of, and performing job functions in compliance with, rules, regulations, policies, and statutes that affect his/her job; b) maintaining knowledge of and performing job functions in compliance with MedStar Health and MedStar Health Research Institute policies and procedures; and c) reporting compliance concerns in an appropriate and timely manner.
- Perfoms other duties as assigned.
Education: Bachelor’s degree in a basic science
Experience: Minimum of one year’s experience in a pharmacy, research, or laboratory setting
Excellent written and oral communication skills
Familiarity with word processing and database management computer programs
Ability to function in a highly structured, detail-oriented environment is essential