Clinical Pharmacist, Investigational Drugs

University of Maryland Medical System•Baltimore, MD

19d

About The Position

Under general supervision, coordinates the pharmaceutical care component of all drug research conducted within the Medical System to help ensure proficient patient care according to professional standards and practices and regulatory requirements. This role involves developing special procedures for handling investigational drugs, researching and analyzing drug information, planning and coordinating pharmacy participation in drug protocols, ensuring regulatory compliance, and overseeing pharmacy support staff. The position also includes instructing trainees and potentially conducting original research.

Requirements

Bachelor of Pharmacy from a college or university accredited by the American Association of Colleges of Pharmacy is required.
Five years of clinical pharmacy experience required with Bachelor’s degree.
Current licensure by the Maryland State Board of Pharmacy is required
Three years of in-patient pharmacy hospital and/or ambulatory pharmacy experience is required.

Nice To Haves

Master of Science, PhD or Doctor of Pharmacy from a college or university accredited by the American Association of Colleges of Pharmacy is preferred.
Specific experience in clinical research and/or investigational drug service is preferred.

Responsibilities

Coordinates the pharmaceutical care component of all drug research conducted at the University of Maryland Medical System, in accordance with relevant state and federal laws, The Joint Commission regulations, UMMS and departmental policies and procedures.
Develops special procedures for the preparation, dispensing, handling and record keeping of each investigational drug study. Reviews active study procedures continuously.
Researches and provides critical analysis of investigation drug information to pharmacists. Reviews new drug protocols, prepares estimate of cost for pharmacy portion of study; evaluates for feasibility. Assesses the departmental impact of a study on workload, costs and other resources. Negotiates fees for the Investigational Drug Services and develops a pharmacy budget for the study if required.
Plans and coordinates pharmacy participation in drug protocols including ensuring adequate supplies of study materials, preparing blinded and open label dosage forms and instructs all pharmacy, nursing and medical investigator staff accordingly.
Consults with medical and nursing staff when necessary or requested.
Ensures compliance with all regulatory requirements. Assists sponsors in conducting periodic audits. Coordinates study initiation and changes with IRB monthly. Maintains records in compliance with regulatory and sponsor requests.
Maintains established departmental policies, procedures, objectives, quality assurance program, safety, environmental, infection control and generally accepted pharmacy practices. Observes, communicates and enforces safe handling practices with investigational drugs.
Oversees and directs the work of professional and pharmacy support staff who assist in the preparation, distribution and record maintenance of drug orders as well as drug supply maintenance as required.
Instructs Pharmacy students, residents and various other trainees on new drug practices and procedures as appropriate.
Conducts or participates in original research as appropriate.
Assures and/or supervises the cleaning of equipment used in the performance of duties such as Mettler Balance and Laminar Flow Hood (s), if required.
Observes established departmental policies, procedures and quality assurance programs, safety, environmental and infection control standards.