Clinical Pharmacist Investigational Drugs

Job Requirements

General Summary:

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.

Principal Responsibilities and Tasks:

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.

• 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 as follows:
• 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.

Education & Experience:

Required

• Doctorate of Pharmacy Required (PharmD) unless graduated from U.S. School of Pharmacy in or before 2003 OR Foreign Equivalent.
• Maryland Pharmacist License.

Preferred

• One (1) year of experience preferred.

Additional Information

• All your information will be kept confidential according to EEO guidelines.
• Work Schedule: Non-Exempt / Days, 6 am to 6 pm, Rotating 6 am, 8 am or 9:30 am shift. On call and rotating weekends required.

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