Clinical Pharmacist, Investigational Drugs

University of Maryland Medical System; Baltimore (MD); On-site; USD 120,000 - 150,000; Full time

Job summary

University of Maryland Medical System seeks a licensed Pharmacist to coordinate pharmaceutical care for drug research. The role requires a PharmD and Maryland license, with a preference for 1 year of experience.

Responsibilities include protocol development, budget estimation, staff coordination, and ensuring regulatory compliance across studies. On-site, full-time position with rotating shifts and on-call duties. Training and oversight of students and residents are included.

Qualifications

• Doctorate of Pharmacy is required unless graduated from U.S. School of Pharmacy in or before 2003 or foreign equivalent.
• Maryland Pharmacist License is required.

Responsibilities

• Coordinate the pharmaceutical care component of drug research in accordance with state and federal laws and joint commission regulations.
• Develop procedures for preparation, dispensing, handling and record-keeping of investigational drugs; review active study procedures.
• Review drug protocols, estimate pharmacy budget, and assess workload and resources.
• Coordinate pharmacy participation in drug protocols, ensure adequate supplies, and instruct staff accordingly.
• Consult with medical and nursing staff when necessary and ensure regulatory compliance; assist sponsors in audits.
• Maintain and enforce safety, infection control and QA standards; supervise staff and trainees as appropriate.
• Oversee cleaning and maintenance of equipment used in duties; ensure adherence to policies.

Education

Doctorate of Pharmacy (PharmD)

Maryland Pharmacist License

1 year of experience preferred

Job description

Job Requirements

• Schedule: Days, 6 am to 6 pm, Rotating 6 am, 8 am or 9:30 am shift. On call and rotating weekends required.

Details

• Full Time
• Non-Exempt
• Schedule: Days, 6 am to 6 pm, Rotating 6 am, 8 am or 9:30 am shift. On call and rotating weekends required.

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.

Responsibilities

II. 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.

Work Experience

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.

Education & Experience - Preferred

• 1 year of experience preferred.