Clinical Trials Pharmacist

GENERAL SUMMARY/ OVERVIEW STATEMENT:

As an integral member of the pharmacy team, the Clinical Trials Pharmacist is responsible for coordinating, collaborating, and providing expertise in support of drug clinical trials. The Pharmacist will review protocol documents, draft instructions, dispense investigational medication, provide supervision, perform educational activities, communicate with the sponsor and study staff, participate in patient care, maintain overall responsibility for pharmacy operations in the assigned area and perform other duties consistent with the job classification and as required.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Working in conjunction with the Clinical Trial Pharmacy (CTP) Manager, Pharmacist and Technicians, the Pharmacist

• Review new protocols and amendments for drug safety and feasibility.

• Reviews protocol documents and drafts dispense instruction

• Acts as a liaison for principal investigators, the research office, sponsors, pharmacy, and the Institutional Review Board (IRB).

• Ensures medication orders comply with approved protocols.

• Dispenses research medication to subjects enrolled in clinical trial

• Reviews patient medications for appropriateness.

• Reviews patients' medication regimens for drug interactions. Addresses issues with study team.

• Triages and participates in sponsor monitoring visits and audits.

• Manages investigational drug inventory for studies. Coordinates drug receipt, destruction and returns per protocol.

• Oversees the safe handling and preparation of investigational medications.

• Provides drug information to other health care professionals.

• Reviews new drug protocols as IRB ancillary reviewer.

• Promotes a culture of safety; adheres to established practices and policies of the department and notifies the manager of deviations in standard practices.

• Participate in the training and mentorship of new employees, students and residents.

• Acts as a liaison between CTP and compounding, as well as other areas within the department of pharmacy.

• Assists with special projects assigned by the manager.

• Assures that adequate communication is maintained between staff for continuity of service.

• Participates in and identifies quality improvement projects.

• Oversees technician activities and performs quality control checks.

• Attends and participates in Institutional Review Board (IRB) meetings.

• Completes reports including Safety Reports and Notes to File.

• Complies with state and federal laws pertinent to pharmacy and investigational drug use.

Qualifications

REQUIRED:

• Massachusetts Pharmacist License in good standing

• Hospital Pharmacy Experience

PREFERRED:

• Research pharmacy experience

• Non-sterile and Sterile compounding experience

• Human Subject Research Protection (HSRP) certification

• Good Clinical Practice (GCP) certification

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Excellent verbal and written communication skill

• Proficient computer related skills, outlook Microsoft Office Word, Excel, PowerPoint and Acce

• Fluency in English

• Excellent interpersonal and communication skill

• Ability to recognize emergency situations and respond appropriately

• Excellent comprehension of written policies and procedure

• Ability to make appropriate decisions, develop and complete follow-up action

• Attention to detail and organizational ability

• Ability to work well on a team as well as independently

• Ability to plan, organize and prioritize

• Ability to motivate and develop other

• General understanding of compounding testing requirements.

• Ability to meet deadline

• Competent in math skills, including proportions, ratios and conversion

• Excellent telephone skill

• Monitors and assures security of narcotics and controlled substances in accordance with hospital policy, as well as Federal and State Law

WORKING CONDITIONS:

Must be able to lift to 20 lbs.

Must be able to stand or sit for extended periods of time.

EEO Statement

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.