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)

• Dispenses research medication to subjects enrolled in clinical trial

• Triages and participates in sponsor monitoring visits and audit

• Ensures medication orders comply with approved protocol

• Provides drug information to other health care professionals
• 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 resident

• Oversees the safe handling and preparation of investigational sterile and non-sterile medication

• 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
• Reviews patient medications for appropriateness
• Monitors patients' medication regimens for drug interactions
• Oversees the safe handling and preparation of investigational medications
• Oversees technician activities and performs quality control checks
• Attends and participates in Institutional Review Board (IRB) meetings
• Reviews new drug protocols as IRB ancillary reviewer

• Completes reports including Safety Reports and Notes to File

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

Qualifications

EXPERIENCE:

Required:

- Hospital Pharmacy experience

Preferred

- Experience gained working in an Investigational Drug Service pharmacy

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:

Current Massachusetts Pharmacy License

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

• Good judgment

• 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

• Flexibility and initiative

• Ability to teach

• Ability to plan, organize and prioritize

• Ability to motivate and develop other

• General understanding of compounding testing requirements I'm not sure we want to include this. These are skills that the applicant should have, rather than those that they will acquire.

• 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 up to 20 lbs.

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