Clinical Research Pharmacist

Job Description

The Clinical Research Pharmacist at Tennessee Oncology is responsible for providing clinical resources to clinical trial patients, research department staff, and pharmacy department staff. They ensure local, state, national, and federal regulatory compliance for all medication-related components of clinical trial protocols. They also oversee delegated pharmacist and pharmacy technicians in the preparation of sterile IV admixtures of investigational products and dispensing of oral investigational products. The role involves providing clinical pharmacy services through drug information, patient education, and to the professional staff.

Essential Functions

• Serve as coordinator/liaison between research and pharmacy departments for all clinical trial needs
• Participate in feasibility assessment, protocol review, and site initiation visit (SIV) for all clinical trials
• Provide enhanced oversight for all double-blind clinical trials, including serving as primary un-blinded pharmacist, pharmacy binder maintenance, drug preparation, receipt, destruction, and data entry (when applicable)
• Serve as the training and regulatory point of contact for all delegated pharmacy personnel, including providing ongoing training to pharmacy staff when needed
• Maintain study pharmacy manuals and/or protocols in pharmacy shared drive for pharmacy staff reference
• Communicate with sponsor study monitors and respond to all pharmacy-related inquiries in a timely manner
• Maintain inventory of investigational products in designated storage locations
• Dispense investigational product(s) for all clinical trial patients; research coordinators will provide additional coverage if needed
• Pharmacy contacts for all research-related pharmacy questions (questions from site staff, pharmacists, research team)
• Collaborate with research and pharmacy departments to create interdepartmental standard operating procedures (SOPs)
• Affirm the appropriateness of medication therapy (investigational and commercial) through:
• Review and complete medication reconciliation for clinical trial patients during screening and on an as needed basis
• Review of medication orders for clinical appropriateness based on patients’ specific conditions and concomitant therapies
• Compound and accurately dispense, intravenous solutions and related supplies
• Formulate, prepare, and maintain quality control of pharmaceutical preparations
• Check medication preparation and oversee delegated pharmacy services performed by pharmacy technicians
• Communicate with prescribers and providers regarding appropriateness of drug therapy and patient response to therapy
• Fulfill responsibilities listed in various pharmacist job descriptions on an as-needed basis (e.g., critically low staffing levels)
• Function as a team member by expanding the responsibilities as directed by management to facilitate optimal workflow within the cancer center
• Completes expected competencies as defined by manager
• Serve on various committees, as requested, as expert resource for IDSM

Knowledge, Skills & Abilities

• Proven presentation experience
• Possess the personal characteristics of professionalism, credibility, commitment to high standards, and innovation
• Adept to continual learning and development
• Effective communication skills including patient education, staff mentoring and drug information to the extended health care team
• Self-starter with the ability to work independently and within a team
• Accomplished in team building and management
• Knowledge and compliance of regulatory bodies that apply to IDS

Education & Experience

• Doctor of Pharmacy (PharmD); Bachelor’s Degree in Pharmacy (BS Pharm)
• Successful completion of a PGY1 and/or PGY2 residency specializing in oncology or 3 years of clinical pharmacy/IDS experience
• Current, active, and unrestricted Tennessee Pharmacy licensure