Pharmacist

Job Title: Clinical Research Pharmacist
Department: Pharmacy / Clinical Research
Reports To: Clinical Research Manager and CNO
Employment Type: Full-time
Location: Tranquil Clinical Research

Position Summary

The Clinical Research Pharmacist is responsible for the safe, compliant, and effective management of investigational drugs and clinical trial pharmacy activities. This position works closely with investigators, research coordinators, physicians, nurses, sponsors, contract research organizations (CROs), and pharmacy staff to support the conduct of clinical research in accordance with applicable regulations, institutional policies, study protocols, and Good Clinical Practice (GCP) standards.

The Clinical Research Pharmacist provides pharmaceutical expertise throughout the clinical trial lifecycle, including study start-up, investigational product (IP) receipt and storage, preparation and dispensing, drug accountability, monitoring visits, protocol compliance, and study closeout.

Key Responsibilities

Clinical Trial Pharmacy Operations

• Review and interpret clinical trial protocols, pharmacy manuals, investigational product (IP) information, and related study documents.
• Evaluate medication-related aspects of research protocols for feasibility, safety, operational requirements, and compliance.
• Coordinate receipt, storage, preparation, dispensing, administration, return, and destruction of investigational medications.
• Ensure investigational products are stored under appropriate temperature, security, and environmental conditions.
• Maintain accurate investigational product accountability records and documentation.
• Prepare investigational medications according to approved protocols, institutional procedures, and applicable standards.
• Verify study-specific dispensing requirements, dosing schedules, treatment assignments, and medication instructions.
• Maintain appropriate blinding and randomization procedures when required by the study protocol.

Regulatory and Compliance

• Ensure clinical trial pharmacy activities comply with applicable FDA requirements, institutional policies, GCP standards, and other relevant regulations.
• Maintain complete and accurate essential documents and pharmacy-specific study records.
• Support preparation for and participation in sponsor, CRO, institutional, and regulatory monitoring or auditing activities.
• Identify, document, and communicate protocol deviations, medication errors, temperature excursions, and other investigational product issues.
• Assist with development and maintenance of pharmacy-specific policies, standard operating procedures (SOPs), and study workflows.

Study Start-Up and Closeout

• Participate in feasibility assessments and study initiation activities.
• Review pharmacy requirements during study start-up and identify operational needs.
• Collaborate with research teams to establish study-specific pharmacy procedures.
• Participate in site initiation visits and investigator meetings as appropriate.
• Coordinate investigational product reconciliation and disposition during study closeout.
• Ensure appropriate documentation and resolution of outstanding pharmacy-related study issues.

Clinical Research Collaboration and Coordination

• Serve as a pharmacy subject-matter expert for clinical research teams.
• Collaborate with investigators and research staff regarding investigational medications, dosing, interactions, contraindications, and safety considerations.
• Provide medication-related education to research staff and other healthcare professionals.
• Contribute to clinical research projects, publications, presentations, quality-improvement initiatives, and research-related pharmacy programs as appropriate.
• Assist in the development and implementation of research pharmacy workflows and processes.
• Screen and enroll study subjects:

• Review the study design and inclusion/exclusion criteria with the subject's primary physician
• Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility
• Review the protocol, informed consent form and follow-up procedures with potential study subjects
• Ensure that the current approved informed consent is signed before subjects are screened and enrolled
• Ensure that the randomization procedure is followed as per protocol guidelines
• Document protocol exemptions and deviations.

• Manage study-related activities, subject compliance, and documentation:

• Ensure adherence to protocol requirements
• Assist investigators in assessment of subject response to therapy
• Review laboratory data, inform investigator of abnormal values and document
• Assess and document subject compliance with medications and visits
• Manage administration of investigational therapy
• Maintain dispensing logs (if allowed) Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
• Oversee specimen collection, storage and shipment
• Attend study-related meetings as appropriate
• Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.

• Record data and study documentation:

• Record data as directed using the appropriate media or platform
• Follow procedures for access and security for electronic data entry
• Review keyed data for accuracy, as needed
• Send data to the data collection center on a timely basis
• Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
• Correct and edit data as directed and as appropriate.

Quality and Safety

• Promote medication safety and patient safety throughout the clinical trial process.
• Review investigational medication orders for appropriateness and protocol compliance.
• Monitor for potential drug interactions, duplicate therapy, contraindications, and other medication-related risks.
• Participate in investigation and resolution of medication-related safety events.
• Support continuous quality improvement activities within the clinical research pharmacy.

Qualifications

Required

• Doctor of Pharmacy (PharmD) or equivalent pharmacy degree from an accredited institution.
• Active pharmacist license in the applicable jurisdiction.
• Experience or demonstrated knowledge of clinical research, investigational drugs, or clinical trial pharmacy operations.
• Working knowledge of Good Clinical Practice (GCP) principles and applicable investigational drug regulations.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work effectively with multidisciplinary research and healthcare teams.

Preferred

• Residency training in pharmacy practice, clinical pharmacy, or a related specialty.
• Board certification in a relevant pharmacy specialty.
• Experience working with Phase I-IV clinical trials.
• Experience with investigational drug services or research pharmacy operations.
• Experience with electronic clinical trial management systems, pharmacy information systems, or electronic health records.
• Knowledge of FDA regulations and institutional review board (IRB) requirements.
• Experience with sponsor and regulatory audits or inspections.
• Certification or formal training in GCP, clinical research, or investigational drug management.

Key Competencies

• Clinical and pharmacotherapeutic knowledge
• Investigational product management
• Clinical research and GCP knowledge
• Regulatory compliance
• Medication safety
• Protocol interpretation
• Attention to detail
• Documentation and record management
• Problem-solving and critical thinking
• Communication and collaboration
• Time management and organization
• Ability to manage multiple concurrent clinical trials

Physical and Work Requirements

• Ability to work in a pharmacy, clinical, research, and/or healthcare environment.
• Ability to stand, walk, and perform routine pharmacy-related activities for extended periods as required.
• Ability to handle medications and pharmacy materials in accordance with institutional safety procedures.
• Ability to maintain accurate records and perform computer-based work for extended periods.