Pharmacist, Healthcare

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Tranquil Clinical and Research Consulting Services LLC, Webster, TX, US

Salary Range: $ To $ Annually

Job Title:

Clinical Research Pharmacist Department:
Pharmacy / Clinical Research

Reports To:

Clinical Research Manager and CNO

Employment Type:

Full-time

Location:

Tranquil Clinical Research

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.

• 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.

• 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.

• 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.

• 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…