Clinical Trial Site Pharmacist

Bethany Medical•High Point, NC

About The Position

The Clinical Trial Site Pharmacist will support the conduct of clinical research studies by managing investigational products in accordance with study protocols, sponsor requirements, regulatory standards, and institutional policies. This role is responsible for ensuring proper storage, handling, preparation, dispensing, documentation, and accountability of investigational medications used in clinical trials. The pharmacist will work closely with the Principal Investigator, Sub-Investigators, clinical research coordinators, and study sponsors to ensure compliance with Good Clinical Practice (GCP), FDA regulations, and sponsor requirements.

Requirements

Licensed Pharmacist in good standing.
Experience in pharmacy practice within a clinical, hospital, or outpatient setting.
Strong knowledge of medication management, safety practices, and regulatory compliance.
Strong attention to detail and documentation accuracy.
Ability to work collaboratively with investigators, research coordinators, sponsors, and multidisciplinary teams.
Excellent organizational, communication, and problem-solving skills.

Nice To Haves

Experience with investigational drug services or clinical trials is preferred but not required.

Responsibilities

Manage investigational drug products in accordance with study protocols, sponsor requirements, and regulatory standards.
Maintain investigational drug accountability logs, dispensing records, and pharmacy documentation for clinical trials.
Ensure proper storage, handling, temperature monitoring, and security of investigational products.
Prepare and dispense investigational medications in accordance with protocol requirements and physician orders.
Verify protocol-specific dosing requirements and medication preparation instructions.
Provide medication-related consultation to investigators, sub-investigators, and research staff regarding study drugs.
Educate research staff and study participants regarding investigational medication administration when appropriate.
Participate in study initiation activities, including review of pharmacy manuals, investigational drug handling requirements, and sponsor pharmacy training.
Communicate with study sponsors, contract research organizations (CROs), and monitors regarding investigational product management and pharmacy-related study requirements.
Support monitoring visits, audits, and inspections by providing pharmacy documentation and investigational product accountability records.
Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and institutional policies related to investigational drug services.