Research Pharmacist - part time

Join The CTI Team•Plymouth, MI

About The Position

The Research Pharmacist supports clinical research pharmacy operations by reviewing study protocols, pharmacy manuals, and related documents to assess investigational product requirements and operational feasibility. The role develops and implements study-specific pharmacy procedures and manages investigational products throughout the study lifecycle, from receipt and storage through preparation, dispensing, return, transfer, and destruction. The pharmacist provides evidence-based drug information to physician investigators, maintains the sterility and appropriate environmental controls of the pharmacy compounding area, and ensures compliance with protocol requirements, organizational SOPs, Good Clinical Practice, ICH guidelines, FDA regulations, and applicable state and federal pharmacy rules. The role also maintains inventory, accountability records, documentation, and audit readiness; contributes to pharmacy policies and SOPs; and collaborates with investigators, research coordinators, sponsors, CRO representatives, and other study personnel.

Requirements

Active pharmacy license with the applicable State Board of Pharmacy.
Bachelor of Science, master's, or Doctor of Pharmacy degree.
At least 2 years of experience in a pharmacy practice setting.
Knowledge of state and federal regulations relating to storage and dispensing of investigational and marketed drug products.
Proficiency in electronic documentation systems.
Ability to work independently while collaborating effectively within interdisciplinary teams.

Responsibilities

Review protocols, pharmacy manuals, and study-related documents to assess investigational product requirements and operational feasibility.
Develop and implement study-specific pharmacy procedures in accordance with protocol requirements and organizational SOPs.
Receive, inspect, document, store, prepare, compound, label, dispense, return, transfer, and destroy investigational products in compliance with protocol requirements and applicable regulations.
Provide evidence-based drug information to physician investigators to support the proper management of subject medical care.
Conduct pharmacy activities according to applicable sterile and non-sterile compounding regulations.
Maintain sterility of the CTI CRC IDS Pharmacy sterile compounding area in accordance with SOPs and state and federal rules and regulations.
Maintain appropriate environmental controls and storage conditions, including temperature monitoring and documentation for investigational products.
Ensure pharmacy operations comply with GCP, ICH guidelines, FDA regulations, state pharmacy regulations, and organizational policies.
Maintain accurate investigational product inventory, accountability, reconciliation, and documentation throughout the study lifecycle.
Assist in developing and managing pharmacy policies and SOPs.
Maintain drug accountability records and readiness for sponsor audits, monitoring visits, regulatory inspections, and internal quality reviews.
Collaborate with investigators, research coordinators, sponsors, CRO representatives, and other study personnel on investigational product-related activities.
Request assistance and technical advice from the Director, Research Site Operations; Vice President, Research Site Operations; Pharmacist Manager; Principal Investigators; and Site Medical Director.
Follow company policies and applicable laws, guidelines, and job-specific requirements, and behave cooperatively and constructively.
Maintain knowledge across multiple therapeutic areas through literature review, awareness of industry practices, and participation in professional activities.
Perform other duties.