Research Pharmacist - part time

CTI Clinical Trial and Consulting Services • Plymouth Charter Township, MI

10d

About The Position

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization focused on advancing treatments for chronically and critically ill patient populations. The Research Pharmacist supports clinical research by managing investigational products and pharmacy operations throughout the study lifecycle. The role reviews study documents, establishes study-specific procedures, ensures compliant handling and documentation of investigational products, provides drug information to physician investigators, and collaborates with research and sponsor teams. Pharmacy activities must follow applicable clinical research, pharmacy, sterile-compounding, and regulatory requirements.

Requirements

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

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 protocols and applicable regulations.
• Provide evidence-based drug information to physician investigators to support appropriate medical care for subjects.
• Conduct pharmacy activities in accordance with 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.
• Ensure appropriate environmental controls and storage conditions, including temperature monitoring and documentation for investigational products.
• Ensure pharmacy operations comply with Good Clinical Practice (GCP), International Council for Harmonisation (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 standard operating procedures.
• 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 and guidelines, comply with job-specific requirements, and behave in a cooperative and constructive manner.
• Maintain knowledge across multiple therapeutic areas through literature review, awareness of industry practices, and participation in professional activities.
• Perform other duties.

Benefits

• Tuition reimbursement.
• Ongoing education and training opportunities.
• Health benefits.
• Vacation packages.
• Hybrid work opportunities.
• Paid parental leave.
• Opportunities to give back to the community and the world through the CTI Cares program.
• Structured mentoring and leadership development courses.

What This Job Offers

• Job Type: Part-time