Pharmacist, Investigational Drug Services

Pharmacist, Investigational Drug Services

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.

The Pharmacist, Investigational Drug Services manages all aspects of Investigational Drug Services (IDS) and operations for clinical trials, including receipt, storage, preparation, dispensing, accountability, and documentation of study drugs, ensuring compliance with protocols, SOPs, regulatory requirements, and Good Clinical Practice (GCP) standards

Job Duties and Responsibilities:

• Demonstrates expert knowledge and application of applicable regulatory and ethical standards governing investigational drug research, including Code of Federal Regulations, ICH Good Clinical Practice (GCP), HIPAA, state board of pharmacy regulations, institutional policies to ensure compliant and high-quality research pharmacy operations.
• Attend Site Initiation Visits (SIVs) to support investigational drug product planning, study start-up, site readiness, and activation.
• Attend and contribute to Study Feasibility and Billing Compliance meetings to ensure IDS requirements and considerations are captured in clinical, regulatory, finance, and legal study start-up and activation documents in support of site readiness.
• Initiate the development of medication orders, Epic Willow medication builds, and clinical trial Beacon protocol builds and collaborate with clinical trials staff in the finalization and validation of the final orders and protocols.
• Planning and execution of study-specific blinding and unblinding plans for investigational products, ensuring compliance with protocol requirements, maintaining trial integrity, and coordinating with pharmacy and clinical teams to support blinded study operations.
• Manage the receipt, storage, preparation, dispensing, and return or destruction of investigational products in accordance with institutional policies, study protocols, and regulatory requirements.
• Maintain complete, accurate, up-to-date records and documentation of all investigational product transactions, including inventory, shipment receipt, dispensing logs, temperature monitoring, and accountability documentation.
• Ensure proper labeling, packaging, and handling of study drugs to maintain product integrity and patient safety.
• Conduct quality control and assurance checks on investigational drug product processes, including compliance with FDA, ICH-GCP, and institutional policies.

Physical and Sensory Requirements:

Sitting for up to eight hours per day and up to three consecutive hours. Standing for up to eight hours per day and up to six consecutive hours. Walking for up to eight hours per day and up to 30 consecutive minutes. Frequently handling, firm grasping, twisting and turning. Occasionally reaching above shoulder level; frequently looking up. Occasionally lifting up to 20 pounds and carrying up to 35 pounds and pushing up to 50 pounds. Occasionally stooping, bending, squatting, crouching, and kneeling. Hearing as it relates to normal conversation, high and low frequency. Seeing as it relates to general vision, near vision, far vision, depth perception, peripheral vision, color vision, and monotony.

Education:

Doctor of Pharmacy (PharmD) from an ACPE-accredited school of pharmacy required. Active, unrestricted pharmacist license in the State of Pennsylvania.

Training and Experience:

Minimum of 3 years of progressive experience as a pharmacist in a hospital or health system setting with experience in accurate profiling, preparation, and dispensing of new medication orders including chemotherapy. Experience in clinical research environment or Investigational Drug Services (IDS). Strong organizational and communication skills. Demonstrated experience with sterile and non-sterile medication preparation, including compliance with USP <797> and <800> , hazardous drug handling, and aseptic technique. Experience with sterile and non-sterile investigational product preparation. Practical knowledge of FDA regulations (including 21 CFR Parts 11, 50, 54, 56, 312, 812), ICH-GCP, Human Subject Protection, HIPAA, and sponsor-specific pharmacy manuals.

St. Luke's University Health Network is an Equal Opportunity Employer.

St. Lukes University Health Network