PRN Investigational Drug (IND) Specialist

SCRI Oncology Partners, located in Nashville, Tenn., is a dedicated cancer treatment practice led by globally recognized oncologists with disease expertise in cancer care and clinical research. This practice offers patients state-of-the art personalized cancer care and opportunities to participate in clinical trials with innovative treatments. The practice conducts clinical trials through their affiliation with Sarah Cannon Research Institute (SCRI), a global leader in oncology research that has been offering and managing clinical trials in the community for over 30 years. Since its inception, SCRI-OP has contributed to pivotal research that has helped advance the majority of new cancer therapies approved by the FDA today.

Scope

Under minimal supervision, provides consultative support and training related to Investigational Drug (IND) for the SCRI Oncology Partners pharmacy program. Serves as a subject matter expert for investigational product accountability, disposition, reconciliation, and regulatory compliance following study completion. Collaborates with pharmacy staff, research personnel, sponsors, and investigators to ensure proper handling and documentation of investigational medications in accordance with Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and organizational policies. Supports ongoing pharmacy staff education and competency development related to investigational drug processes.

Key Responsibilities

• Provides expertise regarding investigational drug (IND) accountability, inventory reconciliation, disposition, and destruction processes upon study closure.
• Reviews and reconciles investigational drug records, accountability logs, temperature monitoring documentation, and sponsor-required closeout documentation.
• Assists pharmacy leadership and research staff in identifying and resolving discrepancies related to investigational product inventory and documentation.
• Coordinates and supports sponsor, monitor, and audit-related investigational drug closeout activities.
• Ensures investigational products are managed and documented in accordance with protocol requirements, sponsor instructions, FDA regulations, GCP guidelines, and organizational policies.
• Develops and delivers training programs for pharmacists, and pharmacy technicians on investigational drug management and closeout procedures.
• Creates educational materials, standard work documents, job aids, and competency assessments related to investigational drug processes.
• Evaluates existing workflows and recommends process improvements to enhance compliance, efficiency, and operational readiness.
• Assists with preparation for internal audits and regulatory inspections involving investigational drug management.
• Serves as a resource for pharmacy staff regarding investigational drug regulations, sponsor expectations, and best practices.
• Collaborates with pharmacy leadership on quality assurance initiatives related to investigational drug services.
• Maintains current knowledge of applicable FDA regulations, USP standards, GCP requirements, and investigational drug management practices.

Minimum Job Qualifications (Knowledge, Skills, & Abilities)

Education/Training

• Minimum of High School Diploma in combination with required experience

Business Experience

• Minimum 5 years of experience in oncology pharmacy, investigational drug services, research pharmacy, or clinical trial operations required.

Specialized Knowledge/Skills

• Extensive knowledge of FDA regulations governing investigational drug management.
• Strong understanding of GCP guidelines, sponsor requirements, and research compliance standards.
• Experience with investigational drug accountability systems and documentation requirements.
• Knowledge of oncology clinical trials and investigational oncology agents preferred.
• Excellent communication, presentation, and training skills.
• Strong organizational and project management abilities.
• High attention to detail and accuracy.
• Ability to function independently while collaborating effectively with multidisciplinary teams.
• Proficient in Microsoft Office applications and electronic research systems.

Working Conditions

Environment

• Traditional outpatient oncology clinic, pharmacy, and office environment.
• May require occasional on-site support during audits, monitor visits, or staff training sessions.
• Exposure to conditions common to an oncology practice and research environment.

Physical Requirements

• Extended periods of computer-based work.
• Ability to review and organize investigational drug records and documentation.
• Occasional standing, walking, and lifting of study-related materials weighing up to 25 pounds.

Employment Status

PRN (As Needed)

This position is intended to provide intermittent expertise and operational support for investigational drug study closeout activities, pharmacy compliance reviews, staff education, competency validation, and process improvement initiatives. Hours will vary based on organizational needs, study volume, audit preparation activities, and training requirements.