PRN Investigational Drug (IND) Specialist
About The Position
SCRI Oncology Partners is a dedicated cancer treatment practice in Nashville, Tennessee, led by oncologists with expertise in cancer care and clinical research. The practice provides personalized cancer care and access to clinical trials through its affiliation with Sarah Cannon Research Institute. Under minimal supervision, the Investigational Drug (IND) Specialist provides consultative support and training for the SCRI Oncology Partners pharmacy program. The specialist serves as a subject matter expert in investigational product accountability, disposition, reconciliation, and regulatory compliance following study completion. The role works with pharmacy staff, research personnel, sponsors, and investigators to ensure investigational medications are handled and documented in accordance with Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and organizational policies. It also supports pharmacy staff education and competency development related to investigational drug processes. This is an as-needed position providing intermittent expertise and operational support for investigational drug study closeouts, pharmacy compliance reviews, staff education, competency validation, and process improvement. Hours vary according to organizational needs, study volume, audit preparation, and training requirements.
Requirements
- High school diploma combined with the required experience.
- At least 5 years of experience in oncology pharmacy, investigational drug services, research pharmacy, or clinical trial operations.
- 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.
- Excellent communication, presentation, and training skills.
- Strong organizational and project management abilities.
- High attention to detail and accuracy.
- Ability to work independently and collaborate effectively with multidisciplinary teams.
- Proficiency in Microsoft Office applications and electronic research systems.
Nice To Haves
- Knowledge of oncology clinical trials and investigational oncology agents.
Responsibilities
- Provide expertise on investigational drug accountability, inventory reconciliation, disposition, and destruction processes upon study closure.
- Review and reconcile investigational drug records, accountability logs, temperature monitoring documentation, and sponsor-required closeout documentation.
- Help pharmacy leadership and research staff identify and resolve discrepancies in investigational product inventory and documentation.
- Coordinate and support sponsor, monitor, and audit-related investigational drug closeout activities.
- Ensure investigational products are managed and documented in accordance with protocol requirements, sponsor instructions, FDA regulations, GCP guidelines, and organizational policies.
- Develop and deliver investigational drug management and closeout training for pharmacists and pharmacy technicians.
- Create educational materials, standard work documents, job aids, and competency assessments related to investigational drug processes.
- Evaluate workflows and recommend improvements to compliance, efficiency, and operational readiness.
- Assist with preparation for internal audits and regulatory inspections involving investigational drug management.
- Serve as a resource to pharmacy staff on investigational drug regulations, sponsor expectations, and best practices.
- Collaborate with pharmacy leadership on quality assurance initiatives related to investigational drug services.
- Maintain current knowledge of applicable FDA regulations, USP standards, GCP requirements, and investigational drug management practices.
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What This Job Offers
Education Level
High school or GED
