Clinical Research Program Specialist (Oncology)
Core
Manage regulatory maintenance of clinical trials, assist in investigator-initiated study development, and ensure compliance for the Oncology Clinical Research Program.
Role type
Clinical Research Regulatory Specialist
Builds
Clinical trial protocols, regulatory submissions, and study operation manuals for faculty and sponsors
Domain
Oncology clinical research in an academic medical center
Deliverable
client delivery
Required skills
Regulatory document management, IRB submission coordination, protocol amendment processing, internal quality assurance, study start-up coordination, institutional database proficiency (Epic, OnCore, eReg, eIRB), SOP development
Preferred skills
ACRP certification
Technologies
Epic, OnCore, eReg, eIRB
Responsibilities
Evaluate study status and complete regulatory requirements including protocol submissions to IRB; assist with revision of investigator-initiated studies to ensure consistent language; track protocols through approval processes; conduct internal quality assurance measures and training sessions; maintain institutional databases for accurate data analysis; assist with program operations and staff orientation.
Seniority
Mid-level specialist