Research Program Manager - Investigator Initiated Studies
About The Position
The Research Program Manager, Investigator-Initiated Studies serves as the primary program management lead and faculty-facing partner for investigator-led research studies managed through the Division of Institutional Research. This role provides end-to-end support from early concept development and grant strategy through study activation, execution, and closeout. This position works alongside investigators during the formative stages, helping shape scientifically and operationally feasible study designs, identifying funding pathways, and coordinating cross-functional teams needed to move from concept to an IRB-ready, fundable study. The successful candidate brings scientific literacy, genuine service orientation, and the ability to influence progress across stakeholders without direct authority.
Requirements
- Bachelors in a life science, health science, epidemiology, public health, or related field Required
- Minimum 3 years of experience in clinical research, research program coordination, or a research-adjacent role within an academic medical center, university research setting, or comparable environment Required
- Demonstrated experience engaging with research at a scientific or conceptual level, such as involvement in protocol development, grant preparation, study design, or working alongside principal investigators on faculty-initiated research Required
- Knowledge of FDA regulations, GCP guidelines, OHRP requirements, and IRB processes governing clinical Required
Nice To Haves
- Masters PhD, or equivalent advanced degree in a life science, health science, clinical research, or public health field Preferred
- 5 or more years of experience supporting investigator-led research across multiple study types (interventional trials, observational, translational, retrospective Preferred
- Experience coordinating NIH, NCI, DOD, or foundation grant submissions; familiarity with Grants.gov or eRA Commons Preferred
- Proficiency with electronic research management systems Preferred
- Certification as a CCRC, CCRA, or PMP Preferred
Responsibilities
- Partner with investigators early to translate scientific questions into feasible study designs, surfacing operational or regulatory constraints before they become barriers.
- Identify relevant funding opportunities and support grant submissions: coordinate timelines, track requirements, and facilitate communication with grants administration and collaborators.
- Facilitate protocol and grant development by connecting investigators with biostatisticians, regulatory affairs, data managers, and other subject matter experts.
- Conduct initial needs assessments with incoming investigators; develop study-specific project plans, timelines, and milestone trackers from protocol development through activation.
- Coordinate with Regulatory Affairs to support IRB submissions, protocol amendments, consent form development, and regulatory documentation.
- Assist investigators in identifying and engaging operational partners within the HonorHealth network and external academic collaborators.
- Monitor study progress against timelines; proactively identify and resolve barriers, escalating issues through the right stakeholders before they affect study integrity.
- Maintain consistent follow-up with investigators and operational partners to ensure action items and deliverables are completed on schedule.
- Serve as the liaison between investigators and operational partners including nursing, pharmacy, laboratory, imaging, and clinical staff.
- Contribute to Division portfolio reporting (CTMS, mid-year/annual reports); present study status updates in Division meetings.
- Coordinate study closeout: final data reconciliation, regulatory file archival, and IRB closure notifications.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
