The Research Regulatory Project Manager position manages the daily regulatory activities for drug, device, and social behavioral studies for various IRBs, multiple departments, and Principal Investigators. Additionally, this individual coordinates and performs administrative research support services. Through the management of research regulatory affairs, the primary focus of the Regulatory Project Manager will be to achieve and maintain compliance with all internal, external and federal policies and regulations that apply to the conduct of human subject research at UCHealth Colorado Springs
FTE Status: Full Time
FTE: 1.000000 (FTE x 80 = hours per pay period)
Responsibilities: Develops project scope, deliverables, and plan in alignment with project objectives.
Manages project implementation to achieve project goals while controlling resources, risks, conflicts, timelines and costs.
Identifies, secures, and coordinates the resources necessary for project success.
Manages project team members. Serves as a mentor and facilitates conflict resolution.
Within scope of job, requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a fast-paced environment and take appropriate action.
1. Prepares study documents for all applicable submissions to the IRB within the project timelines, sponsor or other regulatory authority and corresponds appropriately with these bodies.
2. Coordinates and performs study specific regulatory processes across multiple studies of different therapeutic areas.
3. Provides regulatory guidance, direction and support to all members of the research team at UCHealth Colorado Springs. Apprised of the policies and procedures for applicable IRBs as necessary.
4. Performs a variety of administrative research tasks in support of the study startup team, which includes the utilization of OnCore (Clinical Trial Management System), and use of other institutional systems.
5. Maintains required regulatory documents for departments, physicians, and researchers.
6. Establishes effective and professional relationships with regulatory representatives at multiple institutions and organizations.
7. Prepares and aids departments in the conduct of internal/external audits, and attends applicable monitoring visits to assist in the review and assessment of regulatory documents
Minimum Required Education: Bachelor's degree.
Required Licensure/Certification: None Required.
Minimum Experience: 3 years of relevant experience.
IF APPLICABLE: BLS through the American Heart Association or the American Red Cross CPR for the Professional Rescuer with card in-hand before start date. BLS or CPR card must be good through sixty days of hire. All life support certification cards must be issued by either the American Heart Association or the American Red Cross CPR for the Professional Rescuer. (American Red Cross for the Professional Rescuer is only good upon hire and all renewals will need to be through an American Heart Association sanctioned course.)
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Internal Number: 13373
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