"Research Services Professional (Regulatory and Pre-Award) - Open Rank"

The Department of Radiology is seeking a dedicated and detail-oriented Research Services Professional to join our team. This full-time position will be responsible for managing Pre-Award activities and providing regulatory support for an assigned portfolio of grants, contracts, and subcontracts. The successful candidate will work closely with Principal Investigators (PIs) and research staff to coordinate proposal development, assist with regulatory documentation, and ensure compliance with institutional, federal, and sponsor guidelines. This role reports to the Research Services Program Director, with additional oversight from the Clinical Trials Manager.

• Regulatory (40%): Submit clinical trial protocols with applicable essential documents to local IRB (e.g., COMIRB, WCG, CIRB, Advarra). Ensure adherence to local, federal, and institutional research regulatory standards. Manage all regulatory aspects of study start-up and ongoing maintenance to ensure studies open on time and remain compliant. Maintain thorough and organized records for all studies to ensure compliance with FDA regulations, study protocols, departmental procedures, clinical SOPs, and sponsor requirements.
• Pre-Award (50%): Support PIs in preparing all required documentation for grant and sub/contract proposal submissions. Collaborate with faculty, staff, and research teams to plan, coordinate, and support research proposal submissions. Track and monitor proposal deadlines, ensuring timely and compliant submission of all materials. Provide guidance on pre-award procedures, including sponsor-specific requirements, institutional policies, and submission processes. Assist with compiling and collecting required documents for grant proposals, ensuring adherence to sponsor and institutional formatting and compliance guidelines. Coordinate with external collaborators to gather and finalize subaward documentation; manage Just-In-Time submissions. Facilitate routing and submission through Infoed. Collaborate with the research team to develop, refine, and enhance pre-award processes, policies, and procedures. Prepare administrative documents and reports; initiate SpeedType # request, and other related tasks. Maintain accurate records of proposals, submissions, and funding opportunities.
• Clinical and Other (10%): Occasionally serve as clinical trial coordinator back-up, including assisting with pre-screening and consenting potential clinical trial participants. Perform informed consent process or ensure it has been properly conducted, fully documented, and that consent forms are accurately filed in accordance with regulatory requirements. Route various research-related agreements (e.g., Material Transfer Agreements [MTAs], Confidential Disclosure Agreements [CDAs], Non-Disclosure Agreements [NDAs], license agreements) for institutional review and signature. Process Standing Purchase Orders (SPOs) for subcontracts and fee-for-service arrangements through CU Marketplace; submit and track corresponding invoices for payment.

This description provides a general summary of the key responsibilities and scope of work for this position. It is not comprehensive and may change over time to meet the evolving needs of the department.