Clinical Research Startup Specialist

Job Summary

The Clinical Research Support Team (CReST) is part of Office of the Vice Chancellor of Research (OVCR). CReST provides a la carte support services to clinical investigators for all activities related to the successful conduct of clinical research, from study start-up through close out. This is the cornerstone to translate basic science knowledge into clinically useful treatment for patients.

The Clinical Research Support Team (CReST) has an opening for a full-time Clinical Research Startup Specialist to provide regulatory and operationalization startup support for a variety of interventional and observational studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals, including FDA regulated trials with industry, federal, and non-profit funding.

This position will have independent decision making and project management responsibilities and will consult with CReST leadership on the CReST program's study startup activities, status, metrics, and capacity. Knowledge of Good Clinical Practice, applicable regulations, and of the clinical trial lifecycle is essential.

Key Responsibilities

Startup (70%)

• Under the supervision of the Startup Manager, completes study startup projects and activities for multiple simultaneous human subjects research studies.
• Facilitates startup tasks from initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation.
• Acts as primary contact and/or liaison for study startup between investigators, sponsor representatives, and study staff/coordinators.
• Relays timely information to and between appropriate stakeholders.
• Drafts regulatory documents and completes forms/paperwork.
• Collaborates with study coordination team and campus resources to develop source and essential documents (e.g., ICFs, CRFs, nursing orders, treatment plans, etc.)
• Ensures completion of ISF prior to study activation.
• Schedules and facilitates Pre-Site Selection Visits and Site Initiation Visits, and internal meetings related to site activation.
• Tracks startup progress and collaborates with CReST leadership on study startup metrics reporting and timelines to support efficiency and continuous improvement efforts.
• Shepherds startup projects to completion, exercising independent critical thinking and problem solving and engaging key collaborators to ensure the successful and efficient initiation of studies supported by CReST. This may include designing new pathways or procedures to operationalize complex protocols.
• Under the direction of the Startup Manager, assists with developing clinical trial budgets and identifying pricing for various procedures.
• Facilitates new study intake and services agreement development for applicable CReST request.
• Develops or assists with developing standard operating procedures (SOPs) and Work Instructions for startup-related tasks.

Regulatory & Coordination (20%)

• Acts as a backup study coordinator for CReST protocols during slow startup times or busy coordination times. This effort will fluctuate depending on bandwidth.
• Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies for ongoing CReST studies, as needed.
• Assists study coordinators with complex protocol amendments including changes to schedule of events.
• Assures compliance with applicable regulations (FDA; OHRP, etc.), external and internal policies (NIH; CU and hospital affiliates, IRBs, etc.) departmental Standard Operating Procedures (SOPs), and research standards and best practices (ICH Good Clinical Practice (GCP), and Good Documentation Practices (GDP), etc.)

Other (10%)

• Accurately tracks billable time by study, targeting an average of ~25 billable hours per week across all studies.
• Assists with team or institutional process improvement or educational initiatives related to startup.
• Provides excellent customer service to both internal and external stakeholders, presenting a positive image of the department and University.
• Other duties, as assigned by manager.

Work Location: Onsite – this role is expected to work onsite and is located in Aurora, Colorado.