Clinical Research Startup Specialist
Found in: Talent US C2 - 2 weeks ago
Description
University of Colorado Anschutz Medical Campus
Department: Clinical Research Support Team (CReST) - OVCR
Job Title:Clinical Research Startup Specialist
Position #: 00821154– Requisition #: 33101
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 drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals.
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.
We are seeking an individual who is collaborative, communicative, caring, detail oriented and organized, proactive, able to think critically, focused on quality, passionate about research, dedicated to personal growth, and highly motivated in all areas of study coordination.
Key Responsibilities:
Study Startup 45%
Independently manages with minimal supervision study startup projects and activities for multiple simultaneous human subjects research studies. Oversees startup tasks from initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation. Proactively seeks guidance and engages stakeholders to problem solve and push forward startup activities efficiently to meet sponsor timelines. Delegates startup tasks to other assigned team members and/or leadership to efficiently execute and meet timelines and milestones. Oversees and verifies completion of delegated startup tasks (e.g., source document creation, ICF edits, regulatory binder assembly, IRB submission, budget development, etc), and advises CReST management on startup needs and performance. Completes and manages regulatory submissions to local and central IRBs, FDA, and other regulatory agencies. Drafts regulatory documents and completes forms/paperwork. Fields questions and provides study-specific updates related to regulatory submissions and progress. Exercises independent critical thinking and decision making to ensure the successful initiation of studies supported by CReST. 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.)Customer Service 20%
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. Provides excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University.Process Development and Continuous Improvement 15%
Tracks startup progress and collaborates with CReST leadership on study startup metrics and timelines to support efficiency and continuous improvement efforts. Establishes relationships with clinic, pharmacy, lab, and hospital stakeholders, and regularly communicates with these entities in order to operationalize complex clinical trials. Develops standard operating procedures (SOPs) and work instructions for startup-related tasks. Collaborates with key stakeholders on institutional process improvement initiatives related to startup.Training and Education: 10%
Develops and presents educational materials to the CReST team and/or CU research community. Trains and mentors intermediate and entry level coordinators and serves as a reference point within CReST for questions and guidance related to study startup. Acts as a subject matter expert in startup processes.Other 10%
Accurately tracks billable time by study, targeting ~25 billable hours per week across all studies. Other duties, as assigned by manager.Work Location:
Onsite – Work in person with the ability to work remote 1 day a week as work permits
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