Clinical Research Point Coordinator – Open Rank Intermediate to Senior

Department: Clinical Research Support Team (CReST) • Position #: 00827546 • Requisition #: 37346

About the role

The Clinical Research Support Team (CReST) has an opening for a full-time Point to Senior Clinical Research Coordinator to provide regulatory, study coordination, and data collection/entry support for a variety of drug, device and biologic studies conducted at the University of Colorado Anschutz Medical Campus and affiliate hospitals. This position may act as lead or co-lead coordinator overseeing coordinating activities for assigned studies, and/or as a primary contact for training and guidance for junior coordinators supporting these studies. This position will have independent decision making and project management responsibilities. Knowledge of Good Clinical Practice and Good Documentation Practices in the context of clinical research 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.

Responsibilities

• Point level – Shepherds and completes study startup activities from initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation to prepare completely for enrollment of the first study subject.
• 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.
• Independently crafts and submits nursing orders for approval.
• Modifies, or supervises modifications of Informed Consent Forms to comply with Institutional guidelines and obtains required approvals.
• Completes and manages regulatory submissions to local and central IRBs, PRMS, and other regulatory bodies. Drafts regulatory documents and completes forms/paperwork. Fields questions and provides study-specific updates related to regulatory submissions and progress.
• Trains and mentors junior staff, and serves as a reference point within CReST for questions and guidance related to their duties and assigned studies.
• Develops protocol-specific systems and documents including process flows, training manuals, source documents, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
• Demonstrates and applies comprehensive working knowledge of applicable regulations, policies and GCP, and advises coworkers and study teams on compliance and application.
• Assists senior staff with more advanced tasks.
• Provides feedback to CReST managers and leadership on billing and invoicing systems and related metrics.
• Senior level only – All entry and mid-level duties.
• Advises investigators on regulatory matters, best practices, and institutional policies. May develop or assist with development of research plans.
• Engages with essential research resource teams on campus, including UCHealth Research Admin, OnCore, pharmacies, labs, and clinics for study planning. Develops working relationships with key contacts to strategize on study startup and implementation.
• Independently project-manages full-service study startup. Negotiates Study Startup Agreements.
• May present on behalf of CReST or studies at University or external events.
• Oversees study closeout and archiving activities.
• Serves as a strategic partner and advisor to CReST leadership on development and implementation of SOPs and other standard work.
• Consult as needed with CReST leadership on the activities, status, metrics, and capabilities of the CReST coordinator program.
• Undertakes special projects in collaboration with teams, supervisors and/or leadership in creating and implementing processes and procedures and quality improvement initiatives related to CReST operational efficiency and the coordinator program.

Qualifications

• Minimum Qualifications: A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 1 year of professional level experience working in human subjects’ research. Applicants must meet minimum qualifications at the time of hire.
• Preferred Qualifications: Previous experience with software programs such as REDCap, OnCore and EPIC are preferred. Experience with University of Colorado Anschutz and/or affiliated Hospital (e.g., UCHealth, CHCO) policies and procedures is preferred. Experience