Clinical Research Monitor I

Clinical Research Monitor I-34812University Staff

Description

University of Colorado Anschutz Medical Campus

Department : Clinical Research Support Team (CReST)

Job Title : Clinical Research Monitor I

Position # : 827305 Requisition # : 34812

Job Summary :

The full time Clinical Research Monitor Iwill be a key member of the Clinical Research Support Team (CReST). This position will focus on clinical monitoring and providing direct monitoring services for investigator-initiated studies, particularly those studies where the local researcher is the sponsor / IND holder.

This position may also act in a clinical research coordinator role or help build case reports forms in an Electronic Data Capture (EDC) system to support the workload of the CReST team.

Key Responsibilities :

Clinical Research Monitoring : 70%

• Monitors data, regulatory, and protocol compliance through routine and for-cause or by request monitoring activities both in person and remotely.
• Develops risk-based monitoring plans based on the complexity of the study.
• Develops study-specific budgets for Clinical Monitoring and related services.
• Works with sites and investigators to schedule and conduct monitoring visits (Site Initiation, Interim, For-Cause / by request, and Close Out Visits)
• Develops training materials for Site Initiation Visits (SIVs) and documents protocol and GCP trainings.
• Develops visit agendas and follow up reports of visit findings. Disseminates reports to the study’s principal investigator (PI) and other key stakeholders.
• Ensures quality of study data through source data verification and reconciliation.
• Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), and other pertinent regulatory agencies.
• Under the direction of the CReST Program Director and as directed by senior monitoring staff, Collaborates to identify and take on monitoring projects and coverage within the Monitoring team.
• Assists with the development of eCRFs, EDC calendars or other appropriate database resources for data capture.

Communication : 20%

• Relays timely information to PI’s, study staff, CReST leadership and other key stakeholders
• Collaborates with team members and external stakeholders, maintaining strong relationships and communication between groups.

Other : 10%

• Accurately tracks billable time in support of CReST program and financial goals.
• May provide regulatory support for clinical trials, including QA / QC reviews, submissions to institutional groups, IRBs and FDA on an as needed basis.
• If needed, may assist with clinical research coordination tasks for industry, federal or locally funded clinical studies.
• Other duties as assigned by manager

Work Location :

Onsite this role is expected to work onsite and is located in Aurora, CO.

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