Professional Research Associate

About the role

Under the supervision of the Principal Investigator and/or Program Manager, the Professional Research Associate is responsible for executing day-to-day operations and study coordination for research, evaluation and implementation projects within the Denver Veteran’s Health Administration.

Responsibilities

• Perform a variety of duties to support the organization’s medical and health science research programs.
• Execute a variety of administrative duties to maintain specialized clinical research data and implement study design which may include the following aspects of clinical trials: submission to regulatory boards for study approval and site initiation; subject recruitment, enrollment and retention; and appropriate data collection and management.
• May assist with fiscal negotiations under management oversight.
• Develop and submit regulatory packages to regulatory bodies (PRMS, VA RDC and study-specific IRBs including COMIRB, NCI, CIRB, and other external IRBs).
• Set up and maintain study records in accordance with study design and regulatory rules (VA R&D, COMIRB reporting, e.g.) across study lifecycles.
• Ensure accurate, timely reporting of relevant research-related events (AEs, UAPS, PDs, e.g.).
• Screen and evaluate candidates for clinical studies.
• Screen and assess candidates for projects of limited complexity.
• Use objective ratings techniques (inclusion/exclusion criteria) to identify potential candidates for participation