"Research Professional 2 – Research Coordinator"

Responsibilities

• Serve as liaison with clinics and offices to facilitate recruitment
• Organize and maintain subject identification, recruitment, enrollment, and retention, including follow-up calls
• Obtain data and accurately transit to appropriate database
• Maintain source documents
• Organize, prioritize, and accomplish daily tasks related to anesthesiology protocols
• Identify and assess adverse events; responsible for subject protocol triage and symptom management; report adverse events in a timely fashion
• Assist in analysis of results; assist with development and submission of abstracts and publications
• Act as resource for protocol development, statistical design and budget preparation
• Translate protocol required activities into flow sheets and patient care orders

Subject and Data Management (60%)

Regulatory Management (20%)

• Support all aspects of human subject protection regulations: complete required IRB regulatory documentation, manage all IRB submissions and correspondence in conjunction with PI
• Track and maintain all binders and regulatory documents
• Prepare for and participate in site initiation visits, monitoring visits, regulatory audits, etc.

Administration (20%)

• Maintain departmental research database; obtain and publish updates of study progress
• Coordinate site visits, audits

Required Qualifications

• BA/BS in health-related field plus 2 years experience of relevant research experience or a combination of education and research experience totaling 6 years
• Experience recruiting, consenting and interacting with human research subjects, proven ability to recruit/retain subjects
• Experience with paper and computerized clinical case report forms and data collection; experience with research databases and study spreadsheets
• Knowledge of Good Clinical Practices and federal regulations related to clinical research, including knowledge of adverse event reporting
• Computer proficiency and ability to navigate multiple software applications
• Ability to work flexible hours as required to recruit and enroll research subjects
• Ability to organize and manage several protocols concurrently
• Ability to prioritize tasks
• Meticulous attention to detail

Preferred Qualifications

• Experience and proficiency with protocol development, including basic statistical concepts (sample size calculation, alpha and beta error, etc.)
• Experience with research database software including REDCap, Oncore, Epic, and Microsoft Access
• Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies
• Experience with IRBs
• Familiarity with the University of Minnesota Medical Center-Fairview hospital and clinics
• Experience with anesthesiology and phlebotomy