The Clinical Research Coordinator III (CRCIII) is to assist research nurses and/or independently coordinate Phase I-III therapeutic and non-therapeutic adult clinical research for local investigator initiated and pharmaceutical sponsored trials. A CRC III ensures patient safety, protocol compliance and data integrity. Maintain a current and working knowledge of Cardiology Disease and their relative standard of care treatment and clinical research. Maintain a current knowledge and apply all recognized ICH Good Clinical Practice (GCP) Standards, Code of Federal Regulations and Health Insurance Portability and Accountability Act (HIPAA) regulations to the conduct of Cardiology Clinical trials. Train and mentor new staff members.
(40%) Participant Coordinator -Independently coordinate registry and/or non-therapeutic trials or work closely with nurse coordinator or PI for coordination of therapeutic trials. • Maintain or establish an understanding of assigned trials and their clinical diagnosis and standard of care for that particular disease process • Initiate and execute start-up activities, regulatory knowledge and requirements, as well as IRB guidelines. • Follow and apply protocol guidance and good clinical practice for participants in clinical trials to ensure safety and efficacy • Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures independently. • Assessing participant eligibility and recruitment related activities as per protocol specific guidelines. • Provide each trial with protocol required coordination and scheduling procedures for screening and randomization and enrollment. • Provide ongoing participant coordination while in study, tracking visits, scheduling, OnCore, REDCap or data management system, EPIC and other platforms required for the management of participants in clinical trials. • Identify, assess, and report to the PI and sponsor adverse events • Communicate significant changes in participant status with appropriate staff and manage as directed • Oversee and maintain study/regulatory documentation • Schedule and conduct study monitor visits as directed by study sponsor. • Participates in the development of data collection tools • Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks. • Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials and remain eligible for continued participation • Identifies and procures equipment and supplies needed to fulfill project requirements • Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures. • Ability to handle multiple priorities and deadlines and troubleshoot and resolve problems
(35%) Data management • Complete electronic case report forms (eCRFs) in protocol database for trials, either by abstracting from medical records or other source provided in order to ensure accurate and complete data. • Maintain knowledge of medical terminology, critical lab values, medical conditions and adverse event criteria and terminology. • Respond to monitor issues queries in a timely manner. Facilitate monitoring visits/audit activities including scheduling, EPIC access, and IDS visits. • Maintain understanding and technical capability of the various sponsor electronic data capture systems to ensure complete, accurate, timely submissions and quality data for each assigned trial. • Maintain study files and subject documents for each trial that is organized, accessible and retrievable. • Enter patient registration and visit dates in various internal databases (Oncore). • Document patient related visits in medical chart as necessary. • Review patient charts and records to abstract appropriate research related information. • Site data manager and staff contact for issues arising with data management or entry. • Maintain working knowledge of various sponsor specific databases and portals.
(15%) CRC - Assist nurse coordinator with completion of non-nursing study procedures on therapeutic trials or varying complexity and acuity (i.e. stem cell trials) • Provide support and collaborate to complete non-nursing activities for participants. • Maintain a working knowledge of patient eligibility and protocol specific requirements. • Perform non-nursing study visit activities (perform EKG, lab collection/processing/shipping, patient questionnaires). Maintain a working knowledge of study specific procedures. • Collect/obtain samples or imaging to be sent to study sponsors. • Act as a secondary informational source for assigned trials to field protocol questions or potential and enrolled study subjects. • Participate in consenting/screening process with research coordinator and PI. Participate in recruitment and pre-screening efforts to promote trial enrollment and accrual. • Assist with other documentation as directed. • Provide back up support for nurse coordinator as appropriate when coordinator is unavailable. • Facilitate physician review of study specific lab reports and patient assessments.
(10%) Independent projects • Mentor and train new CRC's • Interview and provide feedback on new LCRU staff candidates. • Manage additional work load and trials during staffing changes. • Provide process improvement and CRC perspective for work flow improvement. • Complete special data management requests and special projects as assigned.
Required Qualifications: ( Must be documented in application materials) • BA/BS in a scientific or health related field plus 4 years clinical research experience or an advanced degree and 2 years’ experience or a combination of education and experience in clinical research to equal to eight years. • Experience with data abstraction and management • Experience with Epic or similar electronic medical record system • Experience with recording data in electronic case report form systems. • Clinical Research certification or equivalent
Preferred Qualifications: • Cardiology experience in a clinical or research setting • Experience with Word, Outlook, and web based systems for tracking activities, calendaring, and retrieving/updating information. • Proficient in Good Clinical Practices (GCP’s) • Detail oriented with exceptional organizational, planning, and problem solving skills • Ability to work independently, as part of a team, and with changing priorities • Excellent written, verbal and interpersonal skill • Ability to lead and execute initiatives • Ability to mentor and train CRCs level I and II
Internal Number: 340190
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.