Clinical Research Coordinator

Overview

Clinical Research Coordinator (Non-R.N.) — The University of Utah College of Health and Department of Physical Therapy & Athletic Training is seeking an individual to support clinical research studies evaluating rehabilitation interventions for persons with chronic pain that use telehealth. The successful applicant will interact with patients by phone or video call throughout the state of Utah, and with other research staff members and investigators.

Because of the patient population involved in this study, the person in this position should be able to communicate fluently in both Spanish and English.

• Oversee, assess and ensure participant safety and strict protocol implementation/adherence; oversee compliance with GCP guidelines, federal regulations, institutional policies and procedures, and internal SOPs.
• Evaluate processes to identify obstacles to successful recruitment and retention of study participants. Recommend and implement innovative approaches to maximize enrollment and optimize subject retention.
• Analyze study monitoring and operational reports to monitor production and data collection events; evaluate progress towards meeting required timelines and data collection tasks.
• Implement procedures to prevent future events, including staff education and retraining
• Prepare for and coordinate site visits made by sponsors or federal agencies during course and at the close of the study.
• Represent the research program at meetings, national and international research consortia as needed.
• Prepare, submit and maintain IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• Develop training and staff certification materials, procedures and requirements. Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study. Assist with training team members across the entire spectrum of research studies to include, but not limited to: protocol requirements, schedule of visits, recruitment plan, execution of research plan, collecting adverse event information, maintaining study subject documentation.
  
  Maintain records and other documentation of training.
• Help develop applicable data management queries and oversees data cleaning activities.
• Determine subject population availability, develop recruitment, informed consents and screening materials; help develop survey and study data collection instruments
• Evaluate new protocols for feasibility. Thoroughly review study protocols and map process and data flow to predict areas of vulnerability. Identify, recommend and implement solutions to address such vulnerabilities in specific trials and across the team's study portfolio.
• Coordinate approval of new study agreements and contracts; assists in the development of case report forms.
• Develops QA/QC processes and conduct quality control activities (field/study visits, data queries)
• Determine study visit and site/clinic work flows for studies/protocols
• Work with data managers to help design, develop and test appropriate informatics tools to meet study data, participant and sample tracking needs
• Helps to develop standard operating procedures
• Participates in abstract and manuscript preparation.

The incumbent decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved. The incumbent functions independently under minimal supervision, following FDA, Good Clinical Practice, IRB, NIH, NCI, NSF and/or other regulatory agency guidelines and seeking counsel from the Principal Investigator as necessary.

The incumbent is responsible to organize coverage when not present to ensure protocol requirements are followed.

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of…