Sports Clinical Research Coordinator

University of Utah•Salt Lake City, UT

20d•$55,000 - $67,000•Onsite

About The Position

Clinical Research Coordinators (Non-R.N.) Coordinates the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred. Departments may require IRB CITI Course or IATA DGR training within a specified timeframe. Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification. This position is patient-sensitive and must fulfill all associated vaccination requirements, or be approved for an exemption, prior to the first day of work. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Learn more about the great benefits of working for University of Utah: benefits.utah.edu The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget.

Requirements

EQUIVALENCY STATEMENT : 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).
Clinical Research Coordinator (Non-R.N.), II: Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
Clinical Research Coordinator (Non-R.N.), III : Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience.

Nice To Haves

Problem Solving
Incumbents are responsible for coordinating the daily operations of their assigned research team, coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives.

Responsibilities

Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance.
Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting, subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
Recognizes, tracks and reports adverse events and protocol deviations.
Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
Represents the research program at meetings, national and international research consortia.
Prepares, submits and maintains 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.
Supervises, mentors and trains new or junior research staff.
Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.
Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.
Assists the Principal Investigator in the development of study protocols
Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs), study protocols, and applicable regulations.
Implement processes and organize efforts within study team to achieve objectives, coordinating research procedures, study visits, and follow-up care.
Create and maintain tools and documentation to track study metrics, providing updates to management.
Conduct pre-study, site qualification, study initiation, monitoring visits, and close-out activities.
Maintain source documents and report adverse events.
Recruit, screen, enroll, and obtain consent from study participants.
Collect and maintain patient and laboratory data.
Work directly with study participants and families and serve as project liaison to other departments, outside organizations, and government agencies.