Clinical Research Coordinator I

The posted pay range represents the long-term earning opportunity for the position, while starting pay is based on the experience, skills, and qualifications each candidate brings to the role.

Purpose:

This position is responsible, in collaboration with the other research personnel and the Study Principal Investigators (PIs), for the coordination and management of all research activities as part of the clinical research team at Renown Health under the direction of the research area's Supervisor and the Manager of Clinical Research. This position assists with the drafting, completing, and submitting of protocol applications as specified by the IRB. The Clinical Research Coordinator I collects and submits participation data and monitors study compliance. This includes coordination of care for research participants being screened and enrolled into clinical trials, drug accountability, regulatory activities, research billing compliance, and overall management of the participants' activities throughout the term of research studies from feasibility determination and study start-up through study close-out. Further, this position requires the incumbent to function as an integral part of the research and care teams, working with colleagues to meet deadlines and the needs of patients, the specialty area, and the Office of Clinical Research.

Nature and Scope:

This position is challenged to maintain research protocols with an extremely high degree of accuracy. The incumbent must be highly organized and have good interpersonal skills to communicate with physicians and physician staff. This position prepares, submits, and monitors documentation of research studies while assuring compliance with regulations and protocols. Performs assigned clerical and technical duties as directed. Clinical duties, including but not limited to scheduling and consenting participants, escorting participants from the waiting room to the exam room promptly, taking vital signs per guidelines, completing study assessments per guidelines, and preparing lab specimens for processing. In addition, this position is responsible for maintaining research study Clinical Trial Management System (CTMS), clinical trial data management, and eRegulatory documentation at audit-ready standards from protocol identification through study close-out. Completes other work as required.The position is challenged to manage a large volume of items while maintaining a high degree of accuracy and efficiency with significant attention to detail. Working knowledge of all regulatory requirements governing IRB guidelines. The position requires strong decision-making, independent judgement, and analytical skills in order to apply federal and state regulations to a variety of situations.Serves as a Clinical Research Coordinator I in coordination with the Renown Office of Clinical Research and assigned department(s).This position does provide patient care

Minimum Qualifications: Requirements - Required and/or Preferred

Name

Description

Education:

Ability to read, write, speak, and understand English sufficiently to perform job duties safely and effectively. Associate's degree required; OR High School Diploma/GED and two (2) years of clinical, healthcare, research, regulatory, laboratory, or data management experience may substitute for associates degree.

Experience:

One (1) year of clinical, healthcare, research, regulatory, laboratory, or data management experience required. Demonstrated ability to prioritize and organize work.

License(s):

Ability to obtain Office Laboratory Assistant credentialing application must be submitted to the state within six (6) months of hire.

Certification(s):

Phlebotomy certification (CLA) or equivalent clinical training within one (1) year of hire. Human Subject Protection Certificate within 90 days of hire. Good Clinical Practice (GCP) Training Certificate within 90 days of hire. IATA certification within 90 days of hire. BLS certification within 90 days of hire. CCRP, CCRC, SoCRA, or ACRP preferred.

Computer / Typing:

Must be proficient with Microsoft Office Suite, including Outlook, PowerPoint, Excel, Teams, and Word and have the ability to use the computer to complete online learning requirements for job-specific competencies, access online forms and policies, complete online benefits enrollment, etc.

Disclaimer:

The foregoing description is not intended to be, and should not be construed as, an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job.