Position Purpose
This position is responsible, in collaboration with the Clinical Research Coordinators, Research Nurses, Study Principle 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 Associate 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 Research Office.
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 Associate in coordination with the Renown Research Office and assigned department(s). This position does provide patient care.
Disclaimer
The foregoing description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills and efforts or work conditions associated with the job. It is intended to be an accurate reflection of the general nature and level of the job.
Minimum Qualifications
Requirements - Required and/or Preferred
Name
Description
Education:
Must have working-level knowledge of the English language, including reading, writing and speaking English. High School Graduate or equivalent required. Some college classes preferred.
Experience:
Previous experience with patient care and/or research protocols preferred. Demonstrated experience in prioritizing and organizing work preferred.
License(s):
Ability to obtain Office Laboratory Assistant credentialing following job-specific training within 6 months of hire.
Certification(s):
AHA BLS certification is required within 90 days of hire.
Human Subject Protection Certificate and GCP Training Certificate required within 90 days or hire.
IATA certification required within 90 days or hire.
Phlebotomy certification (CLA - Certified Lab Assistant) or comparable training with phlebotomy in the scope of practice (Medical Assistant, etc.) within 1 year.
CCRP and/or CCRC preferred.
Computer / Typing:
Must be proficient with Microsoft Office Suite, including Outlook, PowerPoint, Excel, 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.