Clinical Research Coordinator I

Renown Health • Reno, NV

3d

About The Position

The Clinical Research Coordinator I coordinates and manages research activities as part of the clinical research team at Renown Health, in collaboration with research personnel and Study Principal Investigators, and under the direction of the research area's Supervisor and the Manager of Clinical Research. The role supports clinical trials from feasibility and study start-up through close-out, including participant coordination, regulatory documentation, protocol compliance, drug accountability, research billing compliance, and study data management. The position assists with drafting, completing, and submitting protocol applications as specified by the IRB, and collects and submits participation data while monitoring study compliance.

The coordinator works as an integral member of research and care teams to meet deadlines and the needs of patients, the specialty area, and the Office of Clinical Research. The work requires maintaining research protocols and documentation with a high degree of accuracy, organization, efficiency, and attention to detail. The role prepares, submits, and monitors study documentation to ensure compliance with regulations and protocols, and performs assigned clerical and technical duties.

Clinical duties include scheduling and consenting participants, escorting participants to exam rooms, taking vital signs and completing study assessments according to guidelines, and preparing laboratory specimens for processing. The position maintains the Clinical Trial Management System (CTMS), clinical trial data, and eRegulatory documentation at audit-ready standards. It requires working knowledge of IRB-related regulatory requirements, strong decision-making, independent judgment, analytical skills, and interpersonal communication with physicians and physician staff. This position provides patient care.

Requirements

• Ability to read, write, speak, and understand English sufficiently to perform job duties safely and effectively.
• Associate's degree; alternatively, a high school diploma/GED and two years of clinical, healthcare, research, regulatory, laboratory, or data management experience may substitute for the associate's degree.
• One year of clinical, healthcare, research, regulatory, laboratory, or data management experience.
• Demonstrated ability to prioritize and organize work.
• Ability to obtain Office Laboratory Assistant credentialing; the application must be submitted to the state within six months of hire.
• Phlebotomy certification (CLA) or equivalent clinical training within one 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.
• Proficiency with Microsoft Office Suite, including Outlook, PowerPoint, Excel, Teams, and Word, and ability to use a computer for online learning, forms, policies, and benefits enrollment.
• Strong organization, attention to detail, interpersonal communication, decision-making, independent judgment, and analytical skills.
• Working knowledge of regulatory requirements governing IRB guidelines.

Nice To Haves

• CCRP, CCRC, SoCRA, or ACRP certification.

Responsibilities

• Coordinate and manage research activities in collaboration with research personnel and Study Principal Investigators.
• Support research studies from feasibility determination and start-up through study close-out.
• Assist with drafting, completing, and submitting protocol applications as specified by the IRB.
• Collect and submit participation data and monitor study compliance.
• Coordinate care and activities for participants being screened and enrolled in clinical trials.
• Manage drug accountability, regulatory activities, and research billing compliance.
• Prepare, submit, and monitor research study documentation for compliance with regulations and protocols.
• Perform assigned clerical and technical duties.
• Schedule and consent participants, escort them to exam rooms, take vital signs, complete study assessments, and prepare laboratory specimens for processing.
• Maintain the Clinical Trial Management System (CTMS), clinical trial data, and eRegulatory documentation at audit-ready standards.
• Work with research and care team colleagues to meet deadlines and the needs of patients, the specialty area, and the Office of Clinical Research.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree