Clinical Research Coordinator-Clinical Trials Management Office

The Ohio State University • Hilliard, OH

1d • Onsite

About The Position

The Clinical Research Coordinator will coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Gastro/Hepatology/Nutrition Division in the Department of Internal Medicine, focusing on Inflammatory Bowel Disease (IBD) clinical research studies. This role involves assisting with patient record assessment for eligibility, recruiting and enrolling patients, obtaining informed consent, and educating patients and families about study purposes and processes. The coordinator will manage patient appointments, procedures, and diagnostic testing, collect and process biological samples, administer and evaluate testing, and monitor patients for adverse reactions, documenting and reporting any unfavorable responses. Additionally, the position supports data collection, extraction, coding, and analysis, generates reports for data validity, and ensures compliance with Institutional Review Boards (IRB), FDA, federal, state, and industry sponsor regulations. The role also assists in preparing for external quality assurance reviews and contributes to the development of new research protocols and study goals.

Requirements

• Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience.
• One year experience in a clinical research capacity.
• Requires successful completion of a background check.
• Patient facing position and staff are required to be on site.
• A valid driver's license or reliable transportation will be needed as there may be some travel to other locations in the Columbus Metropolitan Area.

Nice To Haves

• Experience or knowledge in inflammatory bowel diseases such as Crohn's.
• Knowledge of medical terminology.
• Clinical research certification from an accredited certifying agency.
• Computer skills with experience using Microsoft Software applications.

Responsibilities

• Coordinate and perform daily clinical research activities in accordance with approved protocols.
• Assist with assessing patient records to identify eligible participants for clinical research protocols.
• Recruit, interview, and enroll patients into clinical studies.
• Obtain informed consent and ensure compliance with regulatory and sponsor requirements for the consent process.
• Educate patients and families on the purpose, goals, and processes of clinical studies.
• Coordinate scheduling and follow-through of patient care appointments, procedures, and diagnostic testing.
• Participate in the collection, processing, and evaluation of biological samples.
• Administer, evaluate, and calculate standardized scoring of diagnostic, psychological, or behavioral testing or questionnaires.
• Monitor patients for adverse reactions to study treatment, procedure, or medication and notify appropriate clinical professionals.
• Document unfavorable responses and notify research sponsors and applicable regulatory agencies.
• Evaluate patients for compliance related to protocol.
• Assist with collecting, extracting, coding, and analyzing clinical research data.
• Generate reports and review them to ensure data validity.
• Support activities to ensure compliance with all Institutional Review Boards (IRB), FDA, federal, state, and industry sponsor regulations.
• Assist with coordinating and preparing for external quality assurance and control reviews.
• Participate in activities to develop new research protocols and contribute to the establishment of study goals.

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level