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, interviewing, and enrolling patients. The coordinator will manage the informed consent process, ensuring compliance with regulatory and sponsor requirements, and educate patients and families about the study's purpose, goals, and processes. Responsibilities include coordinating patient appointments, procedures, and diagnostic testing, as well as collecting, processing, and evaluating biological samples. The role also entails administering and evaluating standardized testing, monitoring patients for adverse reactions, documenting unfavorable responses, and notifying appropriate parties and regulatory agencies. Additionally, the coordinator will assist in evaluating patient compliance, collecting, extracting, coding, and analyzing clinical research data, generating reports, and supporting activities to ensure compliance with Institutional Review Boards (IRB), FDA, federal, state, and industry sponsor regulations. The position also involves preparing for external quality assurance reviews and contributing 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 required.
One year experience in a clinical research capacity required.
Requires successful completion of a background check.
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 desired.
Clinical research certification from an accredited certifying agency desired.
Computer skills required with experience using Microsoft Software applications desired.
Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

Responsibilities

Coordinate and perform daily clinical research activities in accordance with approved protocols.
Assist with assessing patient records to identify eligible participants.
Recruit, interview, and enroll patients into clinical research studies.
Obtain informed consent and ensure compliance with regulatory and sponsor requirements.
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 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.