Clinical Research Coordinator-Clinical Trials Management Office
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 according to study protocols, and participate in the collection, processing, and evaluation of biological samples. Responsibilities also include administering and evaluating standardized tests, monitoring patients for adverse reactions, documenting and reporting unfavorable responses to sponsors and regulatory agencies, and evaluating patient compliance with protocols. The role supports data collection, extraction, coding, and analysis, generating reports to ensure data validity. Additionally, the coordinator will ensure compliance with Institutional Review Boards (IRB), FDA, federal, state, and industry sponsor regulations, assist with preparing for external quality assurance reviews, and contribute 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 required.
- Requires successful completion of a background check.
- Requires a valid driver's license or reliable transportation.
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.
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.
- Participate in evaluating 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.
Benefits
- The university is an equal opportunity employer, including veterans and disability.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
