Clinical Research Coordinator-Endocrinology, Diabetes and Metabolism

The Ohio State University

4d•Onsite

About The Position

Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer Clinical Trials Management Organization for the Division of Endocrinology, Diabetes and Metabolism; assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols; recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care; documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data; generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.

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.
Computer skills.
Successful completion of a background check.

Nice To Haves

Knowledge of medical terminology.
Clinical research certification from an accredited certifying agency.
Experience using Microsoft Software applications.
Pre-employment physical, including a drug screen may be required.

Responsibilities

Coordinate and perform daily clinical research activities in accordance with approved protocols.
Assess patient records to identify eligible participants.
Recruit, interview, and enroll patients.
Obtain informed consent and ensure compliance with regulatory and sponsor requirements.
Educate patients and families about the study.
Coordinate patient care appointments, procedures, and diagnostic testing.
Collect, process, and evaluate biological samples.
Administer and evaluate standardized scoring of tests or questionnaires.
Monitor patients for adverse reactions and notify appropriate personnel.
Document unfavorable responses and notify research sponsors and regulatory agencies.
Evaluate patients for protocol compliance.
Collect, extract, code, and analyze clinical research data.
Generate reports and review for data validity.
Ensure compliance with IRB, FDA, federal, state, and industry sponsor regulations.
Coordinate and prepare for external quality assurance and control reviews.
Participate in developing new research protocols and establishing study goals.