OFFICIAL JOB DESCRIPTION TEMPLATE
CLASSIFICATION: CLINICAL RESEARCH COORDINATOR
WORKING TITLE: CLINICAL RESEARCH COORDINATOR
JOB CODE: 3206
PAY BAND: A3
ENFORCED TARGET HIRING RANGE: $42,120/yr to $63,190/yr
Apply here: https://wexnermedical.osu.edu/careers/current-openings/research/449462
Job Description Summary
Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the adult cochlear implant research program at the Department of Otolaryngology - Head and Neck Surgery; 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 biological samples; administers, evaluates and calculates standardized scoring of behavioral testing; 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.
Essential Duties
60%: Implements, coordinates and performs daily clinical research activities in accordance with approved protocols; 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; ensures initial and follow-up appointments are appropriately scheduled according to protocol; coordinates scheduling for multiple research studies; collects and documents medical histories; participates in the collection, & processing biological samples; evaluates and calculates standardized scoring of behavioral testing; ); coordinates and documents care of patients; 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.
15%: Assists with collecting, extracting, coding, and analyzing clinical research data; compiles and enters clinical research data into study database; generates reports and reviews to ensure validity of data; assists with development of clinical research study database; assists with writing sections of manuscripts, articles and other media for publication and presentation.
10%: Participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements; assists with planning and development of clinical study processes.
10%: Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; 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 planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; completes case report forms.
5%: Attends departmental meetings; attends national professional and scientific conferences to continue professional development; completes special projects as required.
Minimum Education and Skills/Experience Required/Desired
Bachelor’s Degree in biological sciences, health sciences or other medical field or an equivalent combination of education and experience required; one year experience in a clinical research capacity required; experience or knowledge in Audiology preferred; knowledge of medical terminology desired; clinical research certification from an accredited certifying agency desired; computer skills required with experience using Microsoft Software applications desired. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.