Clinical Research Specialist 2
About The Position
Clinical Research Specialist to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the Department of Psychiatry; 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; participates in the collection of MRI data; collection of EEG data; collection of EKG data; 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; collects, processes and stores/transports clinical research specimens in the clinical research lab; 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.
Requirements
- Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
- 1 year of relevant experience required.
- Requires successful completion of a background check.
Nice To Haves
- 2-4 years of relevant experience preferred.
- Experience or knowledge in psychiatry 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
Responsibilities
- coordinate and perform daily clinical research activities in accordance with approved protocols administered by the Department of Psychiatry
- 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
- participates in the collection of MRI data
- collection of EEG data
- collection of EKG data
- 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
- collects, processes and stores/transports clinical research specimens in the clinical research lab
- 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
Benefits
- Eligible Ohio State employees receive comprehensive benefits packages, including medical, dental and vision insurance, tuition assistance for employees and their dependents, and state or alternative retirement options with competitive employer contributions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
