Clinical Research Specialist 2

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Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the Suicide and Trauma Reduction Initiative within the Division of Risk and Resilience in the Department of Psychiatry and Behavioral Health; 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 administration of psychological assessments (e.g., SCID, DIAMOND, and CAPS-5); tracking of participant movement through clinical trials using Ripple and REDCap; and 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.

Minimum Education Required:

Bachelor's Level Degree or equivalent combination of education and experience with a Major in biological sciences, health sciences or medical field.

Required Qualifications:

Bachelors 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 specialty area 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. Experience with clinical trial software such as Ripple and REDCap preferred. Masters Degree in a related health sciences or medical field desired. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

At The Ohio State University, through reflection, evaluation and meaningful action, we aim to reinforce our ethical culture and live shared values to advance our core work of teaching, learning, research and service. Our shared values are: Excellence and Impact, Diversity and Innovation, Inclusion and Equity, Care and Compassion and Integrity and Respect.

Function: Research and Scholarship

Sub Function: Clinical Research

Career Band: Individual Contributor Series-Specialized

Career Level: S2

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 and fulfilled for participants to receive patient care services according to protocol; coordinates scheduling and follow-through of surgeries, medical procedures, & other diagnostic testing; collects and documents medical histories; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; tracking of participants through Ripple and REDCap; 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.

Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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