Clinical Research Coordinator

Summary

The Ohio State University is seeking a Clinical Research Coordinator within the Medicine | Psychiatry department. The role coordinates and performs clinical research activities, including participant recruitment and consent, patient scheduling and care coordination, data collection and analysis, protocol development, regulatory compliance, and research reporting.

Responsibilities

• 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; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires – (also remove any type of test or questionnaire that is not applicable; for example, if administering and scoring behavioral questionnaires, but not diagnostic or psychological tests, then only include description about the behavioral tests); 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
• 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
• 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
• 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
• Attends departmental meetings; attends national professional and scientific conferences to continue professional development; completes special projects as required
• Collecting and organizing data

Skills

• Bachelor's Degree in Biological Sciences, Health Sciences or medical field, or equivalent combination of education experience required
• 0 years of relevant experience required
• 2-4 years of relevant experience preferred

Qualifications

Must Haves

• Bachelor's Degree in Biological Sciences, Health Sciences or medical field, or equivalent combination of education experience required
• 0 years of relevant experience required

Nice to Haves

• 2-4 years of relevant experience preferred