The Ohio State University's Department of Emergency Medicine is looking to solve the problem of coordinating and performing daily clinical research activities in accordance with approved protocols.
Requirements
- knowledge of clinical research protocols
- experience with electronic data capture systems
- familiarity with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations
- ability to collect, extract, code, and analyze clinical research data
- experience with generating reports and reviews to ensure validity of data
- knowledge of quality assurance and control reviews by IRB, federal or industry sponsors
- experience with developing new research protocols and contributing to establishment of study goals to meet protocol requirements
Responsibilities
- 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
- 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 questionnaires
- assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response
Other
- final candidates are subject to successful completion of a background check
- a drug screen or physical may be required during the post offer process
- must be able to work varying shifts
- must be able to maintain confidentiality and handle sensitive information
- must have excellent communication and interpersonal skills