The Pediatric Clinical Research Unit (PCRU) at Washington University in St. Louis seeks to solve the problem of effectively managing and overseeing clinical research studies, ensuring compliance with regulatory standards, and providing leadership to clinical research staff.
Requirements
- Basic Life Support certification must be obtained within one month of hire date.
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
Responsibilities
- Provide leadership to PCRU staff acting as the Research Coordinator for Investigator Initiated and Industry Sponsored Clinical Research studies carried out by Principal Investigators.
- Works with PI to perform research protocol. Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
- Assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
- Serves as a resource to the clinical research staff, ensuring appropriate procedures and explains policies and procedures; ensures that research projects are completed according to IRB and federal guidelines.
- Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in the hiring, training and evaluation of clinical research staff.
- Provides Study Coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection and the management of data generated by study protocols.
- Researches and recommends new methods and procedures to maintain standards and improve quality.
Other
- Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
- Clinical Or Research (4 Years), Supervisory (1 Year) Work Experience.
- Skills: Analytical Thinking, Clinical Research, Interpersonal Communication, Leadership, Oral Communications, Prioritization, Problem Solving, Written Communication.
- A driver's license is not required for this position.
- All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position.
