Address
Form of workLocation: Chicago, IL
Hospital: RUSH University Medical Center
Department: Int Med Gastroenterol-Res Adm
Work Type: Full Time (Total FTE between 0. 9 and 1. 0)
Shift: Shift 1
Work Schedule: 8 Hr (8:30:00 AM - 5:00:00 PM)
Summary:
This position supervises Clinical Research Assistants, Associate Clinical Research Coordinators, Clinical Research Coordinators, volunteers, and/or medical students working in the pediatric research areas under the direction of the PIs. The Supervisor works under the general direction of the Research Manager and is responsible for complex research studies. This includes the overall responsibility for preparation, completion, and review of all research studies conducted in the pediatric department at Rush University Children’s Hospital (RUCH), regulatory oversight, onboarding new hires, training, and FDA submissions. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Responsibilities:
•Supervises the study coordinators to ensure all aspects of complex studies, including recruitment, consent, screening, scheduling, and tracking and provides study updates to study participants throughout the conduct of the study.
•Supervises the submission of study related documents, study protocols and study protocol amendments to the IRB per policy and procedure.
•Serves as the primary regulatory contact for studies; ensures that regulatory compliance is met and that regulatory files are audit-ready.
•Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state and federal guidelines and regulations related to Clinical Research.
•Oversees the collection, processing and shipment of potentially biohazardous specimens.
•Supervises the administration of structured tests and questionnaires according to research study protocols including the utilization of study-related technology and equipment as part of assessment procedures.
•Supervisors the implementation of procedures to monitor and audit compliance of operations, adhering to protocol-specific guidelines with standards of Rush University and other outside regulatory bodies including, but not limited to, the United States Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS), and the Office of Human Research Protection (OHRP).
•Ensure unanticipated problems (protocol deviations, adverse events, and serious adverse events) are submitted in a timely manner.
•Provide recommendations to proactively address complex issues and/or variances with study related activities.
•Train and mentor Clinical Research staff members within the department.
•Assist with New Hire onboarding processes by posting open positions in IGREENTREE, interviewing potential candidates, and completing the required paperwork for 90-day reviews.
•Assist with yearly performance evaluations, Human Resource documentation, and disciplinary actions that may need to be addressed.
•Oversees subject management processes in OnCore for Pediatrics.
•Supervises the submission in clinicaltrials.gov website for Pediatrics.
•Maintains current knowledge of industry trends.
Other information:
Required Job Qualifications:
•Bachelor's degree and 6 years of Clinical Research experience OR 10 years of Clinical Research experience.
•2 years as a lead or supervisor experience
•4 years coordinating Human Subjects research.
•Certification as a Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professionals (CIP) is required.
•Detailed knowledge directly related to the application of federal regulations pertaining to human subjects’ protections and Clinical Research.
•Demonstrated advanced knowledge of Good Clinical Practices and Good Documentation Practices.
•Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to Clinical Research.
•Strong project management skills.
•Demonstrated problem-solving, critical decision makings and professional judgement.
•Strong analytical and organizational skills with a high attention to details.
•Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants and vendors.
•Strong verbal and written communication with ability to communicate complex concepts to multiple audiences.
•Demonstrated ability to collaborate within multi-disciplinary team settings.
•Travel may be required.
•Other duties as assigned
Preferred Job Qualifications:
•Bachelor's degree in science or health related field.
•Master’s degree with science or health related field.
•Prior supervisory experience.
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Disclaimer:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements
Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
