What are the responsibilities and job description for the Clinical Research Regulatory Specialist position at Herman Ostrow School of Dentistry of USC?
This is a full time staff position with an annual compensation of $75,968.95/year.
We are seeking a clinical research regulatory specialist to assist with the development and management of an NIH RF1-grant funded clinical trial in which individuals with stroke will be enrolled and participate in study activities over the course of one year.
- The candidate will manage and support day-to-day clinical research operations, including participant recruitment, scheduling, data collection, study visit coordination, data entry and verification, staff training, and communications.
- The candidate will also oversee laboratory resource utilization by overseeing supply procurement, inventory control, and general clinical laboratory safety.
- The candidate will also maintain complete and accurate clinical research records, study files, training records and laboratory documentation, ensuring all activities comply with federal and institutional guidelines.
Minimum Education: Bachelor's degree Additional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Additional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype). Preferred Education: Bachelor's degree or Masters degree in a life science field or related, with specific experience in clinical research and lab management. Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research.
Salary : $75,969