Clinical Research Regulatory Specialist

University of Southern California•Los Angeles, CA

9d•Onsite

About The Position

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.

Requirements

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).

Nice To Haves

Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials.
Advanced knowledge of regulations governing human research.

Responsibilities

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.
Oversee laboratory resource utilization by overseeing supply procurement, inventory control, and general clinical laboratory safety.
Maintain complete and accurate clinical research records, study files, training records and laboratory documentation, ensuring all activities comply with federal and institutional guidelines.