Clinical Research Regulatory Specialist

University of Southern California • Los Angeles, CA

7d • 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. 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.

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

• Bachelor's degree or Masters degree in a life science field or related, with specific experience in clinical research and lab management.
• 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector
• 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.

Benefits

• USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy.
• USC observes affirmative action obligations consistent with state and federal law.
• USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety.
• We provide reasonable accommodations to applicants and employees with disabilities.
• Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at [phone], or by email at [email protected] . Inquiries will be treated as confidential to the extent permitted by law.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level