Job Description

• Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems.
• Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for clinical research functions and research project goals.
• Helps prepare and conduct high-quality compliance reviews, including close-out and reporting.
• Updates all databases, and regulatory binders with information pertinent to studying milestone progress.
• Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.
• Performs IND/ANDA submissions
• Researches new and updates rules and regulations associated with clinical research
• Reports weekly process to Director or Research and study principal investigators

"USC is an equal opportunity, affirmative action 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 will consider for employment all qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring ordinance."

Minimum Education:
Bachelor's degree
Combined experience/education as substitute for minimum education

Minimum Experience:
2 years
Combined education/experience as substitute for minimum experience

Minimum Field of Expertise:
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 (ICH-GCP), 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 diverse 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).


PI116282466