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Clinical Research Regulatory AdministratorApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA---Health-Sciences-Campus/Clinical-Research-Regulatory-Administrator_REQ20152182/apply) Keck School of Medicine Los Angeles, California

The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is.

JOB SUMMARY: Works closely with the Regulatory Manager III, supporting principal investigators for the Clinical Investigations Support Office. Leads high-quality compliance reviews and coordinates all CISO work to shepherd protocols and open studies in a timely manner. Removes obstacles from study activation, influencing timely Institutional Review Board (IRB) submissions. Liaises with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws, resolving issues and problems, negotiating compromises, and proposing alternatives and recommendations to facilitate and expedite research. Maintains awareness of new and updated rules and regulations, alerting appropriate staff to changes, and ensuring appropriate interpretation and application to new and existing studies and trials.

JOB ACCOUNTABILITIES

• Works closely with the Clinical Research Regulatory Manager, supporting principal investigators for the Clinical Investigations Support Office. Ensures regulatory compliance for multiple clinical trials, Initiating, revising, and overseeing all regulatory aspects of study opening process. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.

Conducts site initiation visits (SIV) and close-out visits.

• Prioritizes and manages own workload, and reports progress regularly to assistant director and team manager(s) as needed or requested. Creates and provides solutions to problems, reviewing processes and suggesting improvements. Escalates problems and issues, as needed.

• Oversees maintenance of CISO electronic regulatory files, clinical trial management systems, and binders with information pertinent to studying milestone progress, including but not limited to: IRB databases, internal and external spreadsheets, and study electronic systems. Reviews documentation to support regulatory filings. Prepares annual progress reports for IRB renewal of ongoing studies.

• Liaises with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws. As requested and/or required by sponsors, participates in monitoring visits.

• Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes, and ensures appropriate interpretation and application to new and existing studies and trials. Maintains compliance with good clinical practice (GCP) guidelines, patient confidentiality (HIPAA), and any other applicable laws.

• Participates in KSOM centralized activities to support and promote research regulatory requirements. Participates in CISO educational efforts, helping ensure highest quality research and protection of human subjects. Completes and submits external and reportable adverse event reports according to CISO and sponsor specific requirements. Approves amendments to protocols and trial forms and documentation, as needed.

• Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.

Preferred Qualifications:

Preferred Education:Bachelor’s Degree

Preferred Experience:5 years

Supervises:No

Preferred Field of Expertise:Collaborative Institutional Training Initiative (CITI) certification. Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies

and trials. Advanced knowledge of regulations governing human research. Familiarity with intellectual property rights, inventions, patents and technologies. Exemplary communication and interpersonal skills, with the ability to present the business side of technical topics to non-technical audiences, and persuasively and effectively interact with relationships with various stakeholders and diverse individuals and groups.

Special Instruction to Applicants:

Applicant Attachments (Required):Résumé & Cover Letter

The annual base salary range for this position is $94,189.07 - $106,520.04. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

The University of Southern California strongly values diversity and is committed to equal opportunity in employment. Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.

Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years in clinical research compliance, regulatory research and/or operations in the academic or private sector. Minimum Skills: 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. Participates in process management activities. Ability to provide both detailed information as well as summaries to management-level individuals and groups, with experience presenting ideas and solutions in non-technical, business-friendly terms. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype). Preferred Education: Bachelor's degree

REQ20152182 Posted Date: 08/28/2024