Clinical Research Regulatory Specialist

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:

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 for the Clinical Investigations Support Office.

Provides regulatory affairs support, coordinating or performing a wide variety of administrative and

data management activities for CISO 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.

JOB ACCOUNTABILITIES:

• 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 for

the Clinical Investigations Support Office. 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.

• Provides regulatory affairs support, coordinating or performing a wide variety of

administrative and data management activities for CISO functions and research

project goals. Manages and maintains CISO electronic regulatory files, including

staff resumes, licenses, training certificates, equipment receipts, investigation logs,

etc. Reviews documentation as needed to support regulatory filings, and maintains

research files and documentation required by regulations.

• Works with senior team members to support and facilitate clinical research. Helps

prepare and conduct high-quality compliance reviews, including close-out and

reporting. Interacting with research investigators and staff throughout the process,

from helping activate study and research trials to escalating problems and issues,

as needed. Provides support and clinical-specific training to staff, maintaining and

improving quality assurance training and development programs as needed.

• Updates all databases, and regulatory binders with information pertinent to studying

milestone progress, including but not limited to: clinical trial management systems,

IRB databases, internal and external spreadsheets, and study electronic systems.

• Ensures compliance with all applicable local, state, and federal regulations,

statutes, and laws, and with agencies including the IRB and Federal Drug

Administration (FDA). Maintains compliance with Good Clinical Practice (GCP)

guidelines, patient confidentiality (HIPAA) and any other applicable laws.

• Maintains communication, attends meetings, and answers questions from all

involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies

(including monitors), principal investigators and colleagues. Works with clinical trial

coordinators, research staff and investigators to further communications, helping

remove obstacles impeding trial progress.

• Participates in KSOM centralized activities to support and promote research

regulatory requirements. Coordinates with and assists other CISO staff and

departments with educational efforts, helping ensure highest quality research and

protection of human subjects. Identifies compliance training and educational needs,

coordinates the reporting of serious adverse events and protocol deviations, and

proposes, completes, and submits 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: Three years

Supervises: No

Preferred Field of Expertise: Three years' experience 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.

Special Instructions to Applicants:

Applicant Attachments (Required): Resume & Cover Letter

The annual base salary range for this position is $71,483.04 - $96,816.00. 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
Addtional 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 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).
Preferred Education: Bachelor's degree
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.