Clinical Trials Regulatory Specialist II Los Angeles, CA
The Clinical Trial Regulatory Specialist II (CTRS-II) is a position w/demonstrated proficiency which, under the direction of the KPSC clinical trials administrative Mgmt or designee & Principal Investigator (PI), provides regulatory document support to the KP Southern California (KPSC) PI & research site(s) conducting multiple FDA-regulated or other clinical trials. The CTRS-II has demonstrated proficiency in providing operational support for Sponsor & IRB regulatory compliance. The CTRSII works independently & assumes increased responsibilities. This position is also responsible for assisting in protecting the health, safety, & welfare of research participants. This is a non-licensed position which must adhere to the position's scope of practice as outlined in the Major Responsibilities below.
- Compliance: Support & comply w/the Principles of Responsibility (KP Code of Conduct).
- W/guidance from PI & KPSC Clinical Trials Compliance Dir, assist w/ensuring compliance w/KPSC IRB Standard Operating Procedures (SOP) & document applications.
- Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures.
- Assure all site documents including SOPs & administrative files are maintained in audit-ready condition.
- Assist w/internal & external audits & quality assurance activities including monitoring visits, audits & inspections.
- Support the cost effective financial aspects of the clinical trial.
- Study Implementation: Prepare the following IRB documents: a. new protocol applications; b. KP consent form draft; c. Protocol modification forms; d. Adverse Event/Serious Adverse Event summary for annual report; & e. IND Safety Report Summary sheet for annual report.
- Assist the PI & other designated research staff in the preparation, submission, & maintenance of the following study-related regulatory documents: a. Current & obsolete versions of protocol & consent forms; b. FDA form 1572 &/or 1571; c. Protocol violations/deviations; d. Serious adverse events; e. Current & obsolete Investigation Drug Brochures; f. Documentation of IRB submissions & related correspondence, reports, & letters; g. Current laboratory certifications & normal reference ranges; h. Research staff CVs & licenses, training materials, & certifications; & i. Test article accountability forms, signature logs, etc.
- Perform duties such as filing, photocopying, faxing, & distributing study-related documents.
- W/direction from PI, assist in preparation of annual, interim & final KPSC IRB reports.
- Maintain current licensure documentation including MD/RN licenses & CVs.
- Maintain training & education documentation for research personnel.
- Obtain regulatory certifications including KP laboratory state licenses, current laboratory certifications & normal reference ranges.
- W/direction from PI, communicate & coordinate w/the Sponsor regarding study document regulatory file on activities & functions, including scheduling & conducting Sponsor-initiated monitor visits & following-up on outstanding items.
- Coordinate w/the PI & internal/external parties regarding the collection & maintenance of regulatory IRB & other documentation & procedures.
- Perform data entry of study activities into a database program to track pertinent study activity (i.e., study enrollment, consents, protocol violations/deviations, serious adverse event reports, & IRB history).
- Maintain all study-related legal & financial documents in separate confidential regulatory file in a timely manner, as requested.
- This job description is not all encompassing.
- Minimum three (3) years of effective project management experience in clinical trials research or human subject's protections required.
- Bachelor's degree may be substituted for one (1) year work experience.
- Associate's degree required, OR two (2) years of experience in a directly related field required.
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- Comprehensive knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.
- Comprehensive knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.
- Comprehensive knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
- Must be proficient in electronic health systems and databases used in research environment, word-processing and spreadsheets.
- Demonstrate proficiency in medical terminology.
- Demonstrate written, verbal, and interpersonal communication skills.
- Attention to detail and accuracy.
- Ability to effectively manage multiple tasks with strict timelines.
- Demonstrate prioritization and organizational skills.
- Ability to address issues with problem solving skills.
- Ability to be flexible and dependable.
- Ability to work effectively on cross-functional teams.
- Present professional manner and appearance.
- Must be able to work in a Labor/Management Partnership environment.
- RAC certification will be considered.
- CIP, CIM, ACRP or SOCRA certification preferred.
Primary Location: California,Los Angeles,4733 Sunset Annex 4733 W. Sunset Blvd.
Scheduled Hours (1-40): 40
Working Days: Mon, Tue, Wed, Thu, Fri
Job Type: Standard
Employee Status: Regular
Employee Group: Salaried, Non-Union, Exempt
Job Level: Manager with Direct Reports
Job: Research and Development
Public Department Name: Clinical Trials - Oncology
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.
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