Kaiser Permanente CT Regulatory Specialist I in Vallejo, California
The Clinical Trial Regulatory Specialist I (CTRS-I) is a novice level position which, under the direction of the KPNC Clinical Trials Compliance Director or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Northern California (KPNC) PI and research sites conducting multiple FDA-regulated or other clinical trials. The CTRS-I position provides operational support for regulatory compliance. The CTRS-I will work with an assigned mentor on a regular basis and in consultation with the PI. This position is also responsible for assisting in protecting the health, safety, and 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 (Kaiser Permanente Code of Conduct).
W/ guidance from PI & KPNC Clinical Trials Compliance Director, assist w/ ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications.
Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures.
Assist w/ the preparation for internal & external inspections, audits & monitor visits.
Assist in assuring that all site documents, including SOPs & study regulatory files, are maintained in audit-ready condition.
Study Implementation: W/ direction from the PI, prepare the following IRB documents: New protocol applications; KP consent form draft; Protocol modification forms; 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: Current & obsolete versions of protocol & consent forms; FDA form 1572 and/or 1571; Protocol violations/deviations; Serious adverse events; Current & obsolete Investigation Drug Brochures; Documentation of IRB submissions & related correspondence, reports, & letters; Current laboratory certifications & normal reference ranges; Research staff CVs & licenses, training materials, & certifications; 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 KPNC 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.
Assist the PI w/ maintaining all study-related legal/financial documents in a confidential administrative file, if requested.
Coordinate w/ the PI regarding maintenance of regulatory IRB & other documentation & procedures.
Assist w/ 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).
Assist the PI & research personnel in the resolution of data queries, if applicable.
Assist in study closure activities including scheduling of monitor close-out visit, preparation & collection of close-out documentation, & preparation of study files for distribution to long-term storage.
Maintain long-term storage records & keep PI & Sponsor informed of any changes in the status of study records
This job description is not all encompassing.
- Minimum two (2) years of general work experience required.
Licenses, Certifications, Registrations
Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.
Must be proficient in word-processing, spreadsheet, and database software.
Skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).
Demonstrate excellent written, verbal, and interpersonal communication skills.
Ability to read and comprehend complex study documents and summarize key components in a succinct manner.
Basic knowledge of medical terminology.
Attention to detail and accuracy.
Ability to manage multiple tasks with strict timelines.
Demonstrate prioritization and organizational skills.
Problem solving skills Ability to be flexible and dependable.
Ability to work effectively on cross-functional teams.
Present professional manner and appearance.
Basic knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.
Basic knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.
Basic knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedure.
Must be able to work in a Labor/Management Partnership environment.
Health care and/or research regulatory experience preferred.
TITLE: CT Regulatory Specialist I
LOCATION: Vallejo, California
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.