In order to be successful in this role, you will have direct regulatory
The Clinical Trial Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency which, under the direction of the KPNC clinical trials administrative management or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Northern California (KPNC) PI and research site(s) conducting multiple FDA-regulated or other clinical trials. The CTRS-II has demonstrated proficiency in providing operational support for Sponsor and IRB regulatory compliance. The CTRS-II works independently and assumes increased responsibilities. 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/ 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; New protocol applications; KP consent form draft; Protocol modification forms; Adverse Event/Serious Adverse Event summary for annual report; & 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.
- W/ direction from PI, communicate & coordinate w/ the Sponsor regarding study document regulatory file 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 project management experience in clinical trials research or human subjects protections required.
Licenses, Certifications, Registrations
- Proficient in electronic health systems and databases used in research environment, word-processing and spreadsheets.
- Proficient in medical terminology.
- Demonstrates written, verbal, and interpersonal communication skills.
- Attentive to detail and accuracy.
- Effectively manages multiple tasks with strict timelines.
- Demonstrates prioritization and organizational skills.
- Problem solving skills.
- Flexible and dependable.
- Works effectively on cross functional teams.
- Presents a professional manner and appearance.
- 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 able to work in a Labor/Management Partnership environment.
- Minimum two (2) years of work experience in an ambulatory and/or acute health care setting preferred.
- Bachelor's degree preferred.
- CIP, CIM, ACRP, SOCRA or RAC certification preferred.