CT Regulatory Specialist II

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 positions scope of practice as outlined in the Major Responsibilities below.

Compliance

• Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct).


• With guidance from PI and KPNC Clinical Trials Compliance Director, assist with ensuring compliance with  Standard Operating Procedures (SOP) and document applications.


•  Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures.


• Assure all site documents including SOPs and administrative files are maintained in audit-ready condition.


• Assist with internal and external audits and quality assurance activities including monitoring visits, audits and  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; and IND Safety Report Summary sheet for annual report.


• Assist the PI and other designated research staff in the preparation, submission, and maintenance of the following study-related regulatory documents: Current and obsolete versions of protocol and consent forms; FDA form 1572 and/or 1571; Protocol violations/deviations; Serious adverse events; Current and obsolete Investigation Drug Brochures; Documentation of IRB submissions and related correspondence, reports, and letters; Current laboratory certifications and normal reference ranges; Research staff CVs and licenses, training materials, and certifications; and Test article accountability forms, signature logs, etc.


• Perform duties such as filing, photocopying, faxing, and distributing study-related documents.


• With direction from PI, assist in preparation of annual, interim and final KPNC IRB reports.


• Maintain current licensure documentation including MD/RN licenses and CVs.


• Maintain training and education documentation for research personnel.


• Obtain regulatory certifications including KP laboratory state licenses, current laboratory certifications and normal  reference ranges.


• With direction from PI, communicate and coordinate with the Sponsor regarding study document regulatory file  activities and functions, including scheduling and conducting Sponsor-initiated monitor visits and following-up  on outstanding items.


• Coordinate with the PI and internal/external parties regarding the collection and maintenance of regulatory IRB  and other documentation and 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, and IRB history).


• Maintain all study-related legal and financial documents in separate confidential regulatory file in a timely manner,  as requested.


• Assist in study closure activities including scheduling monitor close-out visit, preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.


• Maintain long-term storage records and keep PI and Sponsor informed of any changes in the status of study records.

Leadership and Communication

• Act as liaison with internal/external parties and research team regarding regulatory document activities.


• With direction, facilitate communication of regulatory documents and requirements for multiple FDA-regulated or other clinical trials.

Education and Training

• Participate in training, education and development activities to improve own knowledge and performance to  sustain and enhance professional development.


• Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested.


• Assist with training and orientation of new hires.

Quality Improvement

• Perform routine quality control activities and assist with quality improvement initiatives.

Systems and Infrastructure

• Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical  research interactions and participant information, and responsible use of operational research databases in  compliance with KP policies.


• Adhere to departmental policies and procedures to support high-quality implementation and conduct of clinical  trials, and assure maintenance of research documentation in compliance with the protocols and KP policies and  procedures.


•  Maintain systems and resources to effectively communicate with and obtain required IRB documentation.


• Participate with PI(s) and clinical trials administrative management to identify and prioritize the development of  clinical trials systems and infrastructure to maintain research quality and compliance of regulatory files at clinical  trial sites.

Staff Supervision

• No supervisory responsibilities.

General

• Perform job functions according to the factors listed below under Job Criteria.


• Other duties as assigned by appropriate management.


• Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to re-evaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees.