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 regu... more details
Description:
Job Summary:
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 positions scope of practice as outlined in the Major Responsibilities below.
Essential Responsibilities:
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 KPNC IRB 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.
Assist with the preparation for internal and external inspections, audits and monitor visits.
Assist in assuring that all site documents, including SOPs and study regulatory files, are maintained in audit-ready condition.
Study Implementation:
With 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; and e. 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; 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.
Assist the PI with maintaining all study-related legal/financial documents in a confidential administrative file, if requested.
Coordinate with the PI regarding maintenance of regulatory IRB and other documentation and procedures.
Assist with 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).
Assist the PI and research personnel in the resolution of data queries, if applicable.
Assist in study closure activities including scheduling of 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:
Assist the PI in prompt implementation of IRB/Sponsor directives to protect the health, safety, and welfare of research participants.
Maintain communication with internal/external parties and research team regarding regulatory document matters.
Education and Training:
Participate in training, education and development activities to improve own knowledge and performance to sustain and enhance professional development.
Work with an assigned mentor on a regular basis for training and resource questions. Attend Sponsor site initiation meetings.
Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested.
Quality Improvement:
With direction, 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 reevaluate 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.
Basic Qualifications:
Experience
Minimum two (2) years of general work experience required.
Education
Associates degree.
License, Certification, Registration
N/A
Additional Requirements:
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.
Preferred Qualifications:
Health care and/or research regulatory experience preferred.
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