Innovation in Practice
Operating one of the industry’s largest and most respected research programs, Kaiser Permanente employs nearly 1,800 research experts at 9 specialized centers across the country. With a research budget of $221 million and more than 2,500 studies and clinical trials underway at any given time, this is a place where you can have a profound impact on the future of health.
Clinical Trial Regulatory Specialist IILocation: Oakland, CA Additional Locations:
Job Number: 776251 Date posted: 03/20/2019
The Clinical Trial
Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency
which, under the direction of the Kaiser Permanente Northern California (KPNC) clinical
trials administrative management or designee and Principal Investigator (PI),
provides regulatory document support to the KPNC Principal Investigator 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.
guidance from PI and KPNC Clinical Trials Compliance Director, assists with
ensuring compliance to Standard Operating Procedures (SOP) and document
- Adheres to Guideline for Good Clinical Practice (GCP), federal, state, and
local regulations, and KP policies and procedures.
- Assures all site documents including SOPs and administrative files are
maintained in audit-ready condition.
- Assists with internal / external audits and quality assurance activities
including monitoring visits, audits and inspections.
- Support the cost effective financial aspects of the clinical trial.
Prepares 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.
- Assists 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.
- Performs duties such as filing, photocopying, faxing, and distributing
- Under direction from PI, assists in preparation of annual, interim and final
KPNC IRB reports.
- Maintains current licensure documentation including MD/RN licenses and CVs.
- Maintains training and education documentation for research personnel.
- Obtains regulatory certifications including KP laboratory state licenses, current
laboratory certifications and normal reference ranges.
- Under direction from PI, communicates and coordinates with the Sponsor
regarding study document regulatory file activities and functions, including
scheduling and conducting Sponsor-initiated monitor visits and following-up on
- Coordinates with the PI and internal/external parties regarding the
collection and maintenance of regulatory IRB and other documentation and
- Performs 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).
- Maintains all study-related legal and financial documents in separate
confidential regulatory file in a timely manner, as requested.
- 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.
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 and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
About Research & Development Careers
Careers in Research & Development
Recognized worldwide for their scientific expertise, our researchers collect data on topics including cardiovascular disease, diabetes, mental health, and drug safety — just to name a few.
In addition to studies centered at these facilities, our physicians and researchers conduct clinical trials of new drugs, medical devices, and other therapies through several organized centers and independently at single sites. Put together, Kaiser Permanente's research centers and scientists comprise one of the largest and most comprehensive nonacademic research programs in the United States.
As a member of this team, you'll engage in meaningful work that has the power to affect outcomes and improve global health. Focused on areas like public-sector health services, epidemiology, and behavioral and clinical research, the work you do will ultimately allow us to improve the cost effectiveness and quality of the care we deliver — all while saving lives.
See What People are Saying About Working at KP
Mar 26, 2019
"The best job I have ever had!"
- Positive Outlook
- Approves of CEO
I have been working at Kaiser Permanente full-time for more than a year
Real focus on creating higher quality, more affordable healthcare. Talented coworkers and great mentors. Fabulous benefits.Full Review
Come introduce yourself to a member of the Kaiser Permanente team at an upcoming career or professional event. We look forward to meeting you in person.
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