Regulatory Specialist II, Clinical Trials
Company: Kaiser Permanente Zion Medical Center
Posted on: June 6, 2021
* 1 of 3 Openings *
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
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
Perform duties such as filing, photocopying, faxing, & distributing
W/ direction from PI, assist in preparation of annual, interim &
final KPNC IRB reports.
Maintain current licensure documentation including MD/RN licenses &
Maintain training & education documentation for research
Obtain regulatory certifications including KP laboratory state
licenses, current laboratory certifications & normal reference
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 &
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, &
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
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
- 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
- Minimum two (2) years of
work experience in an ambulatory and/or acute health care setting
- Bachelor's degree preferred.
- CIP, CIM, ACRP, SOCRA or RAC certification preferred.
Keywords: Kaiser Permanente Zion Medical Center, Oakland , Regulatory Specialist II, Clinical Trials, Other , Oakland, California
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