IRB Regulatory Specialist, Clinical Trials Research
Kaiser Permanente’s Division of Research is currently seeking a Clinical Trials Regulatory Specialist II (CTRS-II). The 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.
Some Essential Functions Include:
• Compliance: Support & comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). • With guidance from PI & KPNC Clinical Trials Compliance Director, assist with ensuring compliance with 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 with 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 (e.g. consent forms, FDA forms, IRB submissions, Research staff CVs/licenses, etc.)
A minimum of three (3) years of project management experience in clinical trials research or human subjects’ protections required.
An Associate's degree.
Proficiency in electronic health systems and databases used in research environment along with word-processing and spreadsheets.
Ability to demonstrate excellent written, verbal, and interpersonal communication skills.
Be attentive to detail and accuracy with the ability to effectively manages multiple tasks with strict timelines.
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.
Highly Preferred Qualifications:
A minimum of two (2) years of work experience in an ambulatory and/or acute health care setting preferred.
A Bachelor's degree or Master’s degree.
CIP, CIM, ACRP, SOCRA or RAC certification.
Additional Salary Information: We offer a comprehensive compensation package, including employer-paid medical, dental and coverage for eligible dependents. Competitive wages, generous paid time-off and a comprehensive retirement plan are just part of the exceptional benefits offered to Kaiser Permanente employees. For immediate consideration, interested candidates should submit their letter of interest and resume/CV by visiting www.kp.org/careers for complete qualifications and job submission details, referencing position number 897815. For more information please contact email@example.com
Internal Number: 897815
About Kaiser Permanente, Division of Research
More than 50 years ago, our founder Morris F. Collen, MD, recognized the potential of combining the power of information technology with clinical care and sophisticated data analytics. Since its inception in 1961, Kaiser Permanente’s Division of Research has become internationally respected for research that transforms health by discovering the key drivers of health and disease, and identifying effective and efficient ways to deliver health care.
The Division is one of the nation's largest research facilities outside of a government or university setting. We are the primary professional home of more than 50 research scientists and 500 staff members who lead studies in epidemiology, health services, and clinical trials. Our studies cover a wide range of clinical topics, including cardiovascular disease, cancer, diabetes, substance abuse, mental health, maternal and child health, women’s health. Our research addresses broad issues, including the role of genes and the environment in health, the influence of behavior on disease prevention and chronic illness management, drug safety, health care policy, health services delivery, and disparities. We have almost 400 ongoing projects and ...contribute more than 300 scientific papers to peer-reviewed journals each year.
Kaiser Permanente's Division of Research’s work is funded primarily by federal agencies, such as the National Institutes of Health, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. The Permanente Medical Group and Kaiser Foundation Health Plan's Community Benefit Program are our major internal sponsors.
Partnerships and collaboration are a hallmark of our work. We provide crucial support to physician researchers from The Permanente Medical Group, and we collaborate with researchers from other regions of Kaiser Permanente, other organizations in the Health Care Systems Research Network, federal and state agencies, and academic institutions across the country. Of particular note are our rich collaborative relationships with academic centers in the Bay Area, including the University of California, San Francisco; Stanford University School of Medicine; and the University of California, Berkeley, School of Public Health.