CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional), CIP (Certified IRB Professional), RAC (Regulatory Affairs Certification)
Learn more and apply online at https://www.kaiserpermanentejobs.org/job/aurora/regulatory-administrator/641/8499447
Contact the hiring manager at Josh.B.Gordon@kp.org
Provides regulatory support to the KPCO clinical trials team through collaboration with the research sponsors, clinical research staff, and clinical trials management team. Works in collaboration with the KPCO Clinical Trials Manager, Clinical Trials Business Consultant, clinical trials research team and Clinician Investigators. Coordinates, compiles and maintains all regulatory documentation for clinical trials according to IRB, FDA, sponsor policies as well as with federal and state laws regarding research conduct and documentation. Maintains knowledge of and assures departmental compliance with Good Clinical Practices (GCP) and applicable regulatory requirements. Maintains knowledge of policies and procedures and performs in accordance with the Principles of Responsibilities and applicable regulatory requirements, external laws and accreditation standards. Reports, appropriately, observed fraud or abuse.
Coordinates regulatory activities of all clinical trials being conducted at KPCO.
Manages the process for ensuring appropriate documentation of all aspects of the clinical trials regulatory process ensuring accuracy and compliance with IRB, FDA, Good Clinical Practices, and federal and state regulations.
Provides supervision and coordination of all regulatory activities, workflow and regulatory staff.
Assists Clinical Trials Manager with budgeting and billing for clinical trials processes.
Coordinates preparation and submission of IRB/RRC applications and modifications.
Develops, implements, and/or oversees orientation and education of investigators and research study staff in the regulatory process for biomedical research, in compliance with federal and local regulations.
Coordinates with IHR finance, contracts and grants on invoicing sponsors and maintains clinical trials areements. Maintains, updates and reviews all clinical trials SOPs.
Develops and maintains knowledge of good clinical practice standards.
Coordinates other research activities, e.g., federal audits, discussions with investigators and communications with research subjects.
Oversees iMEDRIS clinical trials tracking and documentation systems.
Serves as a resource to the institution, research staff and investigators regarding current and developing FDA regulations regarding the participation and protection of human research subjects. Performs other duties as assigned.
Minimum four (4) years of experience with IRB and clinical trials documentation required. Education
High School Diploma or General Education Development (GED) required. License, Certification, Registration
Experience in a regulatory environment.
Outstanding verbal and written communication skills and human relations skills.
Attention to detail and demonstrated accuracy in written documentation.
Excellent project management, time management, problem solving and customer service skills.
Ability to work independently and delegate tasks to others.
Proficiency in spreadsheets and word processing applications required.
Occasional travel required.
Knowledge of GCPs.
Ability to interpret and apply federal regulations and organizational policies and procedures related to the administration of research activities.
Strong work group, staff member, team and committee leadership and management skills.
Bachelor's degree in public administration or health care related field preferred OR four (4) years of experience in a directly related field.
Internal Number: 711699
About Kaiser Permanente
Our Clinical Trials Program started in 1998 with a small group of Kaiser Permanente employees scattered among various Colorado locations. In 2002, a formal Clinical Trials Program office was established to conduct clinical trials in Colorado.
Now, the Clinical Trials Program consists of over a dozen employees, specifically trained and certified in the conduct of clinical trials. The team works with the National Institutes of Health (NIH) and various pharmaceutical companies to conduct voluntary clinical trials with our Kaiser Permanente members.