St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Regulatory Coordinator I is responsible is to review, prepare, and submit clinical trial protocols to the IRB ensuring compliance with all local, state, ICH/GCP Guidelines, and federal regulations and to provide administrative support to the regulatory team within the SLUHN Clinical Trials Office. JOB DUTIES AND RESPONSIBILITIES: Demonstrates basic knowledge and practice of ICH/GP guidelines, FDA regulations and guidelines, HIPPA Regulations and Confidentiality Policy, and IRB policies related to clinical research. Apply knowledge and skills to independently process IND Safety reports via Excel for all industry, Institutional, and NCTN (cooperative group) studies in an expeditious manner. Track IRB submissions, approvals and expiration dates for all protocols, including initial, annual and amendment submissions to ensure timely turnaround times. Ensure that submissions are accurate, properly formatted, complete, and in compliance with regulations and IRB policies and procedures. Collaborates with the Regulatory team and other clinical trials staff to develop and maintain procedures for management of all regulatory aspects of the clinical trials. Acquire the appropriate signatures for regulatory forms, and develop tracking tools for this process. Prepare, maintain, and file all essential regulatory documentation required by sponsor or CRO (1572s, Financial Disclosure Forms, Delegation Logs, CVs and Medical Licenses, FCOI forms, SAEs and UAPs, training logs, etc.) within the study and regulatory binders. Collect, maintain, and file all institutional clinical trials training requirements and tracking logs (NIH COI tutorial, CITI GCP, SLUHN COI disclosure statement, CVs, and Medical Licenses) Collect, maintain, and file all institutional laboratory documents and tracking logs for Network (Lab Normal Reference Ranges, CAP, CLIA, Lab Permits, and Lab Director CV and Medical License) Maintain NCI Investigator registration on a yearly basis as required by the NCI for NCTN studies. PHYSICAL AND SENSORY REQUIREMENTS: Requires sitting for up to seven hours per day, 5 hours at a time. Standing for up to 4 hour per day, 3 hours at a time. Requires frequent fingering, handling and twisting and turning. Frequently requires lifting, carrying and pushing and pulling objects weighing up to 20 pounds. Frequently requires reaching above shoulder level and bending down. Must have the ability to hear as it relates to normal conversation, seeing as it relates to general vision. EDUCATION: Associate degree required; will accept High School degree with 1-2 years regulatory or administrative assistant/office management experience. Familiar with medical terminology preferred. TRAINING AND EXPERIENCE: Required: Knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions. Must possess strong organizational skills and strong attention to detail. Must be able to multi-task efficiently. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!! St. Luke's University Health Network is an Equal Opportunity Employer.
