Regulatory Coordinator II (Remote)

1. About Our Client:This organization operates within the clinical research sector, focusing on managing regulatory processes for studies and clinical trials. It addresses the challenge of maintaining compliance with various regulatory bodies and institutional policies to ensure research integrity and adherence to federal and local standards. 2. About the Opportunity:The Regulatory Coordinator II plays a critical role in preparing and submitting required protocols and documents to regulatory bodies, maintaining compliance throughout the pre-award and post-award phases of clinical research. This position ensures that all regulatory requirements for studies and clinical trials are met and up-to-date, contributing to the smooth operation and legal compliance of research activities. 3. Responsibilities:Prepare and submit protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS, Cedars-Sinai IRB, External IRB, IACUC, and other relevant research committees.Submit continuations and amendments to maintain regulatory compliance.Respond to questions from IRB or IACUC regarding regulatory aspects of studies.Complete forms and generate reports as required by regulatory standards and institutional policies.Establish and maintain research files and documentation related to regulatory requirements.Represent the research department during meetings with pharmaceutical monitors.Collaborate with clinical trial coordinators, research staff, and investigators to ensure regulatory documents are current.Attend research team meetings and provide updates on regulatory submissions and amendments.Participate in training programs and provide education to personnel.Plan and coordinate strategies to improve regulatory procedures, including drafting standard operating procedures and job aids.Identify quality and performance improvement opportunities and assist in developing action plans.Ensure compliance with federal and local agencies, including FDA and Institutional Review Boards.Maintain research practices following Good Clinical Practice guidelines.Uphold patient confidentiality in accordance with HIPAA and applicable laws. 4. Requirements:Experience preparing and submitting protocols and regulatory documents to multiple regulatory bodies.Ability to respond to regulatory inquiries and maintain compliance documentation.Knowledge of federal and local regulatory requirements, including FDA and IRB standards.Familiarity with Good Clinical Practice guidelines.Strong organizational and communication skills. 5. Pay Range and Compensation Package:The pay range and compensation package for this role will be determined based on the candidate’s experience, skills, and other relevant factors. Equal Opportunity Statement: Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin. Note:RemoteHunter is a recruitment partner of this role. Please note that all employment decisions, including candidate assessment, interviews, hiring, compensation, and employment terms, are made exclusively by the hiring employer.