Senior IRB Manager

Senior IRB Manager

VENESCO, LLC - 3.3

San Diego, CA Job Details Full-time $47.15 - $56.78 an hour 19 hours ago Qualifications EHS Records management Data management Staff training Meeting facilitation Full Job Description Company Overview Venesco, LLC is an Equal Opportunity employer-M/F/Veteran/Disability. We are dedicated to fostering a diverse and inclusive workplace, ensuring all qualified applicants receive fair consideration for employment regardless of race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, or protected veteran status. Job Summary We are seeking a highly motivated and experienced Senior IRB (Institutional Review Board) Manager to lead and oversee our human research ethics review processes. In this pivotal role, you will ensure that all clinical research activities comply with regulatory standards and ethical guidelines. Your leadership will help maintain the integrity of our research programs while supporting the safety and rights of study participants. Responsibilities Manage and coordinate the review of research protocols to ensure compliance with FDA regulations, ICH GCP (International Conference on Harmonisation Good Clinical Practice), and other applicable standards Lead IRB meetings, prepare agendas, and facilitate discussions to reach informed approval decisions Oversee the preparation and submission of IRB documentation, including amendments, continuing reviews, and adverse event reports Ensure all research activities adhere to laboratory procedures, CGMP (Current Good Manufacturing Practice), GLP (Good Laboratory Practice), and OSHA (Occupational Safety and Health Administration) standards Collaborate with clinical research teams to develop protocols that meet regulatory requirements and ethical standards Maintain comprehensive records of IRB activities, decisions, and correspondence for audit readiness Provide training and guidance on compliance management, data security policies, and research ethics to staff members Experience Proven experience managing IRB processes within a clinical or scientific research environment Strong knowledge of FDA regulations, ICH GCP guidelines, GLP practices, and laboratory procedures Familiarity with clinical trials conduct from protocol development through data management and reporting Demonstrated ability to lead compliance initiatives related to EHS (Environmental Health & Safety) standards and information security protocols Certification in ICH GCP or equivalent is highly preferred; valid issuer for CA (California) is a plus Experience working with contracts related to research projects and understanding of research compliance management Background in scientific research or laboratory settings with exposure to clinical research environments Join us in advancing groundbreaking research while ensuring the highest standards of safety and ethics! We are committed to supporting your professional growth as you lead our efforts in ethical oversight and regulatory compliance.

Pay:

$47.15 - $56.78 per hour

Work Location:

In person