Regulatory Audit Coordinator

COG Research Foundation, LLC (Research Foundation) is a California 501(c)(3) entity founded in 2024 to serve as a fiscal sponsor to support research programs by providing legal, fiduciary, and administrative oversight for the program. The Research Foundation serves as the fiscal sponsor for the Children’s Oncology Group (COG). COG, a member of the National Cancer Institute (NCI) National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 13,500 experts in childhood cancer at more than 220 leading children’s hospitals, universities, and cancer centers across the United States, Canada, Australia, New Zealand, and Saudi Arabia to conduct more than 50 active clinical trials, with approximately 9,500 participants registered each year in the fight against childhood cancer. Position Summary All staff are employed through the Research Foundation. This role will be in service to COG. The primary responsibility for the Regulatory Audit Coordinator is to conduct the regulatory component of COG audits for all COG institutions as defined in the NCI’s Clinical Trials Monitoring Branch (CTMB) guidelines. This requires diligent review of IRB submission and review of institutional informed consent documents to ensure compliance with the COG template and appropriate policies. Additionally, the Regulatory Audit Coordinator is responsible for receipt and review of submitted regulatory documents for compliance with federal regulations and COG policies by reviewing regulatory document submissions for fully industry funded COG studies, as well as review of protocol deviation forms submitted in Medidata Rave and early closure forms from sites. The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required. Employee must reside within the United States. Full salary range for this position: $70,296 to $101,911 per year. The typical hiring range for this position is from $70,296 (minimum) to $86,104 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability. Essential Duties and Responsibilities COG Audit Program Conduct reviews of Institutional Review Board (IRB) submissions and Informed Consent Content (ICC) for the regulatory component of COG audits. Record audit findings on regulatory audit worksheets and translate findings into draft audit reports for distribution to sites and on-site auditors. Distribute finalized audit findings to the site and on-site auditors in accordance with applicable SOPs, ensuring compliance with established timelines. Identify and clarify any discrepancies, ambiguities or unsupported findings with the Senior Director of Quality Assurance & Audit prior to report finalization. Respond to complex questions from institutions or physician auditors regarding regulatory findings. Review and evaluate corrections from sites and update regulatory summaries to reflect accurate findings. Conduct second and for cause regulatory audits, as applicable. Develop and maintain regulatory audit summary and correction templates for use during regulatory audits. Prepare presentations, organize slides and present to site Clinical Research Associates (CRAs) at the Quality Assurance (QA) and Audit education sessions at COG Group Meetings and virtually. Participate in COG audit discussions with the NCI CIRB and other regulatory bodies. Respond to site questions regarding the regulatory component of the audit. Protocol Deviations Oversee the intake and review of protocol deviation forms in accordance with protocol requirements and internal SOPs, downloading and routing forms for QA leadership review and entering queries in the as necessary to ensure deviations are accurately documented, and resolved prior to closure. Work with sites on obtaining necessary information regarding deviations. Request Corrective and Preventive Actions (CAPAs) from sites consistent with COG policy. Complete the Lead Protocol Organization (LPO) fields on protocol deviation forms in Rave. Early Closure Forms Evaluate early closure requests, complete LPO validation fields, and serve as the primary regulatory contact for site inquiries regarding early closure requests. Work with NCI Cancer Trials Support Unit (CTSU), COG membership, COG leadership and sites on site closures or NCI code changes to ensure that study subjects are transferred per COG policies and established SOPs and early closure forms adequately document the required details. Regulatory Document Collection Provide input on site-facing communications regarding required regulatory documents, consistent with COG policy and federal regulations. Review and evaluate submitted regulatory documents from sites activating fully industry funded COG trials to ensure compliance with regulatory requirements outlined in the study start up documents. Work with sites to obtain any missing documentation. Coordinate site registration status changes, ensuring alignment with protocol milestones and federal compliance metrics. Respond to questions reg