Regulatory Audit Coordinator

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 regarding regulatory document collection and site status changes for fully industry funded COG trials.

Miscellaneous

• Develop and maintain SOPs, templates and guidance documents for work processes.
• Travel to COG Group Meetings and any other business-related meetings.
• Perform other duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

Minimum Qualifications

• Two (2) years experience as a Clinical Regulatory Coordinator, Clinical Trial Auditor, Clinical Trail Monitor or other relevant human clinical trials research experience that includes direct knowledge of FDA Regulations and ICH Guidelines.
• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or related field, or substitute with four additional years of related experience.

Other Qualifications

• Ability to analyze clinical trial protocols, consent forms and protocol deviation submissions to identify compliance issues.
• Experience with oncology clinical trials.
• Must have knowledge of clinical trial related FDA regulations, ICH-GCP Guidelines.
• High attention to detail and accuracy in document review, data entry, and query resolution.
• Strong organizational skills with the ability to manage multiple regulatory submissions and deadlines simultaneously.
• Ability to work on a team and independently.
• Excellent verbal and written communication skills.
• Ability to maintain confidentiality of sensitive study and participant information.
• Microsoft Office suite and applicable software program(s) proficiency.
• Ability to travel to COG Group Meetings and any other business-related meetings.

Preferred Qualifications

• Demonstrated knowledge of regulatory processes and applicable regulations preferred.
• SOCRA membership preferred.

Fair Labor Standard Act (FLSA) Status

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.