Regulatory Audit Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Carry out regulatory assessments of Institutional Review Board (IRB) submissions and Informed Consent Content (ICC) for COG audits.

• Document audit results on regulatory audit worksheets and convert findings into initial audit reports.

• Share finalized audit results with sites and on-site auditors, adhering to SOPs and schedules.

• Resolve discrepancies, ambiguities, or unsupported findings with the Senior Director of Quality Assurance & Audit.

• Address intricate inquiries from institutions, physician auditors, and sites concerning regulatory findings.

• Review site amendments and revise regulatory summaries as needed.

• Execute second and for-cause regulatory audits.

• Create and sustain regulatory audit summary and correction templates.

• Prepare and deliver QA and Audit training sessions to site Clinical Research Associates (CRAs).

• Engage in audit discussions with the NCI CIRB and other regulatory entities.

• Supervise the intake and evaluation of protocol deviation forms in Medidata Rave, direct forms for QA leadership review, and enter queries when necessary.

• Gather information from sites regarding deviations and request Corrective and Preventive Actions (CAPAs).

• Fill out Lead Protocol Organization (LPO) fields on protocol deviation forms in Rave.

• Assess early closure requests, complete LPO validation fields, and act as the primary regulatory contact for site inquiries.

• Collaborate with NCI CTSU, COG membership, leadership, and sites on site closures or NCI code modifications.

• Contribute to site communications regarding necessary regulatory documents.

• Review regulatory documents from sites launching fully industry-funded COG trials.

• Acquire missing documentation and coordinate site registration status updates.

• Develop and maintain SOPs, templates, and guidance documents.

• Travel to COG Group Meetings and other professional gatherings.

• Perform additional duties as assigned.

⛳️ Requirements

• Minimum of two (2) years of experience as a Clinical Regulatory Coordinator, Clinical Trial Auditor, Clinical Trial Monitor, or other relevant experience in human clinical trials, including direct knowledge of FDA Regulations and ICH Guidelines.

• Bachelor's degree in biology, chemistry, biochemistry, physiology, nursing, or a related field, or four additional years of relevant experience as a substitute.

• Capability to analyze clinical trial protocols, consent forms, and protocol deviation submissions to identify compliance issues.

• Experience with oncology clinical trials is preferred.

• Understanding of clinical trial-related FDA regulations and ICH-GCP Guidelines.

• Exceptional attention to detail and accuracy in document review, data entry, and query resolution.

• Strong organizational abilities and capacity to manage multiple regulatory submissions and deadlines concurrently.

• Ability to work independently as well as collaboratively within a team.

• Excellent verbal and written communication capabilities.

• Commitment to maintaining the confidentiality of sensitive study and participant information.

• Proficiency in Microsoft Office suite and relevant software programs.

• Willingness to travel to COG Group Meetings and other business-related meetings.

• Successful pre-employment background check; credit check may be required where applicable and permitted.

• SOCRA membership is preferred.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• Accrued Paid Time Off (PTO).

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Cell phone stipend.

• Internet stipend.

• Wellness stipend.

• Paid holidays.

• Background check individualized assessment and fair chance hiring practices.

• Reasonable accommodations for applicants with disabilities.