Regulatory Audit Coordinator

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🇺🇸 United States – Remote

💵 $70.3k - $101.9k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

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COG Research

WebsiteLinkedInAll Job Openings

2 - 10 employees

Founded 2000

📣 Marketing

💼 Consulting

Marketing • Consulting

COG Research is a UK & Spain–based market research and insights consultancy that focuses on “seeking the truth” through advanced methodologies. The firm offers implicit/IRT testing, unconscious bias analysis, communications efficacy measurement, media channel and context evaluation, innovative qualitative and ethnographic research, and high‑engagement quantitative studies to inform brand territory and strategy. COG Research positions itself as a specialist provider of research-driven strategic consulting for communications and brand teams.

📋 Description

• Conduct regulatory reviews of Institutional Review Board (IRB) submissions and Informed Consent Content (ICC) for COG audits • Record audit findings on regulatory audit worksheets and translate findings into draft audit reports • Distribute finalized audit findings to sites and on-site auditors in accordance with SOPs and timelines • Clarify discrepancies, ambiguities, or unsupported findings with the Senior Director of Quality Assurance & Audit • Respond to complex questions from institutions, physician auditors, and sites regarding regulatory findings • Review site corrections and update regulatory summaries • Conduct second and for-cause regulatory audits • Develop and maintain regulatory audit summary and correction templates • Prepare and present QA and Audit education sessions to site Clinical Research Associates (CRAs) • Participate in audit discussions with the NCI CIRB and other regulatory bodies • Oversee intake and review of protocol deviation forms in Medidata Rave, route forms for QA leadership review, and enter queries as necessary • Obtain information from sites regarding deviations and request Corrective and Preventive Actions (CAPAs) • Complete Lead Protocol Organization (LPO) fields on protocol deviation forms in Rave • Evaluate early closure requests, complete LPO validation fields, and serve as the primary regulatory contact for site inquiries • Coordinate with NCI CTSU, COG membership, leadership, and sites on site closures or NCI code changes • Provide input on site communications regarding required regulatory documents • Review regulatory documents from sites activating fully industry-funded COG trials • Obtain missing documentation and coordinate site registration status changes • Develop and maintain SOPs, templates, and guidance documents • Travel to COG Group Meetings and other business-related meetings • Perform other duties as assigned

🎯 Requirements

• Two (2) years experience as a Clinical Regulatory Coordinator, Clinical Trial Auditor, Clinical Trial Monitor, or other relevant human clinical trials research experience including direct knowledge of FDA Regulations and ICH Guidelines • Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or related field, or four additional years of related experience as a substitute • Ability to analyze clinical trial protocols, consent forms, and protocol deviation submissions to identify compliance issues • Experience with oncology clinical trials • Knowledge of clinical trial-related FDA regulations and ICH-GCP Guidelines • High attention to detail and accuracy in document review, data entry, and query resolution • Strong organizational skills and ability to manage multiple regulatory submissions and deadlines simultaneously • Ability to work independently and on a team • Excellent verbal and written communication skills • Ability to maintain confidentiality of sensitive study and participant information • Proficiency with Microsoft Office suite and applicable software programs • Ability to travel to COG Group Meetings and other business-related meetings • Satisfactory pre-employment background check; credit check may be required where relevant and permitted • SOCRA membership 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 accommodation for applicants with disabilities

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