Regulatory Audit Coordinator

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🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $70.296 - $101.911 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

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COG Research

SiteLinkedInTodas as Vagas

2 - 10 funcionários

Fundada em 2000

📣 Marketing

💼 Consultoria

Marketing • Consulting

A COG Research é uma consultoria de pesquisa de mercado e insights com atuação no Reino Unido e na Espanha, focada em “buscar a verdade” por meio de metodologias avançadas. A empresa oferece testes implícitos/IRT, análise de vieses inconscientes, mensuração da eficácia de comunicações, avaliação de canais e contextos de mídia, pesquisa qualitativa e etnográfica inovadora e estudos quantitativos de alto engajamento para orientar o território e a estratégia de marca. A COG Research se posiciona como uma empresa especializada em consultoria estratégica orientada por pesquisas para equipes de comunicação e branding.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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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