Regulatory Services Manager – National Center for Clinical Trials

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🕒 Outubro 26

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $44 - $66 / hora

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Advocate Aurora Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

⚕️ Seguro de Saúde

💰 $10.200.000 Grant em 2019-08

Healthcare • Healthcare Insurance

A Advocate Aurora Health é uma organização de saúde líder que atua em várias regiões, incluindo Central Chicagoland, Central Wisconsin, Greater Milwaukee, entre outras. Com uma ampla gama de áreas de carreira como clínicos de prática avançada, saúde comportamental, enfermagem e mais, a Advocate Aurora Health está comprometida em ajudar as pessoas a viver bem. A organização oferece inúmeros benefícios e oportunidades de avanço na carreira, promovendo um ambiente onde os indivíduos podem prosperar e inovar no setor de saúde. A Advocate Aurora Health prioriza a segurança de seus candidatos e mantém um robusto processo de recrutamento para proteger informações sensíveis.

Descrição

• Provide overall administrative direction and coordination of Regulatory Services for NCCT clinical research • Ensure compliance with institutional, IRB, federal, and other applicable regulatory requirements across clinical trials • Supervise and guide staff on IRB submissions, HIPAA compliance, and regulatory communications • Develop, implement, and enforce policies, procedures, and tools supporting compliant research operations • Lead hiring, training, performance management, coaching, and professional development for regulatory staff • Oversee IRB submissions and approvals, regulatory documentation, and study closures • Ensure compliance with GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and SOPs • Manage audits and inspections, including responses to findings and CAPA plans • Oversee regulatory projects and workflows, timelines, deliverables, risks, and resources • Communicate regulatory status and compliance issues to investigators, study teams, and leadership • Monitor regulatory changes and lead related process or policy updates • Support protocol development, study start-up, and close-out activities • Maintain relationships with stakeholders, sponsors, IRB, and regulatory agencies • Prepare regulatory metrics, reports, and compliance analyses • Participate in research compliance and regulatory affairs meetings and committees • Manage special regulatory projects and perform related duties

🎯 Requisitos

• Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or an equivalent combination of education and experience • Experience in a medical/research environment preferred • Excellent verbal and written communication skills • Knowledge of scientific and statistical principles • Ability to travel to affiliate sites, clinical sites, and national meetings • Familiarity with institutional and governmental regulations and guidelines related to clinical research • Knowledge of Good Clinical Practices

🏖️ Benefícios

• Comprehensive Total Rewards benefits and well-being programs • Competitive compensation • Generous retirement offerings • Career development programs • Premium pay such as shift and on-call pay, based on eligibility • Incentive pay for select positions • Opportunity for annual performance-based increases • Paid Time Off programs • Medical, dental, vision, life, and short- and long-term disability benefits • Flexible Spending Accounts for eligible health care and dependent care expenses • Adoption assistance • Paid parental leave • Defined contribution retirement plans with employer match • Financial wellness programs • Educational Assistance Program

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