Regulatory Services Manager – National Center for Clinical Trials

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🕒 Setembro 28

🌲 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

• Provides overall administrative direction and coordination of Regulatory Services for NCCT clinical research • Ensures compliance with institutional, IRB, federal and other applicable regulatory requirements across clinical trials • Supervises and guides staff regarding IRB submissions, HIPAA compliance and regulatory communications • Develops, implements and enforces policies, procedures and tools supporting compliant and efficient research operations • Leads hiring, training, performance management, coaching and professional development for regulatory staff • Oversees initial and continuing IRB reviews, amendments, reportable events and study closures • Monitors regulatory documentation and timely completion of submissions and approvals • Ensures compliance with GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies and departmental SOPs • Prepares for, manages and responds to audits and inspections • Leads responses to audit findings and coordinates CAPA plans • Oversees regulatory projects and workflows, monitoring timelines, deliverables, risks and barriers • Allocates regulatory staff resources across study portfolios and departmental priorities • Communicates regulatory status, risks and compliance issues to investigators, study teams and leadership • Monitors regulatory changes and leads related process or policy changes • Supports protocol development, study start-up and close-out activities • Maintains relationships with stakeholders, sponsors, IRB and regulatory agencies • Coordinates regulatory metrics, reports and compliance analyses • Participates in research compliance and regulatory affairs meetings and committees • Assists leadership with regulatory policies and quality initiatives • Manages special regulatory projects and performs 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 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/governmental regulations and guidelines related to clinical research • Knowledge of the elements of Good Clinical Practices • Ability to work Monday through Friday, 8 AM - 4:30 PM

🏖️ Benefícios

• Benefits Eligible • Paid Time Off programs • Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability • Flexible Spending Accounts for eligible health care and dependent care expenses • Family benefits such as adoption assistance and paid parental leave • Defined contribution retirement plans with employer match and other financial wellness programs • Educational Assistance Program • Competitive compensation • Programs that invest in career development • Opportunity for annual increases based on performance • Incentive pay for select positions • Premium pay such as shift, on call, and more based on a teammate's job