Regulatory Services Manager - National Center for Clinical Trials (NCCT)

Wake Forest University School of Medicine; Allenton (WI); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Wake Forest University School of Medicine is seeking a Regulatory Services leader for the NCCT to oversee regulatory staff and ensure compliance across numerous clinical trials. The role focuses on IRB submissions, HIPAA compliance, audit readiness, and CAPA management, guiding policy implementation and improving research operations.

The position requires a Master’s degree in a relevant field and 3+ years of management experience in a medical/research environment, with travel to affiliate sites

Competenze

• Excellent verbal and written communication skills.
• Demonstrates knowledge of scientific and statistical principles.
• Ability to travel to affiliate sites, clinical sites and national meetings.
• Familiar with institutional/governmental regulations and guidelines related to clinical research including GCP.

Mansioni

• Provides overall administrative direction and coordination of Regulatory Services for NCCT.
• Oversees regulatory submissions and approvals, including IRB reviews, amendments, and study closures.
• Ensures compliance with applicable regulations (GCP, ICH, FDA, HIPAA, state/federal).
• Leads audit preparations and CAPA development and tracking.
• Manages multiple regulatory projects and timelines, allocating staff resources.
• Communicates regulatory status and risks to investigators, teams, and leadership.
• Keeps abreast of regulatory changes and implements policy/process updates.

Conoscenze

Excellent verbal and written comms

Knowledge of scientific & statistical

Travel to affiliate sites & national会议

Familiar with regulations (GCP/FDA/HIP

Formazione

Master's in Health Admin, Nursing, Business or Basic Science

Descrizione del lavoro

Job Summary

The Advocate Health National Center for Clinical Trials (NCCT) serves as an innovative platform to accelerate the conduct of clinical trials and the translation of scientific discoveries into meaningful improvements in patient care. NCCT provides centralized services for patient recruitment and enrollment, trial administration and follow-up, and the generation of real-world data and evidence.

Job Summary

The Advocate Health National Center for Clinical Trials (NCCT) serves as an innovative platform to accelerate the conduct of clinical trials and the translation of scientific discoveries into meaningful improvements in patient care. NCCT provides centralized services for patient recruitment and enrollment, trial administration and follow-up, and the generation of real-world data and evidence.

Under administrative review, provides overall administrative direction and coordination of Regulatory Services for NCCT clinical research, ensuring compliance with institutional, IRB, federal and other applicable regulatory requirements across a large number of clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, HIPAA compliance and regulatory communications. Develops, implements and enforces policies, procedures and tools to support compliant and efficient research operations. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.

Functions

• Provides administrative oversight and direct leadership to regulatory staff, including hiring, training, performance management, coaching, and professional development; supports remote training and ongoing regulatory education.
• Oversees regulatory submissions and approvals, including initial and continuing IRB reviews, amendments, reportable events, and study closures; monitors timely completion and maintenance of regulatory documentation.
• Ensures all regulatory activities are conducted in compliance with applicable regulations and standards, including GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and departmental SOPs.
• Prepares for, manages and responds to internal and external audits and inspections; leads responses to audit findings and coordinates development, implementation, and tracking of corrective and preventive action (CAPA) plans.
• Provides oversight of multiple regulatory projects and workflows, monitoring progress against timelines and deliverables and addressing risks or barriers.
• Allocates regulatory staff resources appropriately to support study portfolios and departmental priorities.
• Communicates regulatory status, risks, and potential compliance issues to investigators, study teams, and leadership; escalates concerns as appropriate.
• Monitors regulatory changes and guidance (e.g., FDA, NIH, HHS, HIPAA) and evaluates impact on clinical research operations; leads implementation of process or policy changes to maintain compliance.
• Supports protocol development and study start‑up and close‑out activities by advising on regulatory feasibility, documentation requirements, and transitions as funding or study status changes.
• Establishes and maintains effective working relationships with institutional stakeholders, sponsors, IRB, and regulatory agencies to support compliant research conduct.
• Coordinates preparation of regulatory metrics, reports and compliance analyses, identifying trends, risks, and opportunities for process improvement.
• Participates in departmental, institutional, and external meetings or committees related to research compliance and regulatory affairs.
• Assists leadership in implementing institutional and departmental regulatory policies and quality initiatives.
• Manages special regulatory projects and performs other related duties as assigned.

Education, Experience And Certifications

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.

Skills/Qualifications

• Excellent verbal and written communication skills
• Demonstrates knowledge of scientific and statistical principles
• Ability to travel to affiliate sites, clinical sites and national meetings
• Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices

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