Research Compliance Manager

JOB SUMMARY
The Research Compliance Manager will lead the development and implementation of research compliance programs within Innovo Research. This role is responsible for ensuring that research training activities and audits adhere to federal, state, and institutional regulations, while fostering a proactive compliance culture. In addition to auditing and regulatory responsibilities, the manager will supervise compliance specialists, work closely with senior leadership, and drive strategic initiatives to mitigate compliance risks across the organization. The Research Compliance Manager will also be responsible for developing and refining policies and SOPs, spearheading compliance training programs, and supporting the network through regulatory changes, audits, and inquiries.

RESPONSIBILITIES

• Supervise and mentor Research Compliance Specialists and other compliance staff, ensuring the team’s effectiveness and professional development.
• With senior leadership oversight, leads the design, development, and implementation of research compliance programs, ensuring alignment with organizational goals and regulatory requirements.
• Lead internal audits of research protocols, billing processes, and documentation to ensure compliance with SOPs, federal regulations, and Good Clinical Practice (GCP) guidelines.
• Design and implement comprehensive compliance training programs for investigators, research staff, and leadership, fostering a strong culture of regulatory adherence.
• Lead the creation, review, and updates of compliance policies, SOPs, and educational materials to reflect current regulatory and institutional requirements.
• Partner with Start-up and Clinical Research Operations stakeholders to ensure studies have necessary documentation at study start, address compliance risks and ensure seamless integration of compliance strategies.
• Stay abreast of new developments in research compliance, and proactively communicate these changes to stakeholders, adjusting programs and policies as needed.
• Manage investigations and corrective actions related to compliance violations, working closely with investigators, clinical teams, and senior leadership.
• Develop and maintain compliance metrics and/or quality assurance reports for sites, providing regular reports to senior leadership and identifying trends to inform future initiatives.
• Support research sites during regulatory agency inspections, overseeing responses to inquiries, audits, and investigations.
• Promote a culture of accountability and ethical conduct throughout the site network, advocating for continuous improvement in compliance practices.
• Perform other duties as assigned by senior leadership.

• 3-5 years of experience in research compliance, auditing, or clinical trial monitoring, with progressive responsibility in a management or leadership role.
• Bachelor’s Degree required; advanced degree or certifications (e.g., Certified Clinical Research Professional, Certified IRB Professional) preferred.
• Strong understanding of clinical research regulations (FDA, GCP, HIPAA), billing compliance, and risk management.
• Excellent organizational, critical thinking, and leadership skills. Ability to manage multiple projects and stakeholders in a fast-paced environment.
• Demonstrated ability to build relationships with diverse teams and guide them through complex regulatory challenges.
• Proficient in Microsoft Office applications and research compliance software/tools.
• Some travel required for site visits, audits, and external meetings.

  BENEFITS (full time)

  • Competitive salary
  • Health Insurance
  • Dental Insurance
  • Disability Insurance
  • Life insurance
  • Paid Time Off
  • Vision Insurance

   

• WORKING CONDITIONS