Director, IRB Services

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Overview Summary

The Director, IRB Services supports the other Directors of IRB Services and the Vice President, Global Review, in ensuring accurate, consistent and efficient departmental and inter-departmental operations. The Director oversees and provides leadership to all areas of IRB Services (Meeting Coordination and Consent Form Development). The Director works with team management and staff, and collaboratively with inter-departmental stakeholders to establish and maintain operational success as defined by Advarra’s Corporate Leadership Team.

Job Duties & Responsibilities

• Provide leadership and direction through operational and organizational change.
• Supervises the IRB Services Managers and Team Leads (MC and CFD):
  • Review work for compliance with policies, SOPs, and guidance documents
  • Resolve escalated issues and concerns brought by the team
  • Coordinates high-level aspects of training and development for IRB Services
  • Collaborates cross-departmentally to ensure efficient workflow and process development
  • Available as SME resource for all IRB Services questions internally/cross-departmentally, and for client questions related to the IRB Services processes.
  • Support the broader operational success of IRB Services.
  • Guide IRB Services’ management and staff in their execution of team-based and departmental-wide goals.
  • Ensure IRB Services meets service delivery obligations.
  • Ensure quality assurance processes are sufficient to maintain departmental goals.
  • Perform regular and annual performance review of management staff in IRB Services.
• Represent IRB Services, and problem-solve collaboratively, on inter-departmental projects and meetings.
• Supports and represents IRB services at all Regulatory meetings including Chairs, Affiliated Board members and others.
• Represents IRB Services in audits.
• Assign and oversee projects delegated to select areas of management and staff.
• Develops and maintains IRB Services work instructions to ensure coordinated and timely instruction for all IRB Services responsibilities and tasks
• Develops, maintains and reports to the Vice President, Global Review metrics specific to the performance of IRB Services
• Assists the Vice President, Global Review to ensure that the IRB adheres to all applicable Federal regulations and adheres to timelines:
  • Keeps informed on US and Canadian Federal Regulations and Guidelines in Human Subject Protections
  • Independently solves problems and issues by applying US and Canadian Federal Regulations, FDA Info Sheets, IRB Written Procedures and other resources
  • Manages complex and challenging issues in the IRB meetings
  • Identifies issues for the IRB and the IRB chair to address through high-level understanding of protocols
  • Offers suggestions and ideas for process improvement to Vice President, Global Review
  • Works with client services on any special issues that need to be reported to the IRB
  • Analyzes and suggests changes to IRB review methods
• Works with the Vice President, Global Review to identify strategies and methods to achieve organizational goals:
  • Assists with the revision of IRB Written Procedures when required.
  • Serves as contact for Client Services teams for operational issues.
  • Assists with development of IRB Services work instructions.