Team Lead, Meeting Coordination

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 Team Lead demonstrates expert understanding of the Meeting Coordinator (MC) role and responsibilities and provides mentorship and training to MCs. In addition, Team Lead coordinates the IRB meeting workflow by reviewing incoming submissions, assigning reviews to Board members, coordinating IRB meeting space/platform and preparing informed consent forms (ICFs) in adherence to all applicable regulations and timelines. Team Lead also completes projects as defined by management.

Job Duties & Responsibilities

Mentors and trains MCs:

• Reviews work for compliance with policies, Standard Operating Procedures (SOPs), and guidance documents
• Trains, supports and evaluates Editors
• Mentors new Editors
• Available as contact for questions from MC and Client Services staff:
• Coordinates with other team members and Managers to ensure consistency in responses.

Coordinates the IRB meeting workflow:

• Reviews submissions for full board assignment to ensure readiness for review
• Assigns submissions to upcoming IRB Meetings
• Sends assignments and assignment updates to reviewers in CIRBI
• Facilitates clarification of protocol, safety, and consent issues in collaboration with the Chair
• Sends clarifications between Client Services, Board reviewers and Clients.
• Prepares Meeting and Post meeting ICFs to encompass all Board Member concerns and edits
• Prepares proposed meeting determinations for Chair review Hosts web platform for IRB meetings
• Provides support to Chairs and Board Members prior to and during the meeting, as requested, to ensure regulatory compliance
• Finalizes and uploads Board determinations to CIRBI
• Supports the Board and proposes solutions for 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
• Challenges or assists in clarifying opinions and questions of concern in an IRB meeting
• Works with client services on any special issues that need to be reported to the IRB
• Analyzes and suggests changes to IRB review methods

Conducts an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions:

• Edits new and revised consent forms, using the ICF and HIPAA Checklist, to ensure regulatory compliance and alignment with Advarra operational standards
• Applies negotiated Sponsor and site language to consent form documents as required by client agreements and documented in mandatory language documents or MLD’s.
• Collaborates with Board members and staff to include all necessary edits to the consent form from the various stakeholders
• Completes informed consent quality control check for themselves and others
• Maintains and increases individual regulatory knowledge to assist with organizational compliance:
• Maintains and increases knowledge of U.S. and/or Canadian Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research
• Completes standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
• Completes organizational training as