Coordinator II, DMC/EAC

Job Overview Summary

Advarra is a clinical research compliance company. Biostatistical Services focuses on oversight of research through Data Monitoring Committees (DMC) and Endpoint Adjudication Committees (EAC). The DMC/EAC Coordinator II provides administrative and operations support to the overall operations of DMC and EACs. Support is provided by administering DMC/EAC member engagement, onboarding, meeting management, minutes, preparation of materials, result letters, and all other aspects of administering the DMC / EAC committee process. This position will also offer general administrative support and back-up coverage for other operations staff.

Job Duties & Responsibilities

• Works directly with DMC/EAC Committee Members to organize meetings, collect and post data packets for Committee Members review meeting preparation.
• Communicates as directed with Sponsor Company project manager and safety teams to ensure all information is being provided to the DMC/EAC in a timely manner (i.e., SAEs, enrollment, etc.).
• Creates study update reports with information received and submits to Committee Members.
• Creates meeting reports for signature by Board Members via transcription.
• Creates notes to charter and memos as necessary to record action within the Committee and with the Sponsor.
• Maintains communication tracking sheets and flow sheets to aid in Committee management.
• Maintains secure extranet accounts.
• Meeting planning – web/teleconferences, in-person same day, in-person overnight.
• Data management – organize and post data packets to the Extranet and archives all data in computer files by study.
• Manages stipend and expense requests, creates payment reports and submits them for payment.
• Archives final documents for study close-out.
• Presents documents for signatures, collects signature pages and integrates into final reports.
• Fills any special requests of the DMC/EAC and Sponsor Project Manager within scope and alerts management when requests are outside of scope.
• Provide administrative support for DMC / EAC meetings.
• Facilitate written and oral communications with members and consultants for expert and consultation reviews.
• Plan, Schedule and manage video-conference meetings.
• Ensure meeting attendees are equipped with the information, tools, and documents necessary to effectively participate in assigned meetings.
• Record and transcribe meeting minutes, ensuring components as required by the appropriate regulatory body and Advarra operating procedures are accurately identified and documented.
• Assist in Department and Company projects as they relate to Biostatistical Services.
• Provide coverage within the team and other teams as needed.
• Attention to detail and quality control of digital images received from Sponsor via Sponsors platform.
• Ability to work within the electronic adjudication systems to gather data and create documents.
• Other duties as assigned.

Location

This role is open to candidates working remotely in the United States.

Basic Qualifications

• Bachelor’s Degree or Associates Degree with 2+ years industry or office administration experience
• 1+ years specific experience in regulatory committee administration (e.g., Coordinator I experience)

Preferred Qualifications

• 2+ years of DMC, EAC or Clinical Research Industry experience
• Detail-oriented and possess problem solving skills
• Ability to communicate effectively verbally and in writing, with attention to detail
• Excellent interpersonal skills to work effectively with others and provide high levels of customer service
• Ability to follow instructions and work independently as required; plan, organize, schedule and complete work within competing deadlines and priorities
• Ability to adapt to changes in office technology, equipment, and/or processes
• Demonstrated consistency and dependability in attendance, quantity, and quality of work
• Exhibit an advanced knowledge and understanding of regulatory requirements and applications
• Perform tasks in a consistent and superior manner in terms of volume and efficiency
• Must be able to multi-task and switch to-and-from projects easily and with attention to detail