Coordinator II, DMC/EAC

Advarra•United States of America,

12d•$54,029 - $89,158•Remote

About The Position

Advarra’s Biostatistical Services team provides oversight of clinical research through Data Monitoring Committees (DMCs) and Endpoint Adjudication Committees (EACs). The DMC/EAC Coordinator II provides administrative and operational support for committee activities, including member engagement and onboarding, meeting management, minutes, preparation of materials, result letters, and other aspects of administering the committee process. The role also provides general administrative support and backup coverage for other operations staff. This position is open to candidates working remotely in the United States. It involves coordinating with committee members, sponsors, project managers, safety teams, and consultants; organizing study information and documents; managing committee meetings and communications; and supporting study close-out. The position may also assist with departmental and company projects related to Biostatistical Services and provide coverage to other teams as needed.

Requirements

Bachelor’s degree, or an associate degree with at least 2 years of industry or office administration experience.
At least 1 year of specific experience in regulatory committee administration, such as Coordinator I experience.

Nice To Haves

At least 2 years of DMC, EAC, or clinical research industry experience.
Detail orientation and problem-solving skills.
Effective verbal and written communication skills, with attention to detail.
Strong interpersonal skills and ability to provide high levels of customer service.
Ability to follow instructions, work independently, and plan, organize, schedule, and complete work amid competing deadlines and priorities.
Ability to adapt to changes in office technology, equipment, or processes.
Consistent and dependable attendance and quality and quantity of work.
Advanced knowledge and understanding of regulatory requirements and applications.
Ability to perform tasks consistently and at a superior level of volume and efficiency.
Ability to multitask and switch between projects while maintaining attention to detail.
Ability to sit or stand for extended periods at a stationary workstation.
Ability to regularly carry, raise, and lower objects weighing up to 10 pounds.
Ability to learn and comprehend basic instructions, focus on assigned tasks, and communicate verbally, including listening, understanding, responding, and speaking.

Responsibilities

Organize meetings with DMC/EAC committee members and collect and post data packets for their review and meeting preparation.
Communicate with sponsor company project managers and safety teams to ensure information, such as serious adverse events and enrollment updates, is provided to committees on time.
Create study update reports and submit them to committee members.
Create meeting reports for board-member signatures through transcription.
Prepare notes to charters and memos to document committee and sponsor actions.
Maintain communication tracking sheets and flow sheets for committee management.
Maintain secure extranet accounts.
Plan web conferences, teleconferences, and in-person meetings, including same-day and overnight meetings.
Organize and post data packets to the extranet and archive study data in computer files.
Manage stipend and expense requests, prepare payment reports, and submit them for payment.
Archive final documents for study close-out.
Present documents for signatures, collect signature pages, and incorporate them into final reports.
Fulfill committee and sponsor project manager requests within scope and alert management to requests outside 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 videoconference meetings.
Ensure meeting attendees have the information, tools, and documents needed to participate effectively.
Record and transcribe meeting minutes, accurately documenting required components under applicable regulatory requirements and Advarra procedures.
Assist with department and company projects related to Biostatistical Services.
Provide coverage within the team and other teams as needed.
Check digital images received from sponsors through sponsor platforms for detail and quality.
Use electronic adjudication systems to gather data and create documents.
Perform other duties as assigned.