Coordinator II, DMC/EAC

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

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

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary workstation

• Regularly carry, raise, and lower objects of up to 10 Lbs.

• Learn and comprehend basic instructions

• Focus and attention to tasks and responsibilities

• Verbal communication; listening and understanding, responding, and speaking

Advarra is an equal opportunity employer that is committed to providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information, or any other status or characteristic protected by federal, state, or local law.

Pay Transparency Statement

The base salary range for this role is $54,029 - $89,158. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.