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.