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 has as its core function the institutional review board (IRB) review of
all human subject’s research from survey research to first-in-human research
sponsored by pharmaceutical companies, biotech companies, institutions,
hospitals as well as clinics and private physician offices. Within the IRB, the
regulatory department is responsible for the expedited review of research, the
full board review of research and the drafting and writing of the meeting
minutes. The regulatory department also collaborates with other parts of the
organization on thought leadership, client guidance, and operational
efficiencies.
Affiliated Board Members (ABM) are full-time Advarra employee board members who
conduct IRB reviews on behalf of the organization. Based on educational
background, experience, and expertise ABMs can be designated as either
scientific or non-scientific and workload is distributed accordingly. A
non-scientific ABM is a board member who does not have a scientific educational
background or significant professional experience in a scientific field but has
a strong understanding of research regulations and guidance.
Job Duties & Responsibilities
Maintain superior level knowledge of, and ensure Review Board compliance
with, regulatory requirements, Advarra’s Board Standard Operating Procedures
and Organizational Policies and Procedures. Help ensure the timely execution
of the core review activities of the Institutional Review Board, while
preserving the highest quality of professionalism and regulatory compliance
Be a resource to answer questions and help to solve day-to-day challenges
whether in collaboration with Advarra staff or other board members
Assist as necessary with the triaging and review of submissions for expedited
or full board review
Attend full board meetings and present protocol related issues as needed
Identify to senior regulatory staff areas that would benefit from guidance,
inconsistencies in Board reviews, and other like issues
Consult, as necessary, with sponsors, investigators, CROs on clinical and
regulatory affairs
Work with Regulatory Leadership to identify membership needs and to help
develop Board members to ensure consistency of Review Board related
activities
Enhance and encourage a work atmosphere centered on accountability through
motivation, team building, training, mentoring, collaboration, and respect to
create a highly efficient and successful workplace
Location
This role is open to candidates working remotely in the United States.
Basic Qualifications
Bachelor’s Degree
One (1)+ years of IRB or Clinical Research Industry experience preferred, OR
minimum 3 years’ experience in healthcare within the last 6 years
Preferred Qualifications
Master’s Degree
Certified IRB Professional (CIP) certification
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 $58,495 – $96,517. 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.