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
This role conducts Quality Control (QC) activities on IRB and staff
documentation to ensure accuracy compared to primary sources and adherence to
all applicable Advarra quality control standards, federal regulations, and
timelines. Requires independent judgment, attention to detail and
accountability. Works with the Manager and leadership team
to identify strategies and methods to achieve organizational goals.
Job Duties & Responsibilities
Effectively performs the duties of a Quality Control
Coordinator II, demonstrating strong attention to detail, and sound judgment
Reviews and critically analyzes documents for accuracy in content for
assigned submission types
Provides clear feedback to communicate errors to Research Services
staff regarding missing and/or incomplete elements
Accomplishes daily workload priorities with flexibility and adaptability
Executes procedures in compliance with internal quality standards and
external regulations
Support supervisor or director vision of team performance
through timely processing of delegated tasks, appropriate escalation of
workflow concerns, and proactive process improvement suggestions
Participates in team and department professional and personal development
initiatives while maintaining a high level of integrity through cooperative
and respectful interactions with colleagues
Performs quality control of recruitment, subject facing, translated and
generic material submissions as well as initial site reviews and site
modifications (e.g., Change of Investigator, Sub-Investigator, Location,
Disclosure of Conflict of Interest, or Informed Consents [including
propagated modifications]; HIPAA or eConsent requests). Also performs quality
control on study level Protocol or Product Information modifications that do
not impact Informed Consent templates.
Performs other duties as assigned
Location
This role is open to candidates working remotely in the United States.
Basic Qualifications
Bachelor’s degree in health science or related field, or equivalent
combination of education and experience
One (1)+ year(s) of IRB, clinical research, or quality control experience
Basic knowledge of Federal laws and guidelines pertaining to Human Subjects
Research Protection
Proficient with MS Word and Outlook
Familiar with Excel, PowerPoint, direct messaging applications such as Slack,
remote meeting applications such as Zoom, and web-based proprietary
software
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, 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 - $89,148. 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.