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
Sr Editor, Consent Form Development supports the IRB Services department in the
review of incoming submissions and preparation of informed consent forms (ICFs)
used in the conduct of human subjects research. In addition, the Senior Editor
may mentor new editors and complete projects as defined by management.
Job Duties & Responsibilities
Conduct an accurate pre-review of new and revised consent forms in regulatory
compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH
GCP guidance, and operational compliance with Advarra Standard Operating
Procedures and Work Instructions
Edit new and revised consent forms to ensure regulatory compliance and
alignment with Advarra operational standards
Apply negotiated Sponsor and site language to consent form documents as
required by client agreements documented in mandatory language documents or
MLD’s
Collaborate with Board members and staff to include all necessary edits to
the consent form from the various stakeholders
Complete informed consent quality control check for yourself and others
Mentor new team members, as requested
Maintain and increase individual regulatory knowledge to assist with
organizational compliance:
Maintain and increase knowledge of U.S. and/or Canadian Regulations and
Guidelines in the area of Human Subject Protections, drug research, device
research, and cosmetic research
Complete standard Human Subjects Research Training, such as CITI, on a
repeating cycle determined by management
Complete organizational training as required by management
Attend one IRB meeting per month to enhance knowledge and understanding of
IRB processes (two meetings per month during the initial training period)
Offer process improvement suggestions to management, as applicable
Other duties as assigned
Location
This role is open to candidates working remotely in the United States.
Basic Qualifications
2+ years of experience in technical/medical writing and/or editing in
addition to a Bachelor’s degree
Experience writing and/or editing consent forms or other research documents
Proficiency in Word processing and editing (including use of Tracked Changes
and Compare Merge functions)
Familiar with Excel, PowerPoint, direct messaging applications such as Slack,
remote meeting applications such as Zoom or RingCentral, and web-based
proprietary software
Preferred Qualifications
1+ years of IRB experience
Experience writing and/or editing consent forms or other research documents
Certified IRB Professional (CIP) or completion of CIP within two (2) years of
eligibility
Ability to communicate clearly and professional in English, both verbal and
written skills
Excellent interpersonal skills to work professionally and effectively with
others and provide high levels of customer service
In-depth knowledge of matters regarding human subjects research and informed
consent
Familiar with scientific/medical terminology and able to convert
scientific/medical information to lay terms
Ability to edit technical and/or medical documents
Ability to read and comprehend advanced technical/medical documents such as
medical protocols and informed consent forms
Ability to manage various editing projects under conflicting demands and
priorities
Dependably produces high quality work
Must have high level of attention to detail, accuracy and thoroughness;
problem solving skills
Ability to follow written and verbal instructions and work independently
as required
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 $66,767 - $116,089. 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.