Editor I, Consent Form Development

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

Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subject research.  

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, including: 

• Editing new and revised consent forms to ensure regulatory compliance and alignment with Advarra document standards 

• Applying negotiated Sponsor language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s 

• Collaborating with Board members and staff to include all necessary edits to the consent form from the various stakeholders 

• Keeping up to date with U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections, drug research, device research, and cosmetic research 

• Completing standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management 

• Completing organizational training as required by management 

• Attending one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period) 

Location  This role is open to candidates working remotely in the United States. 

Preferred Qualifications  

• 2+ years of experience in technical, medical writing and/or editing 

• Associates degree  

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 diversity, equity and inclusion and 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.  Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment. 

Pay Transparency Statement

The base salary range for this role is $50,000 - $66,974. 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.