Sr. Editor, 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. In addition, the Senior Editor may mentor new editors and complete projects as defined by management.

Job Duties & Responsibilities

• Conduct accurate pre-reviews of new and revised consent forms to ensure regulatory compliance with FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and Advarra SOPs
• Edit consent forms to align with Advarra operational standards and incorporate negotiated Sponsor and site language
• Collaborate with stakeholders to incorporate necessary edits to consent forms
• Perform informed consent quality control checks for self and others
• Mentor new team members
• Maintain and increase regulatory knowledge in Human Subject Protections, drug research, device research, and cosmetic research
• Complete standard Human Subjects Research Training (e.g., CITI) on a recurring cycle determined by management
• Attend IRB meetings regularly to enhance understanding of IRB processes
• Offer suggestions for process improvements to management
  
  
  

Location: US Remote

Basic Qualifications

• Bachelor’s degree or associate degree
• Certified IRB Professional (CIP) or completion of CIP within two (2) years of eligibility
• Minimum of two years of experience in technical/medical writing and/or editing; experience writing and/or editing consent forms or other research documents
  
  
  

Preferred Qualifications

• One year IRB experience
  
  
  

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
  
  
  

US Equal Employer Opportunity (EEO) Statement)

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 $49,200 - $83,600. 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.