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 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  

Minimum of 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 year 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 identify), 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.