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