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 …