Editor I, Consent Form Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Assists the IRB Services department with the evaluation of incoming submissions and the preparation of informed consent forms (ICFs).

• Conducts a thorough pre-review of new and updated consent forms to ensure compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidelines, and adherence to Advarra Standard Operating Procedures and Work Instructions.

• Edits new and revised consent forms to guarantee regulatory compliance and conformity with Advarra document standards.

• Incorporates negotiated Sponsor language into consent form documents as mandated by client agreements specified in mandatory language documents or MLDs.

• Collaborates with Board members and staff to incorporate all necessary revisions to the consent form from various stakeholders.

• Stays informed about U.S. and/or Canadian Regulations and Guidelines regarding Human Subject Protections, drug research, device research, and cosmetic research.

• Completes standard Human Subjects Research Training, such as CITI, on a recurring schedule as determined by management.

• Undertakes organizational training as required by management.

• Participates in one IRB meeting each month to deepen knowledge and understanding of IRB processes (two meetings per month during the initial training phase).

⛳️ Requirements

• A minimum of 2 years of experience in technical, medical writing and/or editing.

• An Associate's degree.

🏝️ Benefits

• Health coverage.

• Paid holidays.

• Variable bonus.