Editor II, Consent Form Development

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

📋 Description

• Perform precise pre-reviews of newly created and revised consent forms to ensure regulatory compliance with FDA, HHS, Health Canada, TCPS2, ICH GCP, and Advarra procedures.

• Revise consent forms to meet regulatory standards and Advarra document specifications.

• Integrate negotiated Sponsor language into consent forms as per client agreements.

• Work in collaboration with Board members and staff to include stakeholder edits.

• Continuously update and enhance knowledge of U.S. and/or Canadian regulations and guidelines related to human subject protections, as well as drug, device, and cosmetic research.

• Complete ongoing Human Subjects Research Training, such as CITI.

• Meet organizational training requirements.

• Participate in IRB meetings to gain insight into IRB processes.

• Propose process improvements to management.

• Execute other assigned responsibilities.

⛳️ Requirements

• A minimum of 1 year of experience in technical/medical writing and/or editing.

• A Bachelor’s degree.

• Experience in writing and/or editing consent forms or other research documents.

• Proficient in word processing and editing, including Tracked Changes and Compare Merge functionalities.

• Familiarity with Excel, PowerPoint, Slack, Zoom or RingCentral, and web-based proprietary software.

• Strong ability to communicate clearly and professionally in English, both verbally and in writing.

• Knowledge of human subjects research and informed consent processes.

• Understanding of scientific/medical terminology, with the ability to translate scientific/medical information into layman’s terms.

• Capability to edit technical and/or medical documents.

• Ability to read and comprehend advanced technical/medical documentation.

• Proficient in managing multiple editing projects amidst conflicting demands and priorities.

• Exceptional attention to detail, accuracy, and thoroughness.

• Strong problem-solving skills.

• Ability to follow both written and verbal instructions and work independently.

• Must complete Human Subjects Research Training, such as CITI.

• Availability to attend at least one IRB meeting per month (two per month during initial training).

• Capability to sit or stand for extended periods and lift, raise, and lower objects weighing up to 10 lbs.

🏝️ Benefits

• Eligibility for variable bonuses.

• Health insurance coverage.

• Paid holidays.

• Commitment to equal opportunity and an inclusive workplace.