Editor II, Consent Form Development

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

📋 Description

• Perform thorough pre-reviews of new and updated consent forms to ensure compliance with FDA, HHS, Health Canada, TCPS2, ICH GCP, and Advarra procedures.

• Revise and edit consent forms to align with regulatory requirements and Advarra's documentation standards.

• Integrate agreed-upon Sponsor language as per client contracts.

• Work collaboratively with Board members and staff to incorporate feedback from stakeholders.

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

• Complete ongoing human subjects research training.

• Attend at least one IRB meeting each month, or two during the initial training phase.

• Propose process improvements to management.

• Carry out additional assigned responsibilities.

⛳️ Requirements

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

• Bachelor's degree required.

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

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

• Familiarity with Excel, PowerPoint, Slack or similar messaging applications, Zoom or RingCentral for remote meetings, and web-based proprietary software.

• Ability to communicate effectively and professionally in English, both verbally and in writing.

• Strong interpersonal skills and a commitment to customer service.

• Knowledge of human subjects research and informed consent processes.

• Understanding of scientific/medical terminology with the capability to translate complex information into layman's terms.

• Competence in editing technical and/or medical documents.

• Ability to read and understand advanced technical/medical documents, including medical protocols and informed consent forms.

• Capability to manage multiple editing projects under varying demands and priorities.

• High attention to detail, accuracy, thoroughness, and strong problem-solving skills.

• Ability to follow both written and verbal instructions while working independently.

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

• Must meet organizational training requirements.

• Ability to remain seated or standing for extended periods at a stationary workstation.

• Ability to regularly lift, carry, and lower objects weighing up to 10 lbs.

🏝️ Benefits

• Eligibility for variable bonuses.

• Comprehensive health coverage.

• Paid holidays.