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 protocols.

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

• Integrate negotiated Sponsor language into consent forms in accordance with client agreements.

• Work collaboratively with Board members and staff to include stakeholder feedback.

• Continuously expand knowledge of U.S. and/or Canadian regulations and guidelines regarding human subject protections, as well as drug, device, and cosmetic research.

• Participate in at least one IRB meeting each month, or two per month during initial training.

• Provide suggestions for process improvements to management.

• Carry out other assigned responsibilities.

⛳️ Requirements

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

• A Bachelor’s degree.

• Proven experience in writing and/or editing consent forms or other research-related documents.

• Strong proficiency in word processing and editing tools, including Tracked Changes and Compare Merge functions.

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

• Excellent verbal and written communication skills in English.

• Understanding of human subjects research and the informed consent process.

• Knowledge of scientific and medical terminology, with the ability to translate complex information into layman's terms.

• Capability to edit technical and/or medical documents effectively.

• Proficient in reading and understanding advanced technical or medical documents, including medical protocols and informed consent forms.

• Ability to manage multiple editing projects amidst competing demands and priorities.

• Strong attention to detail, accuracy, thoroughness, and effective problem-solving abilities.

• Competence in following both written and verbal instructions, with the ability to work independently as needed.

• Completion of standard Human Subjects Research Training, such as CITI, on a recurring basis as determined by management.

• Adherence to organizational training requirements as directed by management.

• Capacity to sit or stand for extended periods at a stationary workstation.

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

🏝️ Benefits

• Variable bonus eligibility in addition to base salary.

• Health insurance coverage.

• Paid holidays.

• Reasonable accommodations for applicants with disabilities.

• An inclusive and collaborative workplace environment.