Senior Editor, Consent Form Development

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

📋 Description

• Assist the IRB Services department by evaluating incoming submissions and creating informed consent forms utilized in human subjects research.

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

• Revise new and updated consent forms to meet regulatory standards and align with operational requirements.

• Implement negotiated sponsor and site language in accordance with client agreements and essential language documents.

• Work collaboratively with board members and staff to integrate necessary stakeholder revisions.

• Conduct quality-control checks on informed consent documents for personal and other editors’ submissions.

• Provide mentorship to new team members as requested.

• Enhance and maintain knowledge of regulations regarding human subject protections, as well as drug, device, and cosmetic research.

• Complete ongoing training in human subjects research and organizational courses.

• Participate in one IRB meeting monthly, or two during the initial training phase.

• Suggest process improvements to management.

• Undertake additional assigned responsibilities.

⛳️ Requirements

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

• Bachelor’s degree required.

• Background in writing and/or editing consent forms or related research documents.

• Skilled in word processing and editing, including the use of Tracked Changes and Compare Merge features.

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

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

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

• Competent in editing technical and/or medical documents.

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

• Proficient in managing multiple editing projects with competing demands and priorities.

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

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

• Certification as an IRB Professional (CIP) or completion of CIP within two years of eligibility is preferred.

• Over 1 year of IRB experience is preferred.

• Familiarity with human subjects research and informed consent is preferred.

• Completion of standard Human Subjects Research Training, such as CITI, is required.

• Capability to sit or stand for prolonged periods at a stationary workstation.

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

• Aptitude for learning and comprehending basic instructions.

• Ability to concentrate and attend to tasks and responsibilities.

• Proficient in verbal communication, listening, understanding, responding, and speaking.

🏝️ Benefits

• Eligibility for variable bonuses.

• Health insurance coverage.

• Paid holidays.

• Commitment to equal opportunity and an inclusive workplace.

• Reasonable accommodations for applicants with disabilities.

• Option for remote work arrangements.