Senior Editor, Consent Form Development

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

📋 Description

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

• Perform detailed pre-reviews of both new and amended consent forms to ensure compliance with FDA, HHS, Health Canada, TCPS2, and ICH GCP regulations.

• Revise consent forms to meet regulatory standards and align with Advarra's guidelines.

• Implement negotiated sponsor and site language in accordance with client agreements and required documentation.

• Work collaboratively with board members and staff to integrate edits from stakeholders.

• Execute quality-control checks on informed consent for oneself and peers.

• Provide mentorship to new team members as needed.

• Continuously enhance knowledge of U.S. and/or Canadian regulations and guidelines regarding human subjects.

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

• Participate in one IRB meeting monthly, or two per month during the initial training period.

• Recommend process enhancements to management.

• Carry out additional duties as assigned.

⛳️ Requirements

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

• Bachelor’s degree.

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

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

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

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

• Preferred: Over 1 year of experience with IRB processes.

• Preferred: Certified IRB Professional (CIP) or achievement of CIP certification within two years of becoming eligible.

• Comprehensive understanding of human subjects research and informed consent processes.

• Knowledgeable in scientific and medical terminology, with the capacity to translate complex information into layman's terms.

• Competent in editing technical and/or medical documents.

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

• Skilled at managing multiple editing assignments under shifting demands and priorities.

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

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

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

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

🏝️ Benefits

• Potential for a variable bonus in addition to the base salary.

• Health insurance coverage.

• Paid holidays.

• Opportunity for remote work within the United States.