Sr Editor, Consent Form Development

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Editor, Consent Form Development based in United States.** This is a specialized editing role supporting the development and review of informed consent forms used in human subjects research. You will help ensure that new and revised consent documents meet applicable regulatory requirements while remaining clear, accurate, and aligned with established operational standards. The role combines technical and medical editing expertise with knowledge of clinical research, human subject protections, and informed consent requirements. You will collaborate with Institutional Review Board (IRB) members, staff, sponsors, sites, and other stakeholders to incorporate required language and resolve document requirements. As a senior member of the team, you will also contribute to quality control, mentor newer editors, and share recommendations for improving processes. The position offers an opportunity to deepen expertise across United States and Canadian research regulations while working on documents that directly support ethical and compliant clinical research. This fully remote opportunity is well suited to a detail-oriented professional who enjoys independent work, complex technical content, and making scientific information accessible to research participants. ### Accountabilities - Conduct accurate pre-reviews of new and revised informed consent forms to assess compliance with applicable Food and Drug Administration (FDA), Department of Health and Human Services (HHS), Health Canada, Tri-Council Policy Statement 2 (TCPS 2), and International Council for Harmonisation Good Clinical Practice (ICH GCP) regulations and guidance. - Edit new and revised consent forms to ensure regulatory compliance, document accuracy, consistency, clarity, and alignment with established operational standards and procedures. - Apply negotiated sponsor and site language to consent form documents in accordance with client agreements and mandatory language documents. - Collaborate with Institutional Review Board (IRB) members and staff to incorporate required edits and ensure that input from relevant stakeholders is accurately reflected in final documents. - Perform informed consent quality-control reviews for your own work and the work of other editors to maintain high standards of accuracy, consistency, and compliance. - Mentor new team members and provide guidance on editing practices, regulatory requirements, consent documentation, and established workflows when requested. - Maintain and continuously expand knowledge of United States and/or Canadian regulations and guidelines related to human subject protections, drug research, device research, and cosmetic research. - Complete required Human Subjects Research training, including Collaborative Institutional Training Initiative (CITI) training, according to established management schedules. - Complete organizational training and other required professional development activities as assigned. - Attend at least one IRB meeting per month to strengthen understanding of IRB processes, with additional meetings during the initial training period. - Identify and communicate practical process-improvement opportunities to management to support greater efficiency, quality, and consistency. - Manage multiple editing assignments and competing priorities while maintaining accuracy, thoroughness, and established deadlines. - Work independently while following written and verbal instructions, established procedures, and regulatory requirements. - Perform other duties and projects as assigned by management. ### **Requirements** - Hold a bachelor's degree and have at least 2 years of experience in technical writing, medical writing, technical editing, medical editing, or a related field. - Have experience writing and/or editing informed consent forms or other research-related documentation. - Demonstrate proficiency with Microsoft Word processing and editing functions, including Track Changes and Compare/Merge capabilities. - Be familiar with Microsoft Excel, PowerPoint, direct messaging platforms such as Slack, remote meeting applications such as Zoom or RingCentral, and web-based proprietary software. - Bring at least 1 year of Institutional Review Board (IRB) experience, preferably within a clinical research or human subjects research environment. - Hold a Certified IRB Professional (CIP) certification or demonstrate willingness and eligibility to complete the certification within two years. - Demonstrate strong written and verbal English communication skills and the ability to communicate professionally with a diverse range of stakeholders. - Possess excellent interpersonal and customer service skills, with the ability to build effective professional relationships and collaborate constructively with colleagues and external stakeholders. - Have in-depth knowledge of human subjects research and informed consent principles, including the ability to interpret relevant regulatory and ethical requirements. - Be familiar with scientific and medical terminology and able to translate complex scientific or medical information into clear, understandable language appropriate for research participants. - Demonstrate strong technical and medical editing capabilities, including the ability to review advanced documents such as medical protocols and informed consent forms. - Be able to comprehend complex scientific, medical, and research documentation and accurately identify issues requiring clarification or correction. - Demonstrate excellent attention to detail, accuracy, thoroughness, and problem-solving skills. - Be capable of managing multiple editing projects simultaneously while balancing conflicting demands, priorities, and deadlines. - Consistently produce high-quality work and maintain strong standards of document accuracy and regulatory compliance. - Demonstrate the ability to work independently, exercise sound judgment, and follow established written and verbal instructions. - Possess strong focus, concentration, listening, comprehension, and verbal communication skills required to manage detailed technical work effectively. ### **Benefits** - Fully remote position available to candidates working within the United States. - Base salary range of **$66,767 to $116,089**, depending on location, skills, experience, and other relevant factors. - Potential eligibility for a variable bonus in addition to base salary. - Health coverage. - Paid holidays. - Additional employee benefits associated with the position. - Opportunity to contribute to ethical and compliant clinical research supporting the advancement of human health. - Opportunity to develop specialized expertise in informed consent, human subject protections, clinical research regulations, and Institutional Review Board processes. - Collaborative environment with opportunities to mentor colleagues and contribute to process improvements.