Editor II, Consent Form Development

Remote - U.S.A
United States of America, 000000, USA

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

The Editor II, Consent Form Development supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subject research.

• Conduct accurate pre-reviews of new and revised consent forms to ensure regulatory compliance with FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and Advarra Standard Operating Procedures and Work Instructions
• Edit new and revised consent forms to align with regulatory standards and Advarra document requirements
• Incorporate negotiated Sponsor language into consent form documents as outlined in client agreements
• Collaborate with Board members and staff to incorporate necessary edits from various stakeholders into consent forms
• Maintain and enhance knowledge of U.S. and/or Canadian Regulations and Guidelines related to Human Subject Protections, drug research, device research, and cosmetic research
• Complete standard Human Subjects Research Training, such as CITI, on a recurring cycle determined by management
• Fulfill organizational training requirements as directed by management
• Attend at least one IRB meeting per month to enhance understanding of IRB processes (two meetings per month during initial training period)
• Offer suggestions for process improvements to management as appropriate
  Other duties as assigned

This role is open to candidates working remotely in the United States.

• 1+ years of experience in technical/medical writing and/or editing in addition to a Bachelor’s degree
• Experience writing and/or editing consent forms or other research documents
• Proficiency in Word processing and editing (including use of Tracked Changes and Compare Merge functions)
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom or Ring Central, and web-based proprietary software

• Some clinical research experience
• Experience writing and/or editing consent forms or other research documents
• Experience writing and/or editing consent forms or other research documents
• Ability to communicate clearly and professional in English, both verbal and written skills
• Strong interpersonal skills to work professionally and effectively with others and provide high levels of customer service
• Knowled…