Sr Editor, Consent Form Development

Advarra•United States of America,

6d•$66,767 - $116,089•Remote

About The Position

The Sr Editor, Consent Form Development supports Advarra’s IRB Services department by reviewing incoming submissions and preparing informed consent forms (ICFs) for human subjects research. The role also includes mentoring new editors and completing projects assigned by management. The position is open to candidates working remotely in the United States.

Requirements

At least 2 years of experience in technical or medical writing and/or editing, in addition to a bachelor’s degree.
Experience writing and/or editing consent forms or other research documents.
Proficiency with word-processing and editing, including Track Changes and Compare Merge functions.
Familiarity with Excel, PowerPoint, direct-messaging applications such as Slack, remote-meeting applications such as Zoom or RingCentral, and web-based proprietary software.

Nice To Haves

At least 1 year of IRB experience.
Certified IRB Professional (CIP), or completion of CIP within two years of eligibility.
Clear and professional verbal and written communication skills in English.
Excellent interpersonal skills and the ability to work professionally and effectively with others while providing high levels of customer service.
In-depth knowledge of human subjects research and informed consent.
Familiarity with scientific and medical terminology and the ability to convert scientific or medical information into lay terms.
Ability to edit technical and/or medical documents.
Ability to read and comprehend advanced technical and medical documents, such as medical protocols and informed consent forms.
Ability to manage multiple editing projects with conflicting demands and priorities.
Dependable production of high-quality work.
High attention to detail, accuracy, and thoroughness, along with problem-solving skills.
Ability to follow written and verbal instructions and work independently as required.

Responsibilities

Conduct accurate pre-reviews of new and revised consent forms for compliance with applicable FDA, HHS, Health Canada, and TCPS2 regulations; ICH GCP guidance; and Advarra Standard Operating Procedures and Work Instructions.
Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards.
Apply negotiated sponsor and site language to consent forms as required by client agreements and mandatory language documents (MLDs).
Collaborate with Board members and staff to incorporate necessary stakeholder edits into consent forms.
Perform informed consent quality-control checks on own work and the work of others.
Mentor new team members as requested.
Maintain and increase regulatory knowledge relevant to organizational compliance, including U.S. and/or Canadian regulations and guidelines concerning human subject protections, drug research, device research, and cosmetic research.
Complete recurring Human Subjects Research Training, such as CITI, on a cycle determined by management.
Complete organizational training as required by management.
Attend one IRB meeting per month to enhance understanding of IRB processes, or two meetings per month during the initial training period.
Offer process-improvement suggestions to management, as applicable.
Perform other duties as assigned.