Editor II, Consent Form Development

Advarra•United States of America,

1d•$54,029 - $89,148•Remote

About The Position

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.

Requirements

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 RingCentral, and web-based proprietary software

Nice To Haves

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
Knowledge of matters regarding human subjects research and informed consent
Familiar with scientific/medical terminology and able to convert scientific/medical information to lay terms
Ability to edit technical and/or medical documents
Ability to read and comprehend advanced technical/medical documents such as medical protocols and informed consent forms
Ability to manage various editing projects under conflicting demands and priorities
Dependably produces high quality work
Must have high level of attention to detail, accuracy and thoroughness; 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 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