Editor I, Consent Form Development

Advarra

Supports the IRB Services department in preparing informed consent forms (ICFs) for human subject research. Conducts regulatory compliance reviews and collaborates with Board members and staff.

Posted 6/16/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $50,000 - $66,974 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs)
Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions
Editing new and revised consent forms to ensure regulatory compliance and alignment with Advarra document standards
Applying negotiated Sponsor language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s
Collaborating with Board members and staff to include all necessary edits to the consent form from the various stakeholders
Keeping up to date with U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections, drug research, device research, and cosmetic research
Completing standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
Completing organizational training as required by management
Attending one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period)

Requirements

What you’ll need

2+ years of experience in technical, medical writing and/or editing
Associates degree

Benefits

Comp & perks

Health coverage
Paid holidays
Variable bonus

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

technical writingeditingregulatory complianceinformed consent formsFDA regulationsHHS regulationsHealth Canada regulationsICH GCP guidanceAdvarra Standard Operating ProceduresHuman Subjects Research Training

Soft Skills

collaborationattention to detailcommunicationorganizational skills

Certifications

CITI certification