Editor I, Consent Form Development

Advarra•United States of America,

12d•$50,000 - $66,974•Remote

About The Position

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

Regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance.
Operational compliance with Advarra Standard Operating Procedures and Work Instructions.
U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections, drug research, device research, and cosmetic research.
Standard Human Subjects Research Training, such as CITI.
Organizational training as required by management.
Attend one IRB meeting per month.

Nice To Haves

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

Responsibilities

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).