Editor I, Consent Form Development

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Advarra

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1983

☁️ SaaS

🤖 Artificial Intelligence

Healthcare • SaaS • Artificial Intelligence

Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.

📋 Description

• 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

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

🏖️ Benefits

• Health coverage • Paid holidays • Variable bonus