Clinical Study ICF Writer

Fortrea

Doc Review Senior Specialist providing oversight of regulatory documents for global projects. Collaborating with teams to ensure compliance and mentor junior staff in the process.

Posted 5/28/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $90,000 - $110,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and/or review initial/amended Core Informed Consent Forms (ICFs)
Review Core/Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks
Support system compliance and system data entry, as applicable
File required task-related documentation in the Electronic Trial Master File (eTMF)
Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines
Act as Document Review mentor for lower-level staff and help train lower-level staff on Document Review processes and expectations
Oversee Local Investigator Package reviewers work for a specific country
Serve on SOP Review Team(s) as expert in Document Review processes and expectations
Serve as a Subject Matter Expert for partnership processes on Document Review activities such as Informed Consent Form
And all other duties as needed or assigned

Requirements

What you’ll need

University/College degree (life science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
Expert knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines
5 years' work experience in clinical research

Benefits

Comp & perks

Medical
Dental
Vision
Life
STD/LTD
401(K)
Paid time off (PTO) or Flexible time off (FTO)
Company bonus where applicable

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Informed Consent Forms (ICFs) developmentDocument Review processessystem compliancedata entryElectronic Trial Master File (eTMF)study-specific plansGood Clinical Practice (GCP)regulatory compliancetask-related documentationmentoring

Soft Skills

communicationliaisingtrainingoversightcollaborationproblem-solvingattention to detailtime managementleadershipteamwork

Certifications

University/College degreenursing certificationmedical technology certificationlaboratory technology certification