Fortrea
ICF Reviewer II
Romania · Remote (restrictions not stated) · Full time
Apply on the employer’s site ↗See how well you match this job
You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.
About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerFortrea
- LocationRomania
- Work styleRemote (restrictions not stated)
- Employment typeFull time
- Employer posted
Job Overview:
Document Review Specialist I is responsible for reviewing Informed Consent Forms and Advertisements following project and country specific regulations as well as ICH-GCP, FDA and other regional guidance. Document Review Specialist I may responsible for reviewing revised protocols and core ICF’s.
Summary of Responsibilities:
- Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
- Review protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines.
- Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review.
- And all other duties as needed or assigned.
Show full description
Qualifications (Minimum Required):
- 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)
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
Experience (Minimum Required):
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
- 2 years’ work experience in clinical research
- Previous interaction with operational project teams preferred.
Preferred Qualifications Include:
- Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services)
- Good written and oral communication skills
- Well-developed organizational skills
- Excellent proof-reading skills
- Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects
- Ability to work independently within a flexible team environment
- Accuracy and Attention to detail
- Analytical and problem-solving skills
Physical Demands/Work Environment:
- Standard office environment.
Learn more about our EEO & Accommodations request here.
Check your resume against this job Free, no sign-up. Nothing you paste is stored.
Staying safe while you apply
- Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
- Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
- Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.
Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.
Preparing for this role with ROLIVA
- Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
- Prepare honestly.
Build interview stories and application drafts from your own evidence.
- Keep track.
Save the role and record your own application status and follow-ups.
At a glance
- Work styleRemote (restrictions not stated)
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked
Skills in this posting
Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.