Doc Review Specialist I - US Remote based
Doc Review Specialist I – US Joining Fortrea as a Document Review Specialist I today and you will have a rewarding career, a chance to work in an energetic & team-oriented workplace and exposure within a world-leading team. The Document Review Specialist I role is responsible for reviewing Investigator Packages, Informed Consent Forms and Advertisements following project & country specific regulations as well as ICH-GCP, FDA and other regional guidance. Document Review Specialist I is responsible for reviewing revised protocols & core ICF’s. This is full time, remote exempt opportunity based in US. Key / Core Responsibilities
- Review Initial/Amended Investigator Packages to assure compliance with regulatory
- requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial.
- Review Core/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.
- Review Investigator Package Plans that document the required quality of documents
- included in Investigator Packages following the available SOP with manager oversight.
- 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.
Required Qualifications
Education:
- 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).
- Fluent in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience:
- Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
- 2 years’ work experience in clinical research Training Lower-level staff
Work Environment
Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Pay Range: USD $55,000-$65,000 Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO). Application Deadline: June 2, 2026 #remote #LI-SE1 Learn more about our EEO & Accommodations request here.