[Hiring] Document Review Specialist I @Fortrea

Role Description

Joining Fortrea as a Document Review Specialist I today will provide you with 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. The role includes:

• 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.

Qualifications

• 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.
• Strong knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines.
• 2 years’ work experience in clinical research.
• Training lower-level staff.

Requirements

• 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.
• 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.

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).