Doc Review Specialist I - US Remote based

Join Fortrea as a Document Review Specialist I and you will have a rewarding career, a chance to work in an energetic & team-oriented workplace, and exposure within a world-leading team. This is a full-time, remote exempt opportunity based in the US.

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 Forms 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 amendments 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.
• All other duties as needed or assigned.

Requirements

• 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.
• Fluent in English, both written and verbal.
• Strong knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines.
• 1 year of work experience in clinical research.

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

USD $60,000-$70,000

Benefits

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)