Doc Review Specialist I - US Remote based

Fortrea•Durham, CA

1d•$55,000 - $65,000•Remote

About The Position

Joining Fortrea as a Document Review Specialist I today, 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 a full-time, remote exempt opportunity based in the US.

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).
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

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.