Job Overview:
Document Review Specialist I is responsible for reviewing Investigator Packages, 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 is responsible for reviewing revised protocols and core ICF’s.
Summary of 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 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 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 (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:
