Centralized Study Spec I

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:

• Standard office environment.

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