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Role Description

This role involves reviewing country and global project documents following the required guidelines.

• 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 Core Protocol for thoroughness and completeness and to assure compliance with Good Clinical Practice (GCP) guidelines.
• File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
• Draft Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight.
• Act as Document Review mentor on Informed Consent Form and Investigator Package as per mentoring plan for lower-level staff.
• 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.

Requirements

• Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
• 3 years’ work experience in clinical research.
• Training lower-level staff (Preferred).
• Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services).
• Excellent oral and written communication and presentation 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.

Benefits

• Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).