Description
We are seeking a Document Review Specialist II to review Informed Consent Forms and Advertisements following project and country-specific regulations as well as ICH-GCP, FDA and other regional guidance.
Responsibilities:
- Review Country/Site Informed Consent Form to ensure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Review Patient Recruiting materials (Advertisements) to ensure 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 protocol amendment to reconfirm completeness and ensure 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.
Qualifications:
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- 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:
- 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.