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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Originally posted on Himalayas