The role involves managing document collection for studies, adapting patient materials to specific requirements, and supporting contract negotiations. Responsibilities include updating study documents, filing quality documents, and assisting in IRB submissions under supervision.
This is a remote position.
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements
- May support / assist the contract negotiation process under supervision of an experienced colleague or line manager
- Escalate study issues appropriately and in a timely fashion
- Update study documents when there are changes in study personnel/study amendments
- Contribute to the preparation of submissions to IRB/IEC with appropriate supervision
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making the company ready for an audit at any time
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision
Requirements
Experience
- 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)
- Minimum 0 - 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
- Demonstrated basic understanding of the clinical trial process
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