Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team.
- Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
- 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 Covance ready for an audit at any time.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
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 0.5 – 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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