*** Position is located in Mexico City, Mexico ***
Ensure documents are filed and systems are updated on an ongoing and timely basis making
Covance ready for an audit at any time.
Collect and track regulatory & 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 support study
Follow up with sites in order to ensure documents required are collected in a timely manner.
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 site documents are filed in the TMF in a timely manner according to study
Undertake tasks delegated by senior team members, depending upon country and situational
requirements with proper supervision.
Perform other duties as assigned by management.
Recommended: University/College degree (life-science preferred), or certification in a related allied health profession from an appropiate accredited institution (e.g., nursing certification, medical or laboratory technology).
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
Demonstrated basic understanding of the clinical trial process, familiarized with EC-MoH submission packages and related processes. 1 Year of experience in start-up postions is preferred.