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 requiredfor effective and compliant study site activation and maintenance
Ensure that all assigned maintenance and Start-up activities are on track and in accordance withclient expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
Serve as primary contact for investigative sites and ensure documents required are collected ina timely manner.
With guidance from line manager and experienced colleagues, adapt Informed Consent Formsand other patient facing material to country specific requirements.
May support / assist the contract negotiation process under supervision of an experiencedcolleague 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.
Perform other duties as assigned by management.
Level of education preferred (if required or experience level which may be substituted for level of education).
Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
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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