- To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
- To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA
- To assist CRA with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items form previous visits).
- To perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
- To assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.
- To proactively work with sites and projection teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
- To liaise with the CTA to assist the Project Team in the production of Status Reports.
- General On-Site Monitoring Responsibilities per the monitoring plan.
- To facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
- To undertake other project related administrative tasks (i.e. recruitment tracking, site document preparation) as appropriate, as assigned by the Project Manager and CTL.
- University degree (life science preferred), or certification in a related allied heath profession from an appropriately
- Basic understanding of biology and biological processes
- Good organizational and time management skills
- Good communication skills, oral and written
- Exhibit general computer literacy
- Works efficiently and effectively in a matrix environment
- Fluent in local official language and in English, both written and verbal.