In-House Cra I

Main Responsibilities
- 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 collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL
- To assist CRAs with preparation for site visits (i.e.
running reports, QC of files (checking for missing documents), resolving action items from previous visits)
- To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.
- To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by management
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