The Study Monitor/CRA conduct monitoring visits for assigned trial protocol and trial sites. Overall responsibilities are to ensure that the trial is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Performs site monitoring throughout the trial which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work.
- Performs quality functions and executing quality programs (clinical operations, clinical laboratory) as per GCP/GCLP and regulations
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- Setting up the trial sites such that each center has the trial materials, including the trial drug while ensuring all trial supplies are accounted for
- Administers protocol and related trial training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- May provide training and assistance to junior clinical staff.
- Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required trial documentation.
- Manages the progress of assigned studies by tracking regulatory/IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
- Verifying that data entered on to the CRFs is consistent with participant clinical notes (source data/document verification)
- Writing visit reports.
- Filing and collating trial documentation and reports.
- Archiving trial documentation and correspondence.
- Evaluates the quality and integrity of trial site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalates quality issues to the Quality Manager, Project Manager and/or senior management.
- Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required.
Age: 35 Years