We count on you to:

CRA - all levels 

• General On-Site Monitoring Responsibilities, including routine monitoring visits and close-out of clinical sites;
• Conduct pre-study visits such as SQV – Site Qualification Visit and SIV – Site Initiation Visits;
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) by carefully reviewing source documents;
• Perform CRF review, including generating and resolving queries, to ensure data quality;
• Maintain study files, ensuring audit readiness at the site level;
• Prepare and provide FUP (Follow-Up) letters and reports within the established deadlines for respective monitoring visits;
• Track and follow up on Serious Adverse Event (SAE) reporting, including producing reports, narratives, and following up on SAEs;
• Track and follow up on Deviation Reports according to the study's plan;
• Act as the focal point of communication between the site team, project manager, and vendors to resolve any arising issues. Liaise with vendors and perform other duties as assigned;
• Ensure that the conduct of clinical trial activities complies with current ethical regulations, Good Clinical Practices, and protocol guidelines;
• Maintain accounting and control of investigational products and other trial materials/supplies;
• Travel, including air travel, will be required and is an essential function of the job. Prepare accurate and timely trip reports and expense reimbursements.

Lead CRA:

• Train, develop and assist Monitoring Team (CRA all levels) and Clinical Research Analysts.
• Identify and evaluate issues in the management of activities of research site, through monitor follow-up and propose resolutions and action plans for the team.
• Support the review of project-related plans, such as monitoring, deviation, risk plans and study specific documents.
• Perform revision of monitoring reports such as site qualification reports (SQV), initiation (SIV), regular monitoring (MoV) and close-out (CoV) reports, ensuring their quality and follow-up on outstanding items and issues.
• Perform sampling review of the eTMF to ensure its quality.
• Develop and support CRAs and analysts, seek process and tool optimization to form high-performance teams.
• Act as the main communication liaison between CRAs, Clinical Project Managers and Clinical Operations Managers.
• Ensure that clinical monitoring activities of the assigned team are conducted to sponsor satisfaction, ensuring quality results in a timely manner, within budget, and in accordance with standard operating procedures (SOPs), local regulations, good clinical practices (GCP), and study-specific requirements.
• Supervise the performance of monitors and analysts, as well as develop performance evaluation metrics and necessary training.
• May be required to provide on-site supervision for CRAs and/or conduct monitoring or co-monitoring (as needed).
• Oversee and maintain study-specific and corporate trackers.
• Supervise CRAs workload and propose adjustments and reallocations of human resources.