Job Description
Position’s Objective & Summary: The Clinical Research Associate (CRA) is a critical role principally performing remote on-site or in-house monitoring of clinical research studies data within his/her assigned projects in the region covered by Clinical Affairs. The candidate will ensure clinical trial conduct in compliance with applicable laws regulations MDD/MDR, ISO14155, guidance Good Clinical Practices (GCP), and Intuitive Surgical SOPs. This position will report to Clinical Affairs Europe, Intuitive Surgical Headquarters, in Switzerland. Roles & Responsibilities: • Assist Clinical Affairs Manager (CAM)/Clinical Affairs Project Manager (CAPM) in protocol development, CRF designs and study documentation preparation for both pre-market and post market clinical studies. • Monitoring responsibility for smaller studies. Conduct of on-site initiation visits, routine monitoring visits and closeout visits for both pre- and post-CE Mark studies. Remote clinical database monitoring and query follow up with the Investigational center(s) to address potential data discrepancies. Maintain study documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. Evaluation of the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Trouble-shoot with alignment of the CAPM any compliance issues at sites. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment, and enrollment, CRF completion and data query generation and resolution. Maintains site performance metrics and implements action plans for sites not meeting expectations. Assist in preparation and submission of regulatory packages to ethics committees and/or competent authorities. Support the CAM/CPAM in the management of the study such as development of monitoring tools, source document templates, CRF completion guidelines, Clinical Monitoring Plans. Develop additional study tools specific to the project or sites needs as required. Support EDC testing for newly implemented databases. Introduce Clinical Research Associates new to the position or company. Support process improvement within Clinical Affairs.
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Position’s Objective & Summary: The Clinical Research Associate (CRA) is a critical role principally performing remote on-site or in-house monitoring of clinical research studies data within his/her assigned projects in the region covered by Clinical Affairs. The candidate will ensure clinical trial conduct in compliance with applicable laws regulations MDD/MDR, ISO14155, guidance Good Clinical Practices (GCP), and Intuitive Surgical SOPs. This position will report to Clinical Affairs Europe, Intuitive Surgical Headquarters, in Switzerland. Roles & Responsibilities: • Assist Clinical Affairs Manager (CAM)/Clinical Affairs Project Manager (CAPM) in protocol development, CRF designs and study documentation preparation for both pre-market and post market clinical studies. • Monitoring responsibility for smaller studies. Conduct of on-site initiation visits, routine monitoring visits and closeout visits for both pre- and post-CE Mark studies. Remote clinical database monitoring and query follow up with the Investigational center(s) to address potential data discrepancies. Maintain study documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. Evaluation of the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Trouble-shoot with alignment of the CAPM any compliance issues at sites. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment, and enrollment, CRF completion and data query generation and resolution. Maintains site performance metrics and implements action plans for sites not meeting expectations. Assist in preparation and submission of regulatory packages to ethics committees and/or competent authorities. Support the CAM/CPAM in the management of the study such as development of monitoring tools, source document templates, CRF completion guidelines, Clinical Monitoring Plans. Develop additional study tools specific to the project or sites needs as required. Support EDC testing for newly implemented databases. Introduce Clinical Research Associates new to the position or company. Support process improvement within Clinical Affairs.
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