REF17582I Clinical Research Associate

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.