Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position :
The Clinical Research Associate 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 and Responsibilities :
Assist CAM / CAPM in protocol development, CRF designs and study documentation preparation for both pre-market and post market clinical studies.
Study 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 CPM 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 project manager in the 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.
Mentor Clinical Research Associates new to the position or company.
Support process improvement within clinical affairs
Required Knowledge, Skills, and Experience :
Bachelor’s degree in science / health care field or nursing degree
Experience working in medical device industry in the clinical affairs / research function with evidence of full monitoring responsibilities for at least three years.
Experience of monitoring responsibilities for pre-CE mark Euopean clinical studies is preferred.
Ability to manage multiple projects and varied tasks to meet deadlines.
English language required and a second European language (Dutch, French, or German preferred)
Ability and willingness to travel 70% of the time which may include several European countries.
Advanced knowledge of clinical research activities essential for both pre-market and post-market clinical studies.
Knowledge of applicable regulations (MDR, GCP, ISO-14155, MEDDEV guidelines, Data protection rules in EU).
Strong analytical and problem-solving skills, and flexibility to change.
Strong IT skills; including use of database programs for monitoring, analytics, and MS Office tools. e.g. Excel and PowerPoint
Excellent written and verbal communication and presentation skills.
Shift : Shift 1 - Day
Travel : No