Clinical Research Associate
Intuitive
Amsterdam, North Holland, Netherlands
1 dag geleden

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

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