Intuitive Surgical Careers

Clinical Research Associate - Germany

Germany
Clinical Affairs


Job Description

Job: Clinical Affairs
Primary Location: Germany
Schedule: Full-time
Requisition ID: 190365

Description

Position’s Objective & Summary:
  • The Clinical Research Associate is a critical role principally performing remote and on-site monitoring of clinical research studies data within his/her assigned projects in the region covered by Clinical Affairs. This role will support projects primarily in Germany.
Roles & Responsibilities:
  • Assist CAM/CAPM in protocol and CRF designs and study documentation preparation.
  • For small projects may have responsibility for these activities
  • Conduct 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 appropriate 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. 
  • 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. 
  • 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
  • Support EDC testing for newly implemented databases.
  • Mentor Clinical Research Associates new to the position or company
Qualifications

Required Knowledge, Skills, and Experience:
  • Bachelor’s degree in science/health care field or nursing degree
  • Minimum of 3 years Clinical Research Associate experience
  • German native language and fluent in English
  • Ability and willingness to travel 50% to 70% of the time, primarily via plane or train
  • Advanced knowledge of clinical research activities essential for pre- post market clinical studies
  • Knowledge of applicable regulations (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 eg Excel and PowerPoint
  • Ability to manage multiple and varied tasks to meet deadlines
  • Excellent written and verbal communication and presentation skills
Preferred Knowledge, Skills, and Experience:
  • Experience in the medical device industry
  • Experience working with surgeons