Clinical Research Associate

The Clinical Research Associate (CRA) is a critical role principally performing remote onsite or inhouse 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.

Responsibilities:

• Assist Clinical Affairs Manager (CAM) / Clinical Affairs Project Manager (CAPM) in protocol development, CRF designs, and study documentation preparation for both premarket and post market clinical studies.
• Monitoring responsibility for smaller studies.
• Conduct of onsite 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.
• Troubleshoot 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.
• Maintain site performance metrics and implement 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, and Clinical Monitoring Plans.
• Develop additional study tools specific to the project or site's 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.

Qualifications:

Required Knowledge, Skills, and Experience:

• Bachelor's degree in science/health care field or nursing degree.
• Experience working in the 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 European clinical studies is preferred.
• Ability to manage multiple projects and varied tasks to meet deadlines.
• English language required and a second European language preferred (French or German).
• Ability and willingness to travel up to 25% of the time, which may include several European countries.
• Advanced knowledge of clinical research activities essential for both pre CE and post CE mark clinical studies.
• Knowledge of applicable regulations (MDR, GCP, ISO14155, MEDDEV guidelines, GDPR, and applicable local regulations).
• Strong analytical and problem-solving skills and flexibility to change.
• Strong IT skills, including use of eCRF and CTMS for monitoring analytics and MS Office tools.
• Excellent written, verbal communication, and presentation skills.

Additional Information:

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information, or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.