Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.
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.
Qualifications
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 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, ISO-14155, 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.
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.
