Senior Clinical Research Associate

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 a pioneer and market leader in 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

Primary Function of the Position

The Senior Clinical Research Associate will play a vital role in supporting pre-market clinical studies of investigational drugs for the Fluorescence Imaging group, ensuring full compliance with regulatory requirements. The ideal candidate will have in-depth knowledge of clinical research in oncology, including Good Clinical Practice (GCP) and relevant US regulations for human subjects.

As a member of the Clinical Fluorescence Imaging team, this individual will collaborate with key stakeholders and contribute to the successful execution of pre-market clinical studies, working independently with minimal supervision. The role will involve close coordination with Senior Clinical Project Managers, the Head of the Fluorescence Imaging Clinical Team, and other team members.

The Sr CRA will also travel frequently to Investigational Sites to conduct co-monitoring along with the assigned Field CRA(s)/Monitor(s) assigned to specific investigational sites by the CRO.

Essential Job Duties

• Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval.

• Maintain and track clinical study data monitored and help in Investigator, Sub-Investigators qualification and selection, training, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study.

• Co-Management of site start-up/activation process, including heavy contribution to the preparation of study-related documents and complete checklists, able to help with clinical trial agreements and budget negotiation, finalization of clinical monitoring plan, training materials, etc.

• Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs.

• Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes.

• Assist with amendments clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submission if necessary.

• Experienced with performing on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO.

• Conduct clinical study co-monitoring to ensure regulatory and protocol compliance and overall data accuracy in accordance with the study clinical monitoring plan.

• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy.

• Assist and support participating clinical trial sites, to ensure timely data entry, data integrity, query resolution, investigational drug accountability, and study conduct oversight at the participating clinical sites.

• Partner with data management (CRO) to help the data cleaning process.

• Assist with the development and management of study electronic clinical trial master file (eTMF) and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports