Clinical Research Associate 2

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:

The Clinical Research Associate will play a key role in providing operational support to coordinate the conduct and data management of clinical studies to ensure compliance with Intuitive Fluorescence Imaging LLC, standard operating procedures, Good Clinical Practices (GCP), good documentation practices, and applicable regulations.

The ideal candidate will have good understanding of clinical trials regulatory requirements.

Roles and Responsibilities:

• Collaborate with internal stakeholders and key opinion leaders (KOLs) to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives.
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (protocols, case report forms, informed consents, clinical trial agreements, monitoring plan), organizing Institutional Review Board (IRB) / Ethics Committee (EC) submissions with follow thorough to ensure successful outcome.
• Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
• Interact with external vendors and sites to negotiate contracts and budgets.
• Track study progress and provide status report on a weekly basis with internal team and vendors.
• Participate in data analysis, interpretation and synthesis, instruction in order to develop clinical study reports and /or support development of scientific publications.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., 21 CFR Part 312, GCP and US and OUS guidelines).
• Conduct literature reviews to stay abreast of scientific knowledge and to determine evidence gaps.
• Collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities.
• Author and assist in the development of preclinical and clinical documents including protocols and amendments, Investigator’s Brochures, IRB applications, informed consent forms, statistical analysis plans (SAP), clinical monitoring plans (CMP), Investigational New Drug (IND) Submissions, annual reports and clinical study reports.
• Design and assist in the development, review and pre-validation of case report forms (CRFs), electronic data capture strategies (EDC with eCRFs), and clinical study databases.
• Establish, organize, and maintain trial master file and clinical trial management system to ensure regulatory and protocol compliance including maintenance of study essential documentation (e.g., correspondence, CRFs, study approval documents, curriculum vita), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget).
• Support payment and budget tracking of clinical sites and vendors.
• Prepare and ship site binders and patient binders as necessary.
• Responsible for data trial data management and working with documentation specialist to archive and store clinical trial data.
• Coordinate and manages ordering, shipping, labeling and tracking of study supplies (including investigational products) 

Qualifications

Skill/Job Requieremen