Clinical Research Associate III
Intuitive

Job Info

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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 Position:

The Clinical Research Associate- III will report to Manager, Clinical Affairs, and will play a key role to proactively support the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.

Roles & Responsibilities:

• Support all clinical research activities essential to the successful management of clinical studies under the direct supervision of clinical affairs manager with dotted lines to clinical study manager.
• Maintain and track data of the clinical studies including investigator selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study.
• Manage site start-up/activation process, including: heavy contribution to the preparation of study related documents (protocols, case report forms/eCRFs, draft informed consent forms and complete checklists, able to support in clinical trial agreements and budget negotiation, clinical monitoring plan), organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.
• Amends clinical study documents as needed and support clinical sites with institutional review board submission as necessary.
• Perform site qualification visits, site initiation visits, interim monitoring visits and site close out visits
• Collaborate with data management to ensure data cleaning process is performed and perform source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a paper case report form at sites to ensure regulatory and protocol compliance and overall accuracy.
• Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall accuracy via both on-site and remote monitoring in accordance with the study monitoring plan.
• Serve as main liaison to participating clinical trial sites with focus on data entry, query resolution, and study conduct oversight at the participating clinical sites.
• Provide project administrative support including maintenance of study documentation (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
• Track, process and manage site payments and support in study financial tracking.
• Assist clinical project managers/clinical study manager on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection
• Perform site audits in preparation for site inspections
• Maintain trial master file essential documents and clinical trial management system

Qualifications

Skills, Experience, Education, & Training:

• Possess advanced knowledge of Good Clinical Practice and 21 CFR Part 11, 50, 54, 812 and international regulations
• Minimum Bachelor's degree in scientific field required
• Minimum 5 years of experience in clinical trial operations and monitoring preferred
• Clinical research/clinical trial management certification/education preferred
• Must be clinically savvy and possess time management, organizational skills and problem-solving, oral presentation skills.
• Excellent written and oral communication skills, problem-solving skills and interpersonal skills with high attention to detail and organization
• Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary.
• Proficiency in Microsoft Office, including Word, PowerPoint, Visio and Excel
• Experience working with electronic data capture systems required and preferred experience in clinical trial management systems
• Experience in medical device industry required
• Must be able to travel up to 30%
• Ability to multi-task and work in a dynamic environment with simultaneous projects/tasks

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

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.

Shift : Day

Travel : 25% of the time

Travel Requirements:25% of the time Shift:Day

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