Clinical Research Associate Jobs

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.

Primary Function of Position:

The Clinical Research Associate 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 Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, 56, 11 and other applicable regulations as well as professionalism when interfacing with customers.

Roles & Responsibilities

• Organize (with assigned sites) IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful study procedures.
• Support all clinical research activities essential to the successful management of pre and post -market clinical studies under the direct supervision of the Manager of Clinical Affairs with a dotted line to the clinical study manager(s).
• Conduct clinical study monitoring (and co-monitoring, as assigned) to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan.
• Contribute to the preparation of study related documents (protocols, case report forms (CRFs), database validation, Informed consent forms (ICFs), Clinical trial agreements and budget negotiation, clinical monitoring plan), logs and forms used for the study activities,
• Maintain and track data of the assigned clinical study or studies including investigator selection start up and execution of study plan(s)and overall study status/progress throughout the life of a study.
• Track, process and manage site payments and support in study financial tracking by developing tracking tools as necessary.
• Manage site start-up and activation process, including:
• Drive review of safety events per policies and process guidance and collaborate on development of safety narratives and reporting.
• Support site audits and site audit preparation in anticipation of site inspections or internal audits. Follow up on audits, as directed.
• Assist Clinical Study Manager on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection
• Serve as main liaison to participating clinical trial sites with focus on site relationship, training, data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites.
• Develop format and manage study trial master file proactively and maintain study documentation and clinical trial management system, as assigned (e.g., correspondence, CRFs, study approval documents), monitoringreports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.), as directed.
• 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.
• Develop trackers with study team, as assigned.
• Collaborate with data management to support CRF build, amendment, and data cleaning process.
• Perform on-site (preferred) and remote (as needed) site qualification visits, site initiation visits, interim monitoring visits and close out visits.

Qualifications

Skills, Experience, Education, & Training:

• Prior experiences working in a clinical setting (industry/sponsor) is preferred
• Must be able to travel up to 50%
• Ability to multi-task and work in a dynamic environment with simultaneous projects/tasks
• Possess advanced knowledge Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations
• Clinical research/clinical trial management certification/education preferred
• Proficiency in Microsoft Office Suite, PDF application
• Must be clinically savvy and possess time management, organizational skills and problem-solving skills
• Minimum of 5 years of related experience with minimum BA/BS university degree; or 3 years’ experience monitoring clinical trials and a Nursing degree (preferred).
• Experience in medical device industry required
• Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary
• Excellent written and oral communication skills with internal and external partners, problem-solving skills and interpersonal skills with high attention to detail and organization

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.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Base Salary Range Region 1:$88,800 - $120,200

Base Salary Range Region 2: $75,500 - $102,100

Shift: Day

Travel: 50% of the time

Workplace Type: Remote - This job will be remote and/or the job is designed to be performed outside of the office. Employees will come onsite when requested by the leader.