Clinical Research Associate 3

Job description

Primary Function of Position The Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have a thorough knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, and other applicable regulations. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies (pre-market or post-market studies) with minimal supervision. The candidate will be required to work closely with clinical study managers, clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, contribute to clinical study reports, or help the development of clinical publications. The candidate is also expected to have experience reviewing, interpreting, and summarizing clinical literature. Essential Job Duties Contribute to all clinical research activities to ensure the successful management of clinical studies. Maintain and track clinical study data and help in investigator qualification and selection, scrutiny 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 (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, able to help 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 (ICF, CRFs, Monitoring Plan, etc…) as needed and helps clinical sites with institutional review board submission as necessary. Perform on-site and/or remote site qualification visits, site initiation visits, interim monitoring visits, and site close-out visits. Conduct clinical study 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. Serve as the main liaison to participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites. Partner with data management to help the data cleaning process. Drive review of safety events and partner on developing narrative and reporting as needed. Develop and manage study trial master file and maintain study documentation and clinical trial management system (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 help in study financial tracking by developing tracking tools as necessary. Assist the Clinical Study Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection. Help site audits and site audit preparation in anticipation of site inspections. Qualifications Required Skills and Experience Previous experience implementing, helping and managing medical device trials. Significant knowledge of clinical and/or outcomes research study design Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements Clinical research/clinical trial management certification/education preferred Prior experiences working in a clinical setting is preferred Excellent ability to interact with physicians and other professionals inside and outside the company. Excellent experience in protocol and ICF development, writing clinical section(s) for regulatory submission. Experience negotiating clinical research contracts and budgets. Must be able to work effectively on cross-functional teams Must be able to manage multiple projects and/or manage different priorities Excellent communication, presentation and relational skills with high attention to detail and organization Ability to learn quickly, adjust to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”). Ability to support management with relevant study updates. Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset. Proficiency in Microsoft Office Suite, PDF application. Experience working with electronic data capture (EDC) systems required. Experience in clinical trial management systems preferred. Experience in medical device industry required. Experience running clinical trials focused on COPD required. Required Education and Training Typically requires a minimum of 6 years of related experience with a BA/BS university degree; or a minimum 4 years’ experience and a Nursing degree, a Master’s degree, or an MD or PhD with a minimum 1 years’ experience; or equivalent experience in a scientific field. Preferred Skills and Experience Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred. Knowledge of statistics, statistical methods, and design of experiment is highly preferred 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 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. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 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. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. 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 compensation ranges are listed. It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here.