Sr. Clinical Research Associate

Job Description

Primary Function of the Position

The Senior 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 partand 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 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.
• Mentor junior CRAs and CTAs on monitoring and other study needs.

Qualifications : Qualifications

Required Skills and Experience

Required Education and Training

Preferred Skills and Experience

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 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 employeeswho 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 governments 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 employeesstart 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.

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.

Remote Work : No

Employment Type : Full-time

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Experience : years

Vacancy : 1