Sr. Clinical Research Associate

Intuitive Surgical•Sunnyvale, CA

35d

About The Position

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 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.

Requirements

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 travel 25-40% or based on business requirements
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 manage CRAs and CTAs and 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.
Typically requires a minimum of 8 years of related experience with a BA/BS university degree; or a minimum 6 years' experience and a Nursing degree, a Master's degree, or an MD or PhD with a minimum 3 years' experience; or equivalent experience in a scientific field.

Nice To Haves

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.

Responsibilities

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.