Primary Function of the Position
This role is does require the employee to be onsite in Sunnyvale CA based on business needs.
The Senior Clinical Research Associate will play a key role in proactively helping the conduct of premarket and postmarket 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 (premarket or postmarket 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 startup/activation process including: Heavy contribution to the preparation of studyrelated 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 followthrough 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 onsite and remote site qualification visits site initiation visits interim monitoring visits and site closeout 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 prestudy 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 :
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 Partand 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 crossfunctional teams
- Must be able to travel 2540% 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 selfeducate on different surgical specialties as applicable to clinical projects (Selfstarter 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 problemsolving 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.
Required Education and Training
- 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 Masters degree or an MD or PhD with a minimum 3 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.
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 COVID19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action 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.
EEO and AA Policy
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 marketcompetitive 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.
Remote Work :
No
Employment Type :
Fulltime