Job Description

Title: Sr. Clinical Research Associate

Location: Sunnyvale, CA

Duration: 12+ Months

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.

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 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.

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 Master's 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 Client** 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.

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