Clinical Research Associate II

Abbott • Alameda, CA

2d • $81,500 - $141,300 • Onsite

About The Position

The Clinical Research Associate II assists in the clinical execution and management of assigned clinical studies, including planning and implementing studies from concept through clinical study report while meeting timelines and quality standards. The position is based at Abbott’s Alameda, California office and involves conducting single- or multi-center medical device clinical studies, managing study sites and monitoring activities, and helping ensure studies comply with protocols, Good Clinical Practices, ICH guidelines, federal regulations, department procedures, and applicable regulatory requirements.

The role supports study start-up and conduct, including site visits, device and supply shipment and accountability, Trial Master File maintenance, clinical data review, and preparation of study documents and regulatory submissions. The CRA II works with senior staff and cross-functional teams, communicates study status to management, and helps deliver study activities within agreed budgets and timelines. The posting lists a base pay range of $81,500 to $141,300, which may vary by location.

Requirements

• Bachelor of Science degree in life sciences or equivalent.
• At least 5 years of clinical research experience.
• At least 2 years of relevant site-monitoring experience.
• Ability to travel; the role details list travel as 25% of the time, while the required qualifications state 30–50%.

Nice To Haves

• Experience conducting medical device and/or in-vitro diagnostics studies; pharmaceutical experience may also be considered.
• Demonstrated teamwork, a shared mindset for success, strong interpersonal and communication skills, and ability to build rapport with team members, peers, and management.
• Solid understanding and demonstrated experience with clinical trial processes, including study design and conduct, clinical data management systems, clinical trial management systems, data analysis, and data reporting and interpretation.
• Ability to solve problems with innovative solutions, along with strong project-management and organizational skills to deliver projects on time and on budget.
• Ability to manage numerous projects and conflicting priorities and adapt when priorities change.
• Working knowledge of GCP, Clinical Affairs, and Regulatory Affairs.
• Proficiency with Microsoft Suite.

Responsibilities

• Conduct single- or multi-center medical device clinical studies.
• Perform study site visits (SQV, SIV, IMV, and COV), prepare monitoring trip reports, and track action-item resolution.
• Participate in study start-up activities.
• Ship study devices and supplies to clinical sites and maintain study device accountability.
• Manage clinical monitoring and overall site management to ensure compliance with study protocols, GCPs, ICH guidelines, federal regulations, department procedures, and applicable regulatory requirements.
• Assist senior staff with study planning, case report form design, User Acceptance Testing, CRO selection and management, investigator-site selection and training, study meetings, investigator evaluation and training, and preparation of submissions.
• Maintain and audit the Trial Master File to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy and escalate issues to the Clinical Operations Manager as needed.
• Participate in cross-functional clinical teams to plan and execute clinical trials.
• Communicate clinical study status proactively and effectively to management.
• Ensure study deliverables are completed to quality standards within agreed budgets and timelines.
• Participate in interim and final study-data reviews in preparation for regulatory submissions.
• Help prepare applicable study documents, including the Trial Master File, clinical protocols, and reports.
• May work with Regulatory Affairs and Quality Assurance in responding to audits and FDA inquiries.

Benefits

• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, described as an affordable and convenient path to a bachelor’s degree.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level