Clinical Research Associate II

Abbott • Alameda, CA

1d • Onsite

About The Position

The Clinical Research Associate II assists with the clinical execution and management of assigned clinical studies, including planning and implementation from concept through clinical study report in accordance with timelines and quality standards. The role is based in Abbott’s Alameda, California office and involves conducting medical device clinical studies, managing clinical monitoring and study sites, maintaining study documentation, and supporting regulatory submissions and audits. Travel is required.

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 description states 30–50% in the qualifications and 25% in the travel field.
• Strong teamwork, interpersonal, and communication skills, including the 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.
• Demonstrated problem-solving ability and strong project-management and organizational skills to deliver projects on time and on budget.
• Ability to manage multiple projects and conflicting priorities and adapt when priorities change.
• Working knowledge of GCP, Clinical Affairs, and Regulatory Affairs.
• Proficiency with Microsoft Suite.

Nice To Haves

• Experience conducting medical device and/or in-vitro diagnostics studies is preferred.
• Pharmaceutical background may also be considered.

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 activities and overall site management to ensure compliance with study protocols, GCP, 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, and preparation and assembly of submissions.
• Maintain and audit the Trial Master File to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy, escalating issues to the Clinical Operations Manager as needed.
• Participate in cross-functional clinical teams to plan and execute clinical trials.
• Communicate clinical study status to management.
• Deliver study outputs within agreed budgets and timelines while meeting quality expectations.
• Participate in interim and final study-data reviews in preparation for regulatory submissions.
• Prepare applicable study-conduct 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

• Career development opportunities with an international company.
• Employees may qualify 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, offering an affordable and convenient path to a bachelor’s degree.

What This Job Offers

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