Associate I Clinical Research

Abbott • Alameda, CA

1d • $73,900 - $116,000 • Onsite

About The Position

The Associate I Clinical Research (CRA) ensures the quality, accuracy, and integrity of clinical trial data throughout the lifecycle of multiple clinical trials, in accordance with the Code of Federal Regulations, ICH GCP, and ISO 14155. This is an on-site position in Alameda, California, and is not remote. The role requires travel; the posting states both that travel may be 30–50% with additional travel as required and that travel is 25% of the time.

The CRA supports clinical study start-up, monitoring, site management, data review, trial documentation, and preparation for regulatory submissions. The role works with study sites and internal clinical operations staff, and may interact with Regulatory Affairs and Quality Assurance in response to audits and FDA inquiries. Other function-related duties may be assigned by management.

Requirements

• A bachelor's degree in life sciences or equivalent, with at least one year of clinical research experience, or an appropriate combination of education and experience.
• Ability to travel; the description states travel may be 30–50%, with additional travel as required, and separately lists travel as 25% of the time.
• Demonstrated teamwork and interpersonal and communication skills, including the ability to build rapport with study site staff, team members, peers, and clinical management.
• Working knowledge of CFR, ICH-GCP, and Clinical and Regulatory Affairs.
• Proficiency with Microsoft Suite.

Nice To Haves

• Experience working on medical device studies and/or in-vitro diagnostics studies; pharmaceutical experience may also be considered.
• Flexibility in daily activities.

Responsibilities

• Perform study site visits, including SQV, SIV, IMV, and COV visits; generate monitoring reports and track resolution of action items.
• Assist with and conduct clinical monitoring and site management activities to ensure compliance with the study protocol, GCP, ICH guidelines, federal regulations, department procedures, and other applicable requirements.
• Participate in study start-up activities.
• Assist with shipping study devices and supplies to clinical sites.
• Perform study device accountability and reconciliation.
• Assist senior staff with developing study-specific forms and trial-specific monitoring plans.
• Assist senior staff with study planning, designing case report forms (CRFs), and training study sites.
• Maintain and audit the Trial Master File (TMF), and upload documents to the eTMF to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager or Study Lead as needed.
• Communicate clinical study status proactively and effectively to management.
• Participate in interim and final study data reviews in preparation for regulatory submissions.
• May interact with Regulatory Affairs and Quality Assurance in responding to audits and FDA inquiries.
• Perform other duties as assigned by management.

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, providing an affordable and convenient path to a bachelor's degree.

What This Job Offers

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