Associate I Clinical Research

Abbott • Alameda, CA

11d • Onsite

About The Position

The Associate I Clinical Research role 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 may include other function-related activities assigned by management. Travel is required; the posting states both 30–50% travel with additional travel as needed and 25% of the time in the travel field.

The role supports clinical monitoring, site management, study start-up, study-device logistics and accountability, trial documentation, data review, and preparation for regulatory submissions. It may also involve responding to audits and FDA inquiries in coordination with Regulatory Affairs and Quality Assurance.

Requirements

• Bachelor of Science degree in life sciences, or equivalent, with at least one year of clinical research experience; an appropriate combination of education and experience may also qualify.
• Working knowledge of the Code of Federal Regulations (CFR), ICH-GCP, Clinical Affairs, and Regulatory Affairs.
• Proficiency with Microsoft Suite.
• Teamwork, interpersonal, and communication skills, including the ability to build rapport with team members, peers, study-site staff, and management.
• Flexibility in daily activities.
• Ability to travel as required.

Nice To Haves

• Experience working on medical-device studies and/or in-vitro diagnostics studies.
• A pharmaceutical background may also be considered.
• Life sciences bachelor’s degree is preferred.

Responsibilities

• Perform study site visits (SQV, SIV, IMV, and COV), prepare monitoring reports, and track resolution of action items.
• Assist with and conduct clinical monitoring and site management activities, ensuring 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, case report form (CRF) design, 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 reviews of study data in preparation for regulatory submissions.
• May interact with Regulatory Affairs and Quality Assurance when responding to audits and FDA inquiries.
• Perform other duties as assigned by management.
• Travel 30–50%, with additional travel as required; the posting also lists travel at 25% of the time.

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, described as an affordable and convenient path to a bachelor’s degree.

What This Job Offers

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