Clinical Research Associate I

Responsibilities

• Ensure the quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials.
• Coordinate internal clinical studies from start to close-out, including performing study site visits (SQV, SIV, IMV, COV).
• Conduct clinical monitoring and site management activities to ensure compliance with Study Protocols, GCP, ICH guidelines, and Federal Regulations.
• Perform study device accountability and reconciliation, and assist with shipping study devices and supplies to sites.
• Maintain and audit the Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
• Review clinical data listings for completeness and accuracy, escalating issues to management as needed.
• Assist senior staff in the development of study-specific forms, monitoring plans, and case report forms (CRFs).

Requirements

• BS degree in life sciences preferred (or equivalent combination of education and experience).
• Minimum 2 years of experience as a CRA, CRC, or CTA.
• Working knowledge of CFR, ICH-GCP, and Clinical/Regulatory Affairs.
• Proficiency with the Microsoft Office Suite.
• Strong interpersonal and communication skills with the ability to build rapport with team members and site staff.

Preferred Qualifications

• Experience in conducting medical device or in-vitro diagnostics (IVD) studies.
• Background in pharmaceutical clinical research.

Benefits

• Career development opportunities within an international healthcare leader.
• Health Investment Plan (HIP) PPO medical coverage options.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement and student debt assistance programs.
• Access to FreeU education benefits for obtaining a bachelor's degree.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and branded generic medicines. With over 115,000 colleagues serving people in more than 160 countries, we are dedicated to advancing innovative technologies that improve global health.