Clinical Research Associate
About The Position
Clinical Research Associate (CRA) Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Under supervision, the CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155. This is an on-site position in Alameda, California. This is not a remote position.
Requirements
- BS degree in life sciences required.
- 0-1 years of as a CRA/CRC/CTA experience, or combination of appropriate education and experience.
- Flexibility in daily activities or Perform any other duties as assigned by management.
- Proficient with Microsoft Suite
Nice To Haves
- Experience working on medical device studies and/or in-vitro diagnostics studies preferred.
- Pharmaceutical background may also be considered.
- Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs strongly preferred.
Responsibilities
- Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, and track resolution of action items.
- Assist and conduct clinical monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory 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 in development of study-specific forms and trial-specific monitoring plans.
- Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites.
- Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.
- Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed.
- Proactively and effectively communicate the status of clinical studies to management.
- Participate in the interim and final reviews of study data in preparation of regulatory submissions.
- May interact with RA/QA in responding to audits and FDA inquiries.
- Perform any other duties as assigned by management.
- Must be able to travel 30-40%-, with additional travel as required.
Benefits
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
