Clinical Research Associate Job at Abbott | Apply Now
A rare chance to join Abbott as a Clinical Research Associate I in Alameda, California. This Clinical Research Associate job offers an opportunity to contribute to clinical trials and ensure the integrity of clinical data in a leading global healthcare organization.
- Position: Clinical Research Associate I
- Location: Alameda, California, United States
- Category: Research & Development
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. The organization’s portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Abbott employs approximately 122,000 colleagues who serve people in more than 160 countries.
Clinical Research Associate Job Description
This Clinical Research job requires the Clinical Research Associate I to 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 ISO 14155.
Required Qualifications
Required Qualifications for Clinical Research Associate job include:
- BS degree in life sciences preferred with minimum 0-1 year CRA/CRC/CTA experience; or a combination of some education and minimum 2 years of experience will be considered.
- Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred. A pharmaceutical background may also be considered.
- Demonstrate excellence in teamwork, solid interpersonal and communication skills including building rapport with team members/peers, study site staff, and clinical management.
- Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs.
- Flexibility in daily activities.
- Proficient with Microsoft Suite.</li>
Clinical Research Associate job – Key Responsibilities
- Perform internal clinical studies, recruit study participants, conduct informed consent discussions with study volunteers, record study data, and maintain study files.
- Coordinate internal clinical studies from start to close-out.
- 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 with 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 the 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 the 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 for regulatory submissions.
- May interact with RA/QA in responding to audits and FDA inquiries.
Salary: The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.
This Clinical Research Associate job at Abbott presents an excellent opportunity for qualified candidates to contribute to impactful clinical research. Interested individuals are encouraged to apply before the deadline to seize this opportunity for professional growth and development.
