Job Description

2 days ago Be among the first 25 applicants Lensa is the leading career site for job seekers at every stage of their career. Our client, Abbott, is seeking professionals in Alameda, CA. Apply via Lensa today! 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, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. The Opportunity 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. What You Will Do 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 30-50%-, with additional travel as required. Qualifications BS degree in life sciences preferred or equivalent with minimum one (1) year of clinical research experience, or combination of appropriate education and experience. Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered. Perform any other duties as assigned by management. 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 Proficient with Microsoft Suite The base pay for this position is $72,100.00 – $114,700.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Lensa by 2x Get notified about new Clinical Research Associate jobs in Alameda, CA . Alameda, CA $72,100.00-$114,700.00 6 days ago Alameda, CA $72,100.00-$114,700.00 6 days ago San Francisco, CA $70,000.00-$110,000.00 6 days ago Foster City, CA $106,000.00-$123,000.00 4 days ago Alameda, CA $72,100.00-$114,700.00 2 weeks ago Alameda, CA $72,100.00-$114,700.00 2 weeks ago Hayward, CA $80,000.00-$95,000.00 2 weeks ago San Francisco, CA $42.08-$63.13 2 weeks ago Clinical Trial Assistant I, Clinical Operations San Mateo County, CA $40.00-$45.00 5 days ago Clinical Trial Assistant I, Clinical Operations Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate) Clinical Trial Research Coord I- Walnut Creek Alameda, CA $79,500.00-$138,700.00 2 weeks ago Preclinical Discovery Research Associate Clinical Research Associate (6-Month Contract) Part-Time Assistant Clinical Research Coordinator Assistant Clinical Research Coordinator - Breast Oncology San Francisco, CA $42.08-$63.13 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Lensa

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