Abbott · 2 months ago
Clinical Research Associate I
United States - California - Alameda
Full-time
Onsite
Entry Level
$74K/yr - $116K/yr
1+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Clinical Research Associate I will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials, while participating in study site visits and compliance activities.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
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 30-50%-, with additional travel as required
Qualification
Required
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
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
Benefits
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.
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
Company data provided by crunchbase