Clinical Research Associate I

Job description

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 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Clinical Research Associate I Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. 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’ll Work On The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as assigned by management. 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. 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. Preferred Qualifications 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 Perform any other duties as assigned by management. Preferred Qualifications Demonstrated excellence in teamwork, stellar interpersonal and communication skills including building rapport with team members, peers, and management. Working knowledge of GCP, Clinical and Regulatory Affairs. Flexibility in daily activities. Proficient with Microsoft Suite Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. CRM As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Vascular Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. Neuromodulation Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Structural Heart Structural Heart Business Mission: Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and ma