Clinical Research Associate ll

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. JOB DESCRIPTION: The Opportunity: The CRA II will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. This role is located in Alameda, California. What you'll do: Conduct single or multi-center medical device clinical studies. Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items. Participate in study start up activities. Responsible for shipping study devices and supplies to clinical sites and performing study device accountability. Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Maintain and audit Trial Master File to ensure inspection readiness. Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed· Participate in cross-functional clinical team(s) in the planning and execution of clinical trials. Proactively and effectively communicate the status of clinical studies to management. Ensures quality delivery of study deliverables within agreed budgets and timelines. Participate in the interim and final reviews of study data in preparation of regulatory submissions. Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports). May interact with RA/QA in responding to audits and FDA inquiries. Perform other function-related activities in addition to the responsibilities as reasonably required by business needs. Qualifications: B.S. degree in life sciences or equivalent with minimum 5 years of clinical research experience Must have 2+ years of relevant experience in site monitoring. Experience in conducting medical device and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered. Skills Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management. Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation. Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget. Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change. Working knowledge of GCP, Clinical and Regulatory Affairs. Proficient with Microsoft Suite. Travel Requirements Must be able to travel 30-50% The base pay for this position is $79,500.00 $138,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Research and Discovery DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 1360-1380 South Loop Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter