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 103,000 colleagues serve people in more than 160 countries.
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Santa Clara, CA currently has an opportunity for a Sr. Clinical Research Associate.
Design, implement, and monitor clinical studies of new and modified in vitro diagnostic products. Ensure that the clinical studies are designed to validate product performance claims and support the products’ intended use. Prepare clinical data reviews and data summaries. Participate in the preparation of regulatory submissions and international registration packages. Manage a single large project, a more complex project, or several smaller related projects. The SCRA has established a high degree of competence in clinical research. The SCRA has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research.
WHAT YOU’LL DO
- Actively participates as a member of the cross-functional project team.
- Participate in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study.
- Clinical monitoring; Prepare design validation plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions. Prepare clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies. Identify and qualify clinical investigators and clinical sites.
- Budgeting for clinical studies.
- Monitor clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare are protected, ensures data integrity through completeness, accuracy, and legibility.
- Conduct pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports.
- Prepare and Clinical Research Presentations.
- Assist in presentation of clinical information to the FDA.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Minimum Bachelor Degree required. B.S. in biological science or medical specialty preferred.
- Knowledge of regulations and standards affecting GCP and IVDs
- 5 years clinical related experience, of which at least 2 clinical IVD research monitoring with strong site management and monitoring skills.
- Clinical Laboratory Certification MT(ASCP) or CRA (CCRA)
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- 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
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
JOB FAMILY:Medical & Scientific Affairs
LOCATION:United States > Santa Clara : 4551 Great America Parkway
TRAVEL:Yes, 25 % 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 standing 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), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis
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