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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.

• 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position of Sr. Clinical Research Associate works on-site at our Santa Clara, CA location in the Hematology Division. This role will support/lead clinical studies for one of the Alinity systems. Approximately 30% travel is required for this role, which may fluctuate depending on the phase of the study.

The Sr. CRA is responsible for designing, implementing, and monitoring clinical studies of new and modified invitro diagnostic products. They will ensure the clinical studies are designed to validate product performance claims and support the products’ intended use.

Prepares clinical data reviews and data summaries. Participates in the preparation of regulatory submissions and international registration packages. Manages a single large project, a more complex project, or several smaller related projects. The Sr CRA has established a high degree of competence in clinical research. The Sr CRA 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 Work On

• Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.

• Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies. Identifies and qualifies clinical investigators and clinical sites.

• Proposes and negotiates budgets for clinical sites.

• Ensures all essential documents are collected and completed according to procedures and applicable regulations.

• Conducts remote and on-site monitoring site visits and completes site visit reports.

• Monitors 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.

• Maintains accurate and timely sponsor/site correspondence and communication.

• Prepares Clinical Research reports and presents project progress reports to keep management and team informed.

• Responds to audits and data queries representing a project or team as required

• Assist in providing data for clinical sections of regulatory submissions and international registration packages.

• Assist in the preparation of responses to regulatory agencies’ questions regarding the clinical study.

• Additional responsibilities: Functions independently in the field and interacts with all levels of medical and scientific professionals.

• May advise and train newly hired CRAs and direct others in the completion of tasks and projects.

• Assumes responsibility for attending training sessions, presentations, and continuing education sessions to expand professional expertise

• Serves as a resource for technical questions or directs inquiries to appropriate references.

• Encourages collaborative behavior, delegates effectively, and empowers others to take action.

• Demonstrates good presentation skills (i.e., clear, concise, effective, and well-organized). Tries to understand changes in work tasks, situations, and environment as well as the logic or basis for change.

Required Qualifications

• Bachelor’s degree required.

• Knowledge of regulations and standards affecting GCP and IVDs or Biologics

• Minimum of 5 years clinical related experience, of which at least 2 clinical research monitoring with strong site management and monitoring skills. OR Minimum 5 years Laboratory experience with IVD’s, reviewing data and data analysis and applicable automated diagnostics and /or blood screening instruments and at least 1 year of clinical research monitoring experience

Preferred Qualifications

• Clinical Laboratory Certification MT(ASCP) or Certification as a CRA (CCRA) desirable.

• B.S. in biological science or medical specialty preferred.

• Excellent interpersonal and communication skills, including ability to build good rapport with clinical sites

• Organized, detail oriented, and excellent problem-solving skills with the ability to provide innovative solutions

• Experience with clinical systems (eTMF, CTMS, EDC, etc.)

• Ability to manage multiple projects with conflicting priorities and have the flexibility to adapt to changing priorities while working with a sense of urgency

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 ( http://www.abbottbenefits.com/pages/candidate.aspx ) 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. Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at http://www.facebook.com/Abbott and on Twitter @AbbottNews ( https://twitter.com/AbbottNews ).

The base pay for this position is $83,600.00 – $167,200.00. 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