Abbott Senior Clinical Research Associate - Hematology in Santa Clara, California
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 109,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT DIAGNOSTICS:
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 109,000 colleagues serve people in more than 160 countries.
WHAT YOU’LL DO
Responsible for implementing and maintaining the effectiveness of the quality system. The senior clinical research associate (SCRA) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products. Ensures that 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 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.
Actively participates as a member of the cross-functional project team. - Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study. - 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.
Serves as a consultant in a select area of expertise., Clinical monitoring responsibilities include: -
Prepares design validation plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.
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 studies.
Initiates payments to sites.
Obtains and reviews all required essential documents necessary for study initiation.
Initiates clinical studies and provides for investigator and staff training.
Arranges for and assists Statistical Support with the collection and statistical analyses of clinical data.
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.
Conducts pre-study, initiation ,interim, and close-out monitoring site visits and completes site visit reports.
Maintains accurate and timely sponsor/site correspondence and communication.
Responsibilities for preparing Clinical Research reports/presentations include: - Prepares and presents project progress reports to keep management and team informed.
Reviews data, prepares and presents clinical data reviews and data summaries.
Responds to audits and data queries representing a project or team.
Prepares standard the clinical sections of regulatory submissions and international registration packages.
Prepares and reviews product labeling and promotional materials.
Coordinates preparation of responses to regulatory agencies’ questions regarding the clinical study.
Assists in presentation of clinical information to the FDA.
Initiates standard publication or presentation of clinical data in professional journals or meetings.
Prepares publications, abstracts, or presentations for professional meetings with minimal assistance.
Additional responsibilities: - Functions independently in the field and interacts with all levels of medical and scientific professionals.
May advises and trains newly hired CRAs and direct others in the completion of tasks and projects.
Maintains professional, product, and market expertise via independent reading, networking, and training.
Assumes responsibility for attending training sessions, presentations, and continuing education sessions to expand professional expertise via professional and educational opportunities.
Serves as a resource person for most technical questions or directs inquiries to appropriate references.
Volunteers for task forces, manages projects, or serves as a group leader.
Encourages collaborative behavior, delegates effectively, and empowers others to take action.
Gives effective feedback.
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.
Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups.
Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
Accountable for the project scope and scheduled completion date.
Works under general management direction.
Participates in professional activities in the US and/or Internationally.
EDUCATION AND EXPERIENCE, YOU’LL BRING
Bachelor’s degree required. B.S. in biological science or medical specialty preferred. Other: Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable.
Knowledge of regulations and standards affecting GCP and IVDs required.
Minimum of 5 years clinical related experience, of which at least 2 clinical IVD research monitoring with strong site management and monitoring skills.
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 (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) .
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 firstname.lastname@example.org