Sr. Clinical Research Associate
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
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Our location in Lake Forest, Illinois currently has an opportunity for a Sr. Clinical Research Associate. This is an in-house role, incumbent must be onsite.
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. 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.
Main responsibilities include:
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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor Degree required. B.S. in biological science or medical specialty preferred.
Knowledge of regulations and standards affecting GCP, IVDs or Biologics required
Minimum of 5 years clinical related experience, of which at least 2 clinical research monitoring with strong site management and monitoring skills or minimum of 5 years laboratory experience with IVDs, reviewing data and data analysis and applicable automated diagnostics and/or blood screening instruments (e.g., ARCHITECT, PRISM).
Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)
Production areas that are clean, well-lit and temperature controlled (Include for Manufacturing roles only)
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.