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.
Responsible for implementing and maintaining the effectiveness of the quality system. The clinical research associate (CRA) 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. In general,the CRA performs responsibilities and task under the direction of a SCRA or CPM..
Implements and maintains the effectiveness of the Quality System.Complies with all policies,established procedures,and regulations related to clinical research. Actively participates as a member of the cross-functional project team.
With direction performs the following: - Assesses data generated by R&D/Business Teams. Prepares design validation plans. Prepares 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. Reviews data,prepares and presents clinical data reviews and data summaries. Responds to audits and data queries. Prepares the clinical sections of regulatory submissions and international registration packages.
Assists Regulatory in preparing responses to regulatory agencies' questions regarding 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.
Arranges for and assists in standard Statistical Support with the collection and statistical analyses of clinical data.
Monitors standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines,assures subject rights,safety,and welfare is protected,ensures data integrity through completeness,accuracy,and legibility.
Prepares and reviews product labeling and promotional materials.
Conducts standard pre-study,initiation,interim,and close-out monitoring site visits and completes site visit reports.,Initiates standard clinical studies and provides for investigator and staff training.
Maintains accurate and timely sponsor/site correspondence and communication.
Prepares and presents project progress reports to keep management and team informed.
Supports publication or presentation of clinical data in professional journals or meetings.
Maintains professional,product,and market expertise via independent reading,networking,and training.
Implements all policies,established procedures,and regulations into daily operations as appropriate.
Develops professional,expertise via professional and educational opportunities.
Assumes responsibility for attending training sessions,presentations,and continuing education sessions.
Works with assistance to prepare publications,abstracts,or presentations for professional meetings.
Contributes to goal setting.
Takes responsibility for achieving results.
Accepts and completes all management-directed work assignments such as clinical assignments,travel,and other tasks.
Demonstrates good basic writing skills. (i.e. clear,concise,effective,and well-organized) 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.
Participates in professional activities in the US and/or Internationally.
Minimum Bachelor's degree B.S in biological sciences or medical specialty preferred. Preferred knowledge of regulations and standards (GCP) affecting IVDs and Biologics.
Other: Clinical Laboratory certification (MT,ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable. Minimum of 3 years clinical related experience Preferred site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience.
JOB FAMILY:Medical & Scientific Affairs
LOCATION:United States > Lake Forest : CP01 Floor-3
TRAVEL:Yes, 25 % of the Time
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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