At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Senior Clinical Research Associate needed in Des Plaines, IL
Easily commutable from Chicago or suburbs. Opportunity to work on new Device development utilizing cutting edge technology. This division works on Diagnostic testing - screening for viruses. Competitive salary, annual bonus, benefits including medical, dental, 401k, pension, etc
Primary Function / Primary Goals / Objectives:
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 conducted per established policies, procedures, regulations, and Good Clinical Practice (GCP). Participates in the preparation of regulatory submissions and international registration packages. Works with minimal supervision on a single large project, a complex project, or several smaller projects. Has established a high degree of competence in clinical research. 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.
Responsible for implementing and maintaining 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.
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.
Prepares clinical 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 clinical sites.
Initiates payments to clinical sites.
Obtains and reviews all required essential documents necessary for study initiation.
Collaborates with 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 closeout monitoring site visits and completes site visit reports.
Maintains accurate and timely sponsor/site correspondence and communication.
Reviews data, prepares, and presents clinical data reviews and data summaries.
Responds to audits and data queries.
Prepares and presents project progress reports to keep management and team informed.
Prepares the clinical sections of regulatory submissions and international registration packages.
Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
Maintains professional, product, and market expertise via independent reading, networking, and training.
Functions independently in the field and interacts with all levels of medical and scientific professionals.
Advises and supports newly hired CRAs with department procedures.
Suggests improvements for increased departmental efficiency.
May perform other duties as assigned.
Preferred candidate will have strong background in the Lab or as a Medical Tech as well as Field monitoring experience as a CRA.
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 the direction of the Clinical Project Manager.