Abbott Clinical Research Associate in Des Plaines, Illinois
At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Function / Primary Goals / Objectives:
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 conducted per established policies, procedures, regulations, and Good Clinical Practice (GCP). Participates in the preparation of regulatory submissions and international registration packages
Responsible for implementing and maintaining the effectiveness of the quality system.
Complies with all policies, established procedures, and regulations related to clinical research.
Attends 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.
Participates in the design validation process 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.
Assists with budgets for clinical studies and initiates payments to clinical sites.
Obtains and reviews all required essential documents necessary for study initiation.
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.
Responds to audits and data queries.
Prepares project progress reports to keep management and team informed.
Assist with clinical sections of regulatory submissions and international registration packages.
Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
May perform other duties as assigned.
B.A. or B.S. in the biological sciences is desirable, but will consider 5 to 6 years of experience in the clinical research environment
Other: Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable.
This position requires an understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and scientific, statistical, regulatory, and compliance requirements for conducting clinical research.
Minimum of 4 years’ relevant professional experience including:
Laboratory (hospital, research, industrial) 3 to 4 years
Clinical Research 1 to 2 years
Quality Assurance/Auditing 1 to 2 years
Diagnostic Customer Contact 1 to 2 years
Other: This position requires good oral and written communication skills, familiarity with desktop computer office software, ability to travel (50-80% US and/or international), and participation in professional activities outside of normal business hours.
Accountability / Scope:
Describe the primary accountabilities of the position and the impact of actions.
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. Works under the direction of the Clinical Project Manager.
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