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Abbott · 21 hours ago

Senior Clinical Research Associate - C

Des Plaines, IL

Contract

Onsite

Senior Level

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Clinical Research Associate (CRA) supports the Companion Diagnostic (CDx) clinical team by managing and executing Phase I–IV clinical studies in compliance with Federal Regulations, ICH guidelines, and study protocols.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Manage and monitor Phase I–IV CDx clinical studies in accordance with regulatory requirements and study protocols

Plan and support overall study conduct, including timelines, milestones, and deliverables

Contribute to the development and review of clinical study protocols and related documents

Design and review case report forms (CRFs)

Support selection, training, and management of CROs and external vendors

Assist with selection, training, and oversight of study investigators and clinical sites

Plan, organize, and participate in investigator meetings and study-related meetings

Support evaluation and onboarding of new study investigators

Assist with study budget development and contract negotiations with CROs and study sites

Contribute to the preparation, review, and supervision of clinical study reports and regulatory documents, including NDA components such as ISS and ISE, as applicable

Ensure accurate documentation and compliance with internal procedures and regulatory standards

Support cross-functional collaboration with internal stakeholders

Qualification

Clinical research experienceICH-GCPRegulatory complianceCROsMicrosoft Office proficiencyOrganizational skillsCommunication skillsProblem-solving skills