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Abbott · 11 hours ago

Senior Associate Clinical Quality

Des Plaines, IL

Full-time

Onsite

Mid, Senior Level

$75K/yr - $151K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Associate Clinical Quality will provide global support to Clinical Development staff, ensuring compliance with regulations and standards, and will play a key role in clinical study support and continuous improvement initiatives.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Provide global support to Clinical Development (CD) staff to ensure compliance with company policies, GCP regulations/guidelines, ISO standards, and other applicable requirements

Act as a reviewer of protocols, informed consent forms, case report forms and other essential study documentation for product and process changes, offer overall support to project teams in order to eliminate compliance risks; and Represents Clinical Quality at project / protocol deviation meetings to maintain and promote quality and compliance within CD

Advise CD staff on GCP guidelines, ISO standards, and departmental procedures

Facilitate departmental training sessions

Coordinate internal Continuous Improvement Detection (CID) and CAPA processes, including approval of proposed actions and follow-up until closure

Drive continuous improvement initiatives across CD

Review protocols, informed consent forms, case report forms, and other essential study documents for product and process changes

Provide compliance risk mitigation support to project teams

Represent Clinical Quality in project and protocol deviation meetings to promote quality and compliance

Assist project teams and investigational sites in preparing for AQR audits or regulatory authority inspections

Qualification

GCP regulationsISO standardsClinical researchQuality role experienceMedical devices experienceContinuous improvementTraining facilitationAudit support