Safety Clinical Research Associate (on-site)

About this role

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. • An excellent retirement savings plan with high employer contribution • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

Abbott Medical Devices, with revenue of $21B in 2025, is a global leader in providing life changing technology for the management and treatment of people living with chronic conditions including diabetes, cardiovascular disease, chronic pain, and movement disorders.

The Opportunity The Safety Clinical Research Associate (CRA) is responsible for supporting clinical safety and medical affairs activities through the collection, review, preparation, and management of clinical safety documentation and operational processes. The role provides critical support for safety committees, case narratives, source document management, translation coordination, and regulatory inspection readiness while ensuring compliance with applicable procedures and regulatory requirements. This new team member will work on-site at our Maple Grove, MN location.

What You’ll Work On Safety Documentation and Source Record Management • Collect, track, review, and manage source documentation associated with adverse events, serious adverse events, complaints, and clinical investigations. • Ensure source documents are complete, legible, and appropriately filed within designated safety systems and repositories. • Perform redaction of protected health information (PHI) and personally identifiable information (PII) in compliance with privacy and regulatory requirements. • Create, verify, and maintain bookmarked and inspection-ready PDF packages for regulatory submissions, audits, and committee reviews. • Maintain document inventories, tracking logs, and reconciliation records to ensure completeness and timely processing of safety documentation. • Coordinate retrieval of missing or outstanding records from study sites, investigators, vendors, and other stakeholders.

Clinical Event Committee (CEC) and Data Monitoring Committee (DMC) Support • Coordinate operational activities for Clinical Events Committees (CEC), Data Monitoring Committees (DMC), and other safety governance committees. • Schedule committee meetings and facilitate communication among committee members, investigators, and internal functional teams. • Prepare and distribute meeting agendas, briefing packages, committee dossiers, and supporting documentation. • Manage committee document workflows, including redaction, quality review, version control, and archival activities. • Track committee actions, recommendations, decisions, and deliverables and ensure timely follow-up. • Support preparation of data listings, safety summaries, and endpoint review documentation for committee evaluations.

Narrative Development and Medical Writing Support • Draft and maintain adverse event, serious adverse event, complaint, and endpoint adjudication narratives using available clinical and source documentation. • Ensure narratives are medically accurate, consistent, complete, and compliant with company procedures and applicable regulatory expectations. • Collaborate with Clinical Safety Physicians, Medical Directors, and Safety Specialists to resolve data queries and narrative discrepancies. • Support preparation and quality review of clinical safety reports and supplemental safety documentation.

Translation and Vendor Coordination • Coordinate translation requests for safety-related source documents, medical records, narratives, and committee materials. • Liaise with approved translation vendors to ensure timely delivery and quality of translated documents. • Review translated content for consistency, completeness, and alignment with source documentation. • Maintain translation tracking logs and associated documentation.

Clinical Safety Operations Support • Support safety case processing activities through document acquisition, reconciliation, and quality control. • Participate in safety data review activities and assist in identifying incomplete or inconsistent documentation. • Contribute to inspection readiness efforts by ensuring documentation is organized, traceable, and audit-ready. • Assist in development and maintenance of standard operating procedures, work instructions, templates, and tracking tools. • Collaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, Quality, and external vendors. • Maintain compliance with Good Clinical Practice (GCP), applicable regulations, privacy requirements, and company policies.

Responsibilities for All Functions • This job description is intended to describe the general nature and level of work performed by individuals assigned to this position and is not intended to be an exhaustive list of responsibilities. • Perform additional duties as assigned consistent with

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