Safety Clinical Research Associate (on-site)

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. Youll 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 bachelors 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 Youll 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 business needs and professional capabilities.

Required Qualifications:

• Bachelors degree
• 2 years of related experience; or equivalent combination of education and work experience
• 1 year of experience in conducting clinical research or related scientific laboratory skills.

Preferred Qualifications:

• Bachelors degree in Life Sciences Nursing Pharmacy Health Sciences Clinical Research or related field.
• Clinical Research Certification (e.g. CCRA CCRC CPI). Medical Technology (e.g. MLT/MT CLS)
• 2-5 years of experience in Clinical Research Clinical Safety Pharmacovigilance Medical Affairs or related healthcare environment.
• Experience supporting adjudication committees safety review boards or clinical trial operations preferred.
• Experience handling medical records source documentation and regulated clinical documents
• Knowledge of clinical research processes and Good Clinical Practice (GCP).
• Understanding of safety reporting and medical terminology.
• Strong document management quality review and organizational skills.
• Experience with PDF redaction bookmarking and document preparation tools.
• Strong written communication and narrative writing skills.
• Ability to coordinate multiple stakeholders and manage competing priorities.
• Proficiency with Microsoft Office applications and electronic document management systems.
• Attention to detail with demonstrated ability to maintain accuracy and confidentiality.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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