Safety Clinical Research Associate (on-site)

Abbott • Maple Grove, MN

1d • $61,300 - $122,700 • Onsite

About The Position

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.

Requirements

• Bachelor’s 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.

Nice To Haves

• Bachelor's 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• Perform additional duties as assigned consistent with business needs and professional capabilities.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level