Safety CRA — Medical Writing & Regulatory Support

Abbott; Maple Grove (MN); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Maple Grove, MN is seeking a Safety Clinical Research Associate to support clinical safety and medical affairs activities. You will manage source documentation, safety narratives, translation coordination, and committee support to ensure compliance with regulatory requirements.

This on-site role will contribute to safety governance and data integrity. You will collaborate with Clinical Safety Physicians, Medical Directors, and cross-functional teams to prepare data listings, safety

Qualifications

• Bachelor’s degree required.
• 2 years of related experience; 1 year in conducting clinical research.
• Experience with clinical safety documentation and regulatory submissions preferred.
• Strong written communication and narrative writing skills.

Responsibilities

• Collect, track, review, and manage source documentation for adverse events and investigations.
• Coordinate safety committees and prepare agendas and dossiers.
• Draft and maintain adverse event narratives.
• Coordinate translation requests and liaise with translation vendors.
• Support inspection readiness and development of SOPs and tracking tools.
• Maintain compliance with GCP and privacy requirements.

Skills

Document management

Narrative writing

Attention to detail

Communication skills

Education

Bachelor's degree (Life Sciences / Nursing / Pharmacy)

Clinical Research Certification (CCRA, CPI)

Tools

PDF redaction

Electronic document management systems

Job description

Abbott in Maple Grove, MN is seeking a Safety Clinical Research Associate to support clinical safety and medical affairs activities. You will manage source documentation, safety narratives, translation coordination, and committee support to ensure compliance with regulatory requirements.

This on-site role will contribute to safety governance and data integrity. You will collaborate with Clinical Safety Physicians, Medical Directors, and cross-functional teams to prepare data listings, safety