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Clinical Research Records Manager

2 months ago


North Chicago, Illinois, United States AbbVie Full time
Job Summary

We are seeking a highly skilled Clinical Research Records Manager to join our team at AbbVie. As a key member of our Clinical Pharmacology Research Unit (ACPRU), you will be responsible for managing clinical research trials in accordance with regulatory and AbbVie requirements.

Key Responsibilities
  • Manage clinical site documentation activities, including facilitating study protocol reviews, drafting informed consent forms, and coordinating and submitting IRB and sponsor trial master files.
  • Supervise the maintenance of the ACPRU Records Room, including creating charts, filing documents, and record accountability.
  • Manage the creation, collection, maintenance, and submission of essential documents for clinical studies conducted at the ACPRU.
  • Prepare and submit documents to the IRB, and oversee the submission of documents to the IRB.
  • Continually assess ACPRU records management activities for compliance with study protocols, departmental SOPs, and ICH GCP and FDA regulations.
Requirements
  • Bachelor's degree preferred or Associate's degree with relevant work experience.
  • 5 years' experience in a medical environment or healthcare organization, with familiarity with clinical research or quality assurance and AbbVie quality assurance, clinical research, or R&D systems.
  • 2 years' experience with using Windows-based word processing, spreadsheet, presentation, graph, and table software, with database experience preferred.
  • Possess knowledge of records management, excellent attention to detail, and strong organizational skills to meet timelines and work on multiple projects simultaneously.
What We Offer

AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.