Records Manager, Business Operations (On-Site, IL Based)

$80,500 - $153,000/Yr

AbbVie - North Chicago, IL

Full-time - Mid Level

North Chicago, IL

Chemical Manufacturing

About the position

The Records Manager in Business Operations at AbbVie is responsible for overseeing records management at the AbbVie Clinical Pharmacology Research Unit (ACPRU). This role involves ensuring compliance with regulatory requirements, managing essential documents for clinical trials, and acting as a liaison between various teams. The position requires strong organizational skills, attention to detail, and the ability to lead projects and teams effectively.

Responsibilities

• Support the conduct of clinical research trials by managing records at the ACPRU.
• Supervise maintenance of the ACPRU Records Room, including document filing and accountability.
• Manage the creation, collection, maintenance, and submission of essential documents for clinical studies.
• Draft informed consent forms and submit them to the IRB, ensuring compliance with required language and documentation.
• Review protocol amendments and ensure necessary revisions are made to informed consent forms.
• Act as a liaison between ACPRU and clinical teams regarding protocol edits and submissions.
• Prepare and submit documents to the IRB, ensuring timely approvals for study start-up.
• Continually assess records management activities for compliance with protocols and regulations.
• Lead records management projects and implement process improvements.
• Facilitate process review meetings and generate performance metrics reports.

Requirements

• Bachelor's degree preferred or Associate's degree with relevant work experience.
• 5 years of experience in a medical environment or healthcare organization.
• 5 years of familiarity with clinical research or quality assurance.
• 2 years of experience with word processing, spreadsheet, and presentation software.
• 2 years of familiarity with the CAPA process.
• 5 years of familiarity with medical terminology or regulatory documents.
• Proven ability to work in a team atmosphere.
• Knowledge of records management and strong organizational skills.

Nice-to-haves

• Experience with database management.
• Familiarity with Lean Six Sigma (LSS) principles.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical, dental, and vision insurance
• 401(k) plan
• Short-term incentive programs