Clinical Records Supervisor, Business Operations
4 weeks ago
Facilitate the execution of clinical research trials at the AbbVie Clinical Pharmacology Research Unit (ACPRU) while adhering to all regulatory standards and AbbVie protocols, with a primary focus on records management.
This role encompasses overseeing Good Clinical Practice (GCP) documentation processes, which include coordinating study protocol evaluations, drafting informed consent documents, managing submissions to the Institutional Review Board (IRB), and ensuring the proper organization of essential documents (EDs) at the ACPRU.
Provide leadership and direction to team members, ensuring timely IRB approvals for study initiation. This position serves as the key liaison between the ACPRU, sponsor clinical teams, and the IRB.
Key Responsibilities:
- Oversee the maintenance of the ACPRU Records Room, which includes organizing files, ensuring document accountability, and managing offsite storage.
- Act as the ACPRU Records Coordinator, guaranteeing that clinical trial records are comprehensive and securely stored in designated areas.
- Collaborate with AbbVie Records Management to implement process changes that affect ACPRU operations.
- Supervise the preparation, collection, and submission of essential documents for clinical studies conducted at the ACPRU.
- Draft informed consent forms for internal review and submit them to the IRB, ensuring compliance with required language and documentation.
- Review protocol amendments and administrative changes to assess their impact on informed consent forms.
- Coordinate draft protocol reviews and consolidate feedback for the clinical team.
- Manage the submission of documents to the IRB, ensuring timely approvals for study commencement.
- Maintain professional communication with clinical teams and external stakeholders, including IRB representatives.
- Continuously evaluate records management activities for compliance with study protocols, departmental SOPs, and regulatory requirements.
- Develop corrective and preventive actions (CAPAs) as needed and implement process improvements for records management.
- Lead records management projects, including electronic systems, ensuring accountability for outcomes.
- Facilitate process review meetings and create process flows utilizing Lean Six Sigma methodologies.
- Generate performance metrics reports for the ACPRU.
- Demonstrate the ability to work independently and collaboratively, making informed decisions and providing guidance to staff.
This position requires a solid understanding of quality principles and research methodologies, as well as the ability to assess the implications of decisions made within the role.
Supervise a team of 0-4 non-exempt direct reports, providing mentorship and overseeing written communications.
Continuous standing for extended periods is a requirement of this role.
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