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Clinical Research Records Manager
2 months ago
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.
- 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.
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.