Clinical Research Records Manager
4 weeks ago
Purpose: We are seeking a highly skilled Clinical Research Records Manager to support the conduct of clinical research trials at the AbbVie Clinical Pharmacology Research Unit (ACPRU). As a key member of our team, you will be responsible for managing records management activities, ensuring compliance with regulatory requirements, and providing guidance to direct reports.
Key Responsibilities:
- Manage the GCP 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 creation, collection, maintenance, and submission of essential documents for clinical studies conducted at the ACPRU.
- Act as the liaison between the ACPRU and the sponsor clinical teams, as well as between the ACPRU and the IRB.
- Ensure Institutional Review Board (IRB) approvals are received on time for study start-up.
- 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 required with relevant work experience.
- 5 years of 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 of experience using Windows-based word processing, spreadsheet, presentation, graph, and table software, with database experience preferred.
- 2 years of familiarity with CAPA process.
- 5 years of familiarity with medical terminology or regulatory documents.
- 5 years of proven ability to work in a team atmosphere.
What We Offer:
- A comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
- Opportunities for professional growth and development.
- A collaborative and dynamic work environment.
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