Clinical Compliance Associate III
2 hours ago
Company Description
BioSpace, Inc. is a leading provider of innovative solutions for the life sciences industry. Our mission is to empower researchers, scientists, and clinicians to advance human health and well-being.
Job DescriptionWe are seeking a highly skilled Clinical Compliance Associate III to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and corporate policies.
Key Responsibilities:
- Perform quality control reviews of regulatory, scientific, and clinical documents
- Receive and complete tasks and assignments from scientific teams
- Lead project activities to ensure compliance with regulatory and corporate standards
- Identify issues that potentially impact study data, ethical study conduct, global regulatory, and AbbVie compliance
- Provide valuable quality control and compliance support for internal audits and regulatory authority inspections
Requirements:
- Bachelor's degree in a science-related field with +4 years of pharmaceutical/clinical research-related experience
- Associate degree/RN with 9+ years of experience in the pharmaceutical industry may be considered
- Good oral and written communication skills
- Knowledge of clinical study principles with experience supporting clinical research, drug development, and/or therapeutic area operations
- Ability to produce work of the highest quality by paying attention to detail
- Ability to appropriately and effectively use resources to complete tasks and meet required timelines
- Experience reviewing scientific data
- Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics, and Compliance)
Preferred experience with Cosmos, Vault, One-Vault.
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