Clinical Research Associate
United StatesContractMiddle
Salary not disclosed
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Job Details
- Experience
- 6+ years of experience in clinical research or a related industry
- Required Skills
- Project ManagementGCPMicrosoft Excel
Requirements
- Bachelor’s degree in a relevant field.
- 6+ years of experience in clinical research or a related industry.
- Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant.
- 3+ years of experience in project management or a related role.
- Prior experience in pharmaceutical, diagnostics, or CRO environments.
- Strong organizational skills with attention to detail.
- Ability to effectively communicate with diverse stakeholders.
- Proficiency in Microsoft Excel for data tracking and reporting.
- Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, OracleInForm, or similar platforms.
- Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases.
- Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements.
Responsibilities
- Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring.
- Act as the primary liaison between internal study teams and external third-party organizations (TPOs).
- Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data.
- Manage and track clinical queries to ensure timely resolution.
- Collaborate with internal teams to align clinical research processes and operational strategies.
- Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements.
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