About this role
This is a remote position seeking experienced Clinical Research Associates (CRAs) for surge capacity support on ongoing clinical research projects. The role focuses on study maintenance and closeout activities to ensure efficient project execution. CRAs serve as primary points of contact for study teams and external partners, without study startup involvement.
Oversee study-level project management tasks including study maintenance, data lock, closeout, document review, and budget monitoring. 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.
Act as the primary liaison between internal study teams and external third-party organizations (TPOs). Collaborate with internal teams to align clinical research processes and operational strategies. Coordinate with business partners and TPOs to facilitate data delivery and compliance with study requirements.
Join a dynamic and collaborative work environment. Benefit from a comprehensive package including paid holidays and Paid Time Off (PTO) policy. Support employee well-being with medical insurance.
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
- Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, 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
Benefits
- Dynamic and collaborative work environment
- Paid holidays
- Paid Time Off (PTO) policy
- Medical insurance
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