Clinical Research Associate; CRA

This is a remote position. We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities.

• 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.

• 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, 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.

In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well‑being. Our benefits include paid holidays, paid time off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work‑life balance while providing the necessary support for professional and personal growth.

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