Clinical Research Operations Director

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Chronicle Bio is a data-driven healthcare platform building the world’s most comprehensive biobank and multi-omic data resource for chronic conditions, starting with neuroimmune diseases. We work at the intersection of clinical research, biospecimen science, and AI to unlock transformative insights for precision medicine.

Overview

The Clinical Research Operations Director will oversee and coordinate operations across our multi-site Clinical Research enterprise. This role is responsible for ensuring compliance with all regulatory requirements, supporting the strategic growth of our research infrastructure, managing research and administrative staff, and together with the Clinical Trial Business Development Director, oversee budgets and financial performance. This position plays a critical role in advancing the organization’s mission to conduct high-quality, compliant, and innovative clinical research.

Key Responsibilities

Compliance & Regulatory Oversight

• Ensure adherence to federal, state, and local regulations (FDA, OHRP, GCP, HIPAA, IRB, CLIA, etc.).
• Maintain and monitor standard operating procedures (SOPs) across all sites.
• Partner with clinical investigators and regulatory affairs to ensure timely protocol approvals, reporting, and audits.
• Oversee research contracts, sub-investigator agreements, and compliance-related documentation across all sites.

Staff & Site Management

Strategic Leadership & Growth

Cross-Functional Collaboration

Qualifications

Education & Experience :

Key Attributes

Details

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