1 day ago Be among the first 25 applicants

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

• Supervise and mentor site-level Clinical Research Managers and Coordinators, nurses, and support staff.
• Standardize processes, training, and performance management across all sites.
• Foster a culture of accountability, teamwork, and continuous improvement.
• Support recruitment and retention of clinical research staff across all sites.
• Develop and manage budgets for clinical research operations across sites.
• Deploy and enforce compliance with the CTMS platform across sites and coordinators.
• Manage biobank operations across all sites including onboarding with ChronicleBio team and ensure compliance and quality around biospecimen management.
• Monitor financial performance, including grant/contract billing, site budgets, and cost recovery.
• Coordinate vendor and CRO relationships; oversee purchasing of equipment, supplies, and services.
• Ensure effective resource allocation across all sites, balancing workload, staffing, and timelines.

Strategic Leadership & Growth

• Collaborate with executive leadership to expand the clinical research enterprise nationally.
• Contribute to strategic planning, new site onboarding, and process integration.
• Implement standardized systems for data capture, reporting, and operational efficiency.
• Serve as a liaison between investigators, external partners, and leadership.

Cross-Functional Collaboration

• Partner closely with the Clinical Trial Business Development Director to operationalize new trial opportunities, ensuring rapid site activation, staffing readiness, and protocol compliance.
• Provide operational input during trial feasibility and budget negotiations to align site capacity with business development goals.

Qualifications

Education & Experience:

• Bachelor’s degree in life sciences, healthcare administration, or related field required; Master’s degree preferred.
• Minimum 7+ years of progressive experience in clinical research operations, preferably in an academic, healthcare, or multi-site research environment.
• Demonstrated knowledge of clinical research regulations, compliance standards, and best practices.
• Experience managing teams, budgets, and cross-functional operations.
• Strong leadership, staff development, and interpersonal skills.
• Excellent organizational and project management abilities.
• Financial acumen with ability to manage budgets and contracts.
• Proficiency with research management systems, CTMS, EHR integration, and related platforms.
• Ability to thrive in a fast-paced, entrepreneurial environment with distributed teams.

Key Attributes

• Mission-driven, with a passion for advancing clinical research to benefit patients.
• Strategic thinker with strong operational execution.
• Collaborative, adaptable, and able to balance detail with big-picture vision.
• Position will start off remote and move to in-person early 2026

Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Management and Manufacturing

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.