Clinical Trials Site Lead — Regulatory & Operations

PRCCI; San Juan (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

The Puerto Rico Consortium for Clinical Investigation (PRCCI) seeks a Clinical Trials Site Manager to lead daily operations at the PRCCI Clinical Research Center in San Juan. You will oversee study conduct, regulatory compliance, sponsor communications, and site performance.

This role requires experience in GCP/ICH, staff supervision, budget oversight, and the ability to collaborate with investigators and vendors while ensuring participant safety and data integrity.

Qualifications

• Demonstrated ability to interpret and apply complex regulatory requirements, guidelines, and institutional policies to clinical research operations.
• Thorough knowledge of applicable clinical research regulations and standards including GCP, ICH, FDA, IRB and HIPAA.
• Experience implementing and overseeing industry-sponsored clinical trials within the life sciences sector.

Responsibilities

• Oversee day-to-day operations of multiple clinical trials from start-up to close-out.
• Ensure regulatory submissions, approvals, renewals, and notifications are completed accurately and on time.
• Lead staff supervision and development, including evaluations and workload management.
• Coordinate sponsor monitoring visits, site assessments, and budgets in collaboration with leadership.
• Promote data quality, integrity, and adherence to study protocols.

Skills

Leadership

Regulatory knowledge

Regulatory compliance

Communication

Project management

Staff supervision

Cross-functional collaboration

Bilingual (Spanish/English)

Education

Advanced degree in life sciences

Tools

CTMS

EDC systems

Document management systems

AI tools

Job description

The Puerto Rico Consortium for Clinical Investigation (PRCCI) seeks a Clinical Trials Site Manager to lead daily operations at the PRCCI Clinical Research Center in San Juan. You will oversee study conduct, regulatory compliance, sponsor communications, and site performance.

This role requires experience in GCP/ICH, staff supervision, budget oversight, and the ability to collaborate with investigators and vendors while ensuring participant safety and data integrity.