Clinical Trials Site Manager

Puerto Rico Science Technology & Research Trust

San Juan, PR

Shift: Full time

**Job Title: Clinical Trials Site Manager**

**Reports to: Executive Director (PRCCI)**

**Location / Hours: San Juan, Puerto Rico (On-Site Position) / Full-Time**

**Type of Contract: Regular Position (Probationary Period)**

**Overview of the Organization**

The Puerto Rico Consortium for Clinical Investigation (PRCCI) was formed as part of a strategy that aims to develop Puerto Rico as a clinical research hub.

PRCCI

is a non-for-profit organization, which is supported by the Puerto Rico Science, Technology & Research Trust (PRSTRT), a private non-for-profit organization.

PRSTRT

was created in 2004 to encourage and promote: innovation, transfer, and commercialization of technology & research, and foster the creation of jobs in the technology sector.

The goal of PRCCI is to promote and enhance clinical research and development for the benefit of patients, the Puerto Rican economy and global scientific innovation.

PRCCI

aims to improve the impact, quality, and speed of clinical research in Puerto Rico.

PRCCI

provides a single point of contact connecting sponsors with an experienced, cooperative network of high-quality research sites, providing access to a variety of patient populations, and improving speed of clinical trials through faster patient recruitment and start-up processes.

**Purpose**

This multifaceted role combines clinical trials site management with regulatory oversight to ensure our clinical research activities are conducted in full compliance with applicable laws and regulations.

The Clinical Trial Site Manager (CSM) is responsible for overseeing the day-to-day operations of the PRCCI Clinical Research Center, ensuring the effective, efficient, and compliant conduct of clinical research activities. Key responsibilities include managing site personnel, budget and resources, overseeing the implementation of clinical study protocols, ensuring adherence to applicable regulatory requirements and institutional policies, and serving as the primary liaison among study sponsors, investigators, and site personnel. The CSM also oversees participant recruitment and enrollment, promotes data quality and integrity, and ensures that clinical trials are conducted in accordance with approved study protocols, applicable laws and regulations, and relevant regulatory guidance, while upholding the highest standards of participant safety and research quality.

Success in this role requires adaptability within PRCCI’s dynamic and evolving environment, along with a proactive approach to contributing to special projects and strategic initiatives that support the organization’s continued growth and development.

**Key Responsibilities and Duties**

Clinical Site Operations and Study Management:

• Oversee the day-to-day operations of multiple clinical trials throughout the study lifecycle, from start-up and activation through study close-out and completion of post-close-out activities.
• Ensure clinical trials are conducted in accordance with approved study protocols, applicable regulatory requirements, institutional policies, and established procedures.
• Develop, implement, and maintain standard operating procedures (SOPs), work instructions, and other operational documents to support consistent and compliant clinical research practices.
• Oversee site resources, facilities, equipment, and operational processes to ensure the effective, safe, and efficient conduct of clinical research activities.
• Identify operational challenges, implement process improvements, and promote best practices across clinical research activities.

Staff Supervision and Development:

• Supervise and provide leadership to clinical research coordinators, research nurses, and other assigned site personnel.
• Provide guidance and mentorship on study protocols, clinical research procedures, regulatory requirements, and applicable SOPs.
• Conduct periodic performance evaluations, establish performance expectations, and support staff training and professional development.
• Monitor staff performance and workload to ensure appropriate resource allocation and timely completion of study-related responsibilities.
• Conduct regular meetings with direct reports to review study progress, address operational challenges, and communicate priorities.

Regulatory Compliance and Documentation:

• Oversee site compliance with Good Clinical Practice (GCP), applicable International Council for Harmonisation (ICH) guidelines, U.S. Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) requirements, and other applicable regulatory and institutional requirements.
• Ensure regulatory submissions, approvals, renewals, and required notifications are completed accurately and within established timelines.
• Oversee the maintenance, organization, and completeness of regulatory files, investigator site files, and other essential study documentation.
• Ensure that investigator and study personnel documentation, training records, licenses, cert