Clinical Trials Site Manager in San Juan, Puerto Rico at Puerto Rico Science Technology & Research Trust

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, certifications, and delegation-of-authority records are current and appropriately maintained.Ensure accurate and timely documentation and recordkeeping in accordance with applicable requirements, institutional policies, and established procedures.Maintain appropriate study documentation and records within designated systems, including the Clinical Trial Management System (CTMS), SharePoint, and other applicable electronic platforms.Monitor regulatory developments and communicate relevant changes and their implications to site personnel.Conduct internal compliance reviews and inspections, identify gaps, and develop and implement corrective and preventive action plans (CAPAs), as appropriate.Coordinate site preparation for sponsor audits, regulatory inspections, and monitoring visits, ensuring that findings and follow-up actions are addressed promptly.

Participant Recruitment, Enrollment, and Retention:

Oversee the development and implementation of participant recruitment and retention strategies to support achievement of study enrollment targets.Monitor recruitment, screening, enrollment, and retention metrics, identifying barriers and implementing strategies to address performance gaps.Ensure participant screening, eligibility assessments, informed consent, and study procedures are conducted in accordance with approved protocols and applicable requirements.Promote participant safety, rights, welfare, and confidentiality throughout the clinical trial process.Address participant concerns and collaborate with investigators and site personnel to resolve issues that may affect participant safety, satisfaction, or retention.

Sponsor, Investigator, and Stakeholder Relations:

Serve as a primary point of contact for study sponsors, contract research organizations (CROs), principal investigators, regulatory representatives, and other relevant stakeholders regarding site operations and study activities.Coordinate sponsor monitoring visits, site assessments, and study-related requests, ensuring timely responses and appropriate follow-up.Facilitate communication and collaboration among sponsors, investigators, and site personnel to support study progress and resolve operational issues.Provide regular updates on study status, enrollment progress, key performance indicators (KPIs), milestones, and outstanding action items.Review study contracts and budgets and support contract and budget negotiations in collaboration with organizational leadership and relevant internal stakeholders.

Quality Management and Data Integrity:

Oversee clinical data management activities at the site to promote data accuracy, completeness, consistency, and timely entry into designated systems.Monitor data quality, query resolution, source documentation, and compliance with study-specific data management requirements.Ensure adverse events, serious adverse events, protocol deviations, and other reportable events are documented, escalated, and reported within required timelines in accordance with applicable regulations, approved protocols, and institutional procedures.Monitor adherence to approved protocols and established quality standards and ensure identified deficiencies are appropriately documented and addressed.Develop, implement, and monitor corrective and preventive actions to address noncompliance, audit findings, recurring issues, and opportunities for improvement.Ensure the clinical research site, facilities, and equipment are maintained in appropriate working conditions and meet applicable safety, operational, and regulatory requirements.

Performance Monitoring, Reporting, and Continuous Improvement:

Develop, monitor, and report key performance indicators (KPIs) and operational metrics related to study performance, enrollment, data quality, regulatory compliance, and site productivity.Prepare and submit monthly and other periodic reports, metrics, and performance summaries within established timelines.Analyze performance trends, identify risks and areas for improvement, and recommend appropriate corrective actions to management.Prepare and present study updates, operational reports, compliance findings, and performance metrics at meetings with leadership and other relevant stakeholders.Ensure timely completion of required reports, documentation, and follow-up actions in accordance with organizational expectations and applicable requirements.

Special Projects and Organizational Initiatives:

Lead and manage special projects and strategic initiatives independently or under the direction of the supervisor to support PRCCI’s operational effectiveness, growth, and continued development.Collaborate with internal teams and external partners to coordinate project activities, establish priorities, monitor progress, and achieve defined objectives.Identify opportunities to improve clinical research operations, enhance quality, optimize workflows, and strengthen organizational processes.Adapt to evolving organizational priorities and contribute to initiatives that advance PRCCI’s clinical research mission and strategic goals.

Since our organization is going to change to meet the needs of new designations or projects, you can expect, anticipate, and assume that your job description will change to meet these challenges.

Qualifications & Technical Job Requirements

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 Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, U.S. Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) requirements, and the Health Insurance Portability and Accountability Act (HIPAA).Experience implementing and overseeing industry-sponsored clinical trials within the life sciences sector.Proficiency with clinical research technology platforms, including Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and Document Management Systems, including learn, adapt to, and effectively using new software applications, information systems, and emerging technologies, including artificial intelligence (AI) tools.Excellent organizational, analytical, and critical-thinking skills, with strong attention to detail and a commitment to data accuracy, quality, and integrity.Demonstrated ability to manage multiple clinical trials, competing priorities, operational processes, while meeting established deadlines.Strong leadership, personnel management, and interpersonal skills, with the ability to supervise, mentor, motivate, and support the professional development of clinical research staff.Excellent written and verbal communication skills, in Spanish and English, with the ability to communicate complex regulatory and operational information clearly and effectively to sponsors, investigators, research personnel, and other stakeholders.Proven ability to establish and maintain productive professional relationships and collaborate effectively with internal teams and external partners.Demonstrated initiative, sound judgment, problem-solving skills, and the ability to work independently while contributing effectively within a multidisciplinary team.High standards of integrity, accountability, dependability, adaptability, and professionalism, with a strong commitment to continuous improvement and operational excellence.Ability to work effectively in a dynamic, fast-paced clinical research environment while maintaining a strong focus on participant safety, regulatory compliance, data quality, and study performance.Willingness and ability to travel within Puerto Rico and the United States, as needed, to attend conferences, meetings, industry events, and site or client visits.Flexibility to work outside regular business hours occasionally to attend organizational or sponsor meetings, address time-sensitive operational needs, or complete high-priority projects.

Experience & Educational Requirements

Advanced degree in life sciences discipline (Healthcare professional preferred). 3 + years’ experience managing clinical trials at an industry-sponsored clinical research site. Experience in developing relationships with stakeholders at all levels of the organization.Experience managing NIH sponsored clinical trials. Experience as a Clinical Research Associate (CRA) is preferred.Project management methodology experience is highly desirable.Clinical Research Certification: Current Good Clinical Practice (GCP) training or certification; professional certification such as CCRC, CCRP, or equivalent is preferred.Exposure to and/or knowledge of pharma/biotech industry specifically related to clinical trials (desired).

“The Trust is an equal opportunity employer; we strive to maintain a workplace atmosphere that is free from discrimination. To those ends, the Trust provides equal employment opportunities without regard to race, color, sex, sexual orientation, age, marital status, national origin, social status, political affiliation, religion, physical or mental disability, veteran status, perceived or real domestic violence victim status, sexual harassment victim status, stalking victim status, and/or any other basis protected by law.”