Senior Clinical Research Project Supervisor at Puerto Rico Science Technology & Research Trust – San Juan, Puerto Rico
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About This Position
Job Title: Senior Clinical Research Project Supervisor
Reports to: Executive Director (PRCCI)
Location / Hours: San Juan, Puerto Rico / Full-Time
Type of Contract: Regular Contract (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.
PRCCI has been impacting the quality, and speed execution of clinical research in Puerto Rico since 2016. We provide a single point of contact for sponsors with an experienced, 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. All current employees get involved in various aspects of the organization and everyone is contributing to the overall success of the company.
Purpose
The Senior Clinical Research Project Supervisor plays a critical role in the execution and oversight of clinical trials at the PRCCI Clinical Research Center. This position combines clinical research/study coordination with project management functions for all clinical studies performed at the clinic to ensure trials are conducted efficiently, within timelines, and in compliance with regulatory standards and PRCCI projects are followed through completion. This role also supports operational planning and cross-functional coordination and ensures high-quality patient care, regulatory compliance, and operational efficiency across a portfolio of studies while contributing to strategic site growth supporting business development activities related to the identification of new projects.
Key Responsibilities and Duties
Clinical Trial Coordination:
- Independently manage multiple clinical trials from startup through closeout.
- Ensure adherence to study protocols, informed consent processes, and patient safety standards.
- Coordinate and conduct subject visits, including screening, consent process, enrollment, and follow-ups.
- Maintain accurate and complete source documentation and case report forms (CRFs/eCRFs).
- Track and report adverse events (AEs/SAEs) and protocol deviations in a timely manner.
Project Management:
- Develop, track, and maintain study timelines, milestones, and deliverables for PRCCI projects.
- Coordinate startup activities including feasibility assessments, regulatory submissions (IRB/EC), and site initiation visits.
- Act as a point of contact for sponsors, CROs, and vendors at PRCCI for the identification of new projects.
- Monitor study progress, identify risks/issues, and implement corrective actions.
- Assist the Finance Analyst in budget tracking, invoicing support, and systems/platform data entry of assigned studies.
- Maintain updated status of all projects within PRCCI and the Clinical Research Center.
Regulatory & Compliance:
- Ensure adherence to GCP, ICH, FDA and other applicable regulations.
- Support internal and external audits and site assessments conducted by sponsors and external parties providing the necessary documentation.
- Implement and adherence to Standard Operating Procedures (SOPs).
- Prepare and maintain regulatory binders and essential documents in compliance with GCP, ICH, and FDA regulations.
- Ensure proper documentation and reporting requirements are met for assigned projects.
Team Collaboration & Mentorship:
- Support training of new hires and ongoing team development.
- Collaborate with investigators, sub-investigators, and site leadership to ensure study success.
- Participate in cross-functional team meetings.
Operational Support & Process Improvement:
- Identify workflow improvement opportunities and recommend process improvements.
- Support implementation of SOPs and best practices.
- Contribute to business development efforts identifying and tracking project leads and new opportunities.
Proposals & Feasibility:
- Participate in clinical trial feasibility assessments and site selection.
- Support the development of proposals and responses to sponsor requests for proposals (RFPs).
- Evaluate protocol requirements against patient population availability and operational capacity.
- Contribute to study startup planning and ensure smooth transition from award to activation.
Grants & Federally Funded Project Management:
- Assist in the management of federally funded research projects and grants.
- Ensure compliance with grant requirements, reporting deadlines, and federal regulations.
- Track milestones, deliverables, and financial performance for grant-funded studies and private funded studies.
- Maintain audit-ready documentation and support financial reconciliation and closeout.
Additional demands:
- Clinical research site setting with patient-facing responsibilities.
- Fast-paced, deadline-driven environment.
- May require schedule flexibility based on study demands.
Since our organization is going to change to meet the needs of our stakeholders and to fulfil our business plan, you can expect, anticipate, and assume that your job description will change to meet these challenges.
Qualifications & Technical Job Requirements
- Strong knowledge of clinical trial processes, GCP, and regulatory requirements.
- Solid project management and organizational skills.
- Ability to work independently and manage competing priorities.
- Strong attention to detail and problem-solving abilities.
- Effective communication and stakeholder management skills.
- Financial and budget tracking experience.
- Effective communication and stakeholder management.
- Mentorship and team leadership skills.
- Proficiency with CTMS, EDC systems, and Microsoft Office.
- Experience/knowledge of CTMS, data analytics and Microsoft Office.
Experience & Educational Requirements
- Bachelor’s degree in Life Sciences, Nursing, Public Health, or related field. Master’s degree preferred.
- 3+ years of clinical research experience.
- 1+ years’ experience managing multiple research projects simultaneously.
- Exposure to federal proposals and grant management (desirable).
Certifications (Preferred):
- Certified Clinical Research Coordinator (CCRC), or equivalent.
- Project Management certification (PMP or equivalent) a plus.
“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.”
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Job Location
Job Location
This job is located in the San Juan, Puerto Rico, 00927, United States region.