Senior Clinical Research Project Supervisor

Puerto Rico Science Technology & Research Trust•San Juan, PR

6d•Onsite

About The Position

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.

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.
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.

Nice To Haves

Exposure to federal proposals and grant management (desirable).
Certified Clinical Research Coordinator (CCRC), or equivalent.
Project Management certification (PMP or equivalent) a plus.

Responsibilities

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.
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.
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.
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.
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.
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.
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.