Senior Clinical Research Coordinator

About the role

The Puerto Rico Consortium for Clinical Investigation (PRCCI) is a non-profit organization committed to advancing clinical research in Puerto Rico. PRCCI collaborates with the Puerto Rico Science, Technology & Research Trust (PRSTRT) to support innovative research and improve the efficiency of clinical trials.

Responsibilities

• Oversight and management of Clinical Research Coordinators (CRCs)
• Supporting, facilitating, and coordinating daily clinical trial activities
• Ensuring study compliance with local, federal, and global regulations
• Communicating with study stakeholders for successful implementation
• Managing clinical trials across multiple therapeutic areas and sites
• Overseeing the coordination of some studies
• Reviewing and becoming familiar with study protocols
• Conducting the informed consent process
• Ensuring timely completion of data queries
• Educating and informing research staff and investigators
• Maintaining direct communication with the Principal Investigator (PI) and sponsor's staff
• Screening and qualifying potential participants
• Registering participants at the coordinating center
• Maintaining a master list of enrolled patients
• Coordinating specimen collection, packaging, and shipping
• Collecting and registering participant data
• Maintaining records of adverse events
• Keeping track of patient cases and enrollments
• Preparing for and conducting internal and external audits
• Assisting with the preparation of IRB and regulatory submission documents
• Supporting site staff with day-to-day operations and preparing study materials
• Collaborating with the PI to prepare progress reports and articles
• Managing investigation study product (IP) and documentation
• Participating in community outreach activities
• Identifying new clinical trials and preparing assigned reports

Qualifications & Technical Job Requirements

• Excellent written and verbal communication skills in English and Spanish
• Outstanding customer service and diplomacy skills
• Ability to collaborate in a dynamic and fast-paced work environment
• Time management and attention to detail skills
• Quick learning and ability to transfer knowledge to team members
• Superior working knowledge of office applications and online collaboration tools
• Ability to learn and use sponsor and company-specific software
• A strong work ethic, ethical standards, and outgoing personality
• Able to work outside regular business hours for special projects

Experience & Educational Requirements

• Master’s degree in a health-related field or relevant
• Minimum of five years of experience in clinical trials research settings as a data manager, CRA, or other similar roles
• Certification in clinical research (e.g., ACRP or SOCRA, PRCCI) preferred