Senior Clinical Research Coordinator

Senior Clinical Research Coordinator (Fixed Term Contract)

Job Title: Senior Clinical Research Coordinator

Reports to: Clinical Research & Business Development Supervisor

Location /

Hours:

San Juan, Puerto Rico / Full-Time

Type of

Contract:

Fixed Term Contract (1 year contract)

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 startup processes. All current employees get involved in various aspects of the organization and everyone is contributing to the overall success of the company.

The Senior Clinical Research Coordinator (CRC) is a resourceful, detail oriented, and collaborative team member with excellent people management skills. The primary role of this position is to support, facilitate and coordinate daily clinical trial activities and play a critical role in the study conduct ensuring that the study meets its intended goals and that the local team conducts the clinical trial in compliance with all local, federal and global regulations.

The Senior CRC communicates with the study stakeholders for the successful implementation of the clinical trial. The ideal candidate will play a key role in managing clinical trials across multiple therapeutic areas and multiple sites, ensuring compliance with regulatory requirements and study protocols while maintaining the highest standards of participant safety and data integrity. The position requires regular travel to study sites, making it essential for the candidate to be adaptable and organized.

The Senior CRC oversees and manages CRCs in daily activities including but not limited to assisting study start‑up; recruiting, enrolling, and retaining participants in the study; performing study assessments and follow‑ups; data entry and management; and facilitating community outreach and stakeholder engagement activities. The Senior CRC is responsible for coordinating some studies and for overseeing the coordination of other studies.

• Review and become familiar with the study protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc.
• Conduct the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places.
• Assure that amended consent forms are appropriately completed and signed.
• Responsible for Data Delinquency, and completion of queries in a timely manner.
• Educate and inform the research staff and investigators on everything related to the protocol: amendments, safety reports, etc.
• Creation and implementation of recruitment strategies.
• Meet periodically with PI and sponsor’s staff (e.g., Clinical Research Associates) to discuss progress and for site visits.
• Responsible for patient recruitment and Retention for assigned studies.
• Maintain direct communication with the PI, investigators, and clinical research coordinators (CRCs).
• Review and pre‑screen new patient charts or EHR to determine if they qualify for a protocol.
• Responsible for overseeing patient eligibility to participate in the study.
• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Inform subjects of the imaging studies and other…