Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Reports to: Associate Director (PRCCI)

Location / Hours: San Juan, Puerto Rico / Full-Time

Type of Contract: Fixed Term Contract (1 year contract)

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

The Clinical Research Coordinator supports the successful implementation and execution of research and grant-related activities by providing operational, administrative, and project coordination support to the Principal Investigator (PI) and Project Team. This role ensures timely completion of project objectives, facilitates collaboration across teams, and contributes to maintaining high standards of accuracy, organization, and client service throughout all phases of the project.

Key Responsibilities and Duties

Study Preparation and Startup:

• Coordinate study start-up activities, including regulatory submissions (IRB/IEC), protocol implementation, and site initiation.
• Develop and maintain study documents such as source documents, case report forms (CRFs), study binders, and standard operating procedures (SOPs).
• Ensure compliance with NIH, FDA, ICH-GCP, and institutional guidelines.

Participant Recruitment and Enrollment:

• Identify, screen, and recruit eligible participants according to protocol inclusion/exclusion criteria.
• Conduct informed consent discussions and ensure proper documentation of consent.
• Maintain recruitment logs and track enrollment progress against study targets.

Study Coordination and Execution:

• Schedule and coordinate study visits, procedures, and assessments per protocol.
• Collect, process, and ship biological specimens as required.

Data Management and Quality Control:

• Accurately collect, enter, and maintain study.
• Ensure data integrity, completeness, and timeliness.

Regulatory Compliance and Documentation:

• Maintain essential regulatory documents (e.g., investigator site file, consent forms, training logs).
• Prepare for and support monitoring visits, audits, and inspections.
• Ensure ongoing compliance with NIH policies and reporting requirements.

Communication and Collaboration:

• Serve as the primary liaison between investigators, sponsors, clinical staff, and participants.
• Coordinate with multidisciplinary teams (e.g., physicians, nurses, lab personnel).
• Participate in investigator meetings, site visits, and study-related calls.

Financial and Administrative Oversight:

• Track study-related expenses and assist with budget management.

Reporting and Closeout Activities:

• Prepare progress reports, enrollment updates, and final study reports for NIH and stakeholders.
• Assist with study closeout procedures, including data lock, archiving, and regulatory submissions.

Training and Education:

• Maintain current certifications (e.g., GCP, human subjects' protection).
• Train site staff on study protocol, procedures, and compliance requirements as needed.

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 will change to meet these challenges.

Qualifications & Technical Job Requirements

• Excellent written and verbal communication skills in both English and Spanish.
• Outstanding customer service and interpersonal skills when interacting with clients and participants.
• Ability to work collaboratively with team members in a dynamic and fast-paced work environment.
• Manages time and priorities effectively.
• Apply new skills and concepts quickly and display a willingness to learn and improve.
• Superior working knowledge of office applications and online collaboration tools, such as Microsoft 365 Suite, Google products, SharePoint, One Drive, Dropbox, Adobe PDF, Docusign, Zoom, etc.
• Ability to learn new processes and use company-specific software.
• A strong work ethic, ability to maintain and model high personal, ethical, and professional standards, as well as an outgoing and positive personality.
• Occasionally, it may be required to work outside regular business hours to complete special projects and reports or to attend company events.

Experience & Educational Requirements

• BA/BS degree in health-related field, or a minimum of three years' experience in clinical trials research setting as a data manager/CRA/CRC/other similar role. Advanced degree with relevant experienced desired. Grant management a plus.
• Proven work experience as a Clinical Research Coordinator or similar role.

"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."