Clinical Research Coordinator

CLINICAL RESEARCH COORDINATOR

JOB PURPOSE

The Clinical Research Coordinator will coordinate and manage all aspects of clinical research studies, ensuring compliance with protocols, regulatory requirements, and ethical standards. This role involves recruiting and screening potential study participants, collaborating with healthcare professionals, monitoring adverse events, and maintaining meticulous documentation. Fluency in Spanish is preferred for this position.

ESSENTIAL JOB FUNCTIONS

• Study Coordination : Coordinate and manage all aspects of clinical research studies, ensuring compliance with protocols, regulatory requirements, and ethical standards.
• Participant Recruitment : Recruit and screen potential study participants, explaining the study details, obtaining informed consent, and ensuring eligibility criteria are met.
• Clinical Trial Monitoring : Work with monitors and auditors to facilitate site visits, ensuring that the study is conducted in accordance with protocol, Good Clinical Practice (GCP), and applicable regulations.
• Collaboration with Investigators : Collaborate with principal investigators, physicians, and other healthcare professionals involved in the study. Communicate regularly to address issues and ensure the smooth progress of the research.
• Adverse Event Reporting : Monitor and report adverse events, ensuring timely and accurate reporting to regulatory authorities, sponsors, and other relevant stakeholders.
• Documentation and Record Keeping : Maintain accurate and organized study documentation, including case report forms, source documents, and other study-related records.
• Quality Assurance : Implement quality assurance processes to ensure the integrity of study data and compliance with regulatory standards.
• Communication Skills : Effectively communicate with study participants, investigators, sponsors, and other stakeholders. Provide regular updates on study progress and address inquiries.
• Problem-Solving : Identify and resolve issues or challenges that may arise during the course of the study, working proactively to prevent potential problems.

QUALIFICATIONS AND EXPERIENCE

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

DIRECT REPORTS

This position does not have any direct reports but will work closely with study team members, including research assistants, data coordinators, and other staff involved in the study.