Clinical Research Coordinator

Job Description

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

1. Study Coordination : Coordinate and manage all aspects of clinical research studies, ensuring compliance with

protocols, regulatory requirements, and ethical standards.

2. Participant Recruitment : Recruit and screen potential study participants, explaining the study details,

obtaining informed consent, and ensuring eligibility criteria are met.

3. 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.

4. 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.

5. Adverse Event Reporting : Monitor and report adverse events, ensuring timely and accurate reporting to

regulatory authorities, sponsors, and other relevant stakeholders.

6. Documentation and Record Keeping : Maintain accurate and organized study documentation, including case

report forms, source documents, and other study-related records.

7. Quality Assurance : Implement quality assurance processes to ensure the integrity of study data and

compliance with regulatory standards.

8. Communication Skills : Effectively communicate with study participants, investigators, sponsors, and other

stakeholders. Provide regular updates on study progress and address inquiries.

9. Problem-Solving : Identify and resolve issues or challenges that may arise during the course of the study,

working proactively to prevent potential problems. Please be advised that job duties and locations may change based on the needs of the Company

QUALIFICATIONS AND EXPERIENCE

1. Bachelor's or advanced degree in a relevant field is preferred but not required.

2. Experience in clinical research and knowledge of regulatory requirements.

3. Strong organizational, communication, and interpersonal skills are essential for success in this role.

4. Spanish-speaking preferred.

5. Willingness to travel to different locations between Los Angeles and Orange County is required for this

position.

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

1. This position may require working in a clinical setting, with frequent interaction with patients, healthcare

professionals, and study participants.

2. Regular travel between study sites in Los Angeles and Orange County.

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.