Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Location: Pasadena, CA

Employment Type: Full-Time

Position Overview:

We are seeking a highly motivated and organized Clinical Research Coordinator (CRC) to join our team in Pasadena, CA. The ideal candidate will play a key role in managing and coordinating clinical trials, ensuring compliance with regulatory guidelines and study protocols. As a CRC, you will work closely with clinical teams, patients, and sponsors to facilitate the successful execution of clinical research projects.

Key Responsibilities:

• Oversee and coordinate the day-to-day operations of clinical trials, including patient recruitment, screening, and enrolment.
• Obtain informed consent from study participants, ensuring they understand the nature of the study.
• Manage study documentation, including data entry, case report forms (CRFs), and regulatory binders.
• Coordinate with principal investigators, research teams, and sponsors to ensure proper implementation of protocols and timelines.
• Ensure compliance with FDA, IRB, and GCP (Good Clinical Practice) guidelines.
• Prepare and submit IRB applications and amendments, ensuring timely approval for study start-up and modifications.
• Schedule and conduct patient visits, collecting and recording accurate data for study endpoints.
• Monitor patient safety and report adverse events (AEs) and serious adverse events (SAEs) in accordance with study protocols.
• Assist with study audits, site visits, and inspections by regulatory agencies and sponsors.
• Maintain clear and effective communication with all study stakeholders, including study participants, investigators, and clinical staff.

Qualifications:

• Bachelor's degree in a health-related field (e.g., biology, nursing, public health) or equivalent clinical experience.
• 2+ years of experience in clinical research or healthcare setting, preferably as a Clinical Research Coordinator or similar role.
• Knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes.
• Excellent organizational and multitasking skills with the ability to manage multiple trials simultaneously.
• Strong attention to detail and commitment to maintaining high-quality standards.
• Excellent interpersonal and communication skills, with the ability to work collaboratively in a team environment.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and clinical trial management systems (CTMS).
• Certified Clinical Research Coordinator (CCRC) or willingness to obtain certification is preferred.
• Bilingual (English/Spanish) is a plus.

Benefits:

• Competitive salary based on experience
• Health, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Professional development opportunities
• Work in a dynamic and collaborative environment