Clinical Research Coordinator

$62,400 - $72,800/Yr

Actalent - Pasadena, CA

Full-time - Mid Level

Pasadena, CA

10,001+ employees

Administrative and Support Services

About the position

The Clinical Research Coordinator (CRC) is responsible for managing multiple clinical trials while ensuring adherence to research protocols, Good Clinical Practices, and regulatory standards. This role involves direct patient interaction, maintaining accurate records, and ensuring informed consent. The CRC plays a crucial role in the clinical research process by overseeing trial operations and ensuring compliance with study protocols.

Responsibilities

• Administratively and clinically manage an average of six to eight clinical trials
• Adhere to Research SOPs, Good Clinical Practices, and Study Protocols
• Discuss Study Protocols with patients and verify informed consent information
• Provide patients with written communication of their participation, including copies of signed consent forms
• Meet with patients for each visit and maintain accessibility to discuss study-related questions or concerns
• Complete screening visits according to protocol and take detailed and accurate medical histories
• Gather comprehensive patient information and medical histories prior to screening visits to identify potential issues or exclusions
• Dispense study medication professionally and accountably following protocol requirements
• Collect, process, and ship blood/urine specimens if a Research Assistant is unavailable
• Document and report both non-serious and serious adverse events
• Screen laboratory results upon receipt and follow procedures for abnormal results
• Ensure all laboratory results are reviewed by the Principal Investigator (PI) for clinical significance
• Keep delegation logs and training logs current; train staff on new protocol amendments
• Review and comprehend study protocols, proceedings, timelines, inclusion and exclusion criteria, and confidentiality/privacy protections
• Attend investigator meetings as required and approved by the PI and Lead Study Coordinator
• Create study-specific source documentation

Requirements

• Active GCP certification
• Ability to read and understand protocols and schedules of events
• Minimum of 5 years of Clinical Research experience
• Thorough understanding of FDA, ICH, and GCP guidelines
• Experience with Phase I-IV clinical trials
• Proficiency with Microsoft Office Suite
• Excellent interpersonal, verbal, and written communication skills
• Comfort with medical terminology and EKGs
• BCLS training required

Nice-to-haves

• IATA certification (preferred)
• Bilingual abilities, especially Spanish (preferred)
• Experience at a busy institution with a broad range of research responsibilities
• Familiarity with the full lifecycle of clinical research, from specimen processing to regulatory work

Benefits

• Pay range of $30.00 - $35.00