Clinical Research Coordinator

Description

• Comply with company policies, HIPAA, OSHA regulations, and Standard Operating Procedures (SOPs) to deliver high-quality services.
• Collaborate with laboratories to process, ship, and ensure review of investigational reports.
• Schedule and coordinate research visits, assessments, and procedures, ensuring all requirements are met.
• Manage and oversee the execution of clinical trials under the direction of the Principal Investigator and Site Manager.
• Maintain accurate case report forms, cross-referencing patient medical records for completeness and FDA compliance.
• Maintain organized records of study materials, ensuring all regulatory documentation is up to date.
• Actively participate in recruiting and screening study participants.
• Ensure necessary supplies and equipment are available and functional for each study.
• Monitor study participants, ensuring adherence to study guidelines and ethical standards.
• Conduct patient visits and ensure adherence to study protocols, collecting and processing biological specimens (blood/urine) and performing procedures such as ECGs and vital signs monitoring.
• Manage investigational medications, including receiving, dispensing, and performing drug accountability.
• Collect, enter, and manage clinical data while maintaining confidentiality.
• Administer questionnaires, diaries, and other participant materials as per protocol.

Requirements

• Clinical research experience, particularly in interventional clinical trials.
• Preferred: Bilingual proficiency in Spanish or Vietnamese.
• Ability to receive and act on feedback from the Principal Investigator.
• Preferred: Certification as a Clinical Research Coordinator (CCRC).
• Good bedside manner and soft skills.
• Education: High School Diploma or GED required, Bachelor's or Master's degree in a related field preferred.
• Proficiency in Good Clinical Practices (GCP) and FDA regulations.
• Preferred: Medical Assistant or Phlebotomy certification.
• Problem-solving skills.

Benefits

• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Fountain Valley,CA. Application Deadline This position is anticipated to close on Dec 23, 2025.
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Transportation benefits
• Medical, dental & vision
• Health Spending Account (HSA)
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance