Clinical Research Coordinator II

Children's Hospital Los Angeles (CHLA); Los Angeles (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Children's Hospital Los Angeles (CHLA) is seeking a Clinical Research Coordinator II to manage pediatric trial protocols, coordinate specimen handling, and ensure regulatory compliance.

The role involves coordinating data extraction from EMR, assisting with IRB submissions, and contributing to study start-up activities, budgets, and invoicing. ACRC/SOCRA certification is preferred, with a degree in a related scientific field required.

Qualifications

• 3+ years experience in clinical trial coordination; 1+ year pediatric trials experience required.
• Regulatory experience preferred.
• Clinical Research Study Start-Up experience preferred.
• ACRP/SOCRA certification required or candidates with a medical degree exempt.

Responsibilities

• Coordinate specimen collection, processing, shipment, and storage.
• Assist with extracting data from EMR and reporting via paper or electronic capture systems.
• Submit IRB applications and manage regulatory binders and amendments.
• Support start-up of new studies, including budgets and contracts.

Skills

Regulatory experience

Pediatric clinical trials experience

EMR data extraction

Education

Bachelor's degree or Associate degree in related scientific field

ACRP Certified Clinical Research Coordinator (CCRC)

SOCRA Certified Clinical Research Professional (CCRP)

Tools

EMR systems

Data capture systems

Job description

Schedule: Monday-Friday; 8:00 AM-5:00 PM

Purpose Statement/Position Summary:

The Clinical Research Office is responsible for reading/understanding/following clinical research protocols, coordinating specimen collections, processing, shipment, storage, and coordinating manufacturing/receipt of treatment (as applicable), treatment, follow-up. They also assist with extracting data from EMR and original source and reporting (via paper or electronic data capture systems), safety reporting, IRB submissions for new studies, amendments, continuing reviews, close outs, and maintaining regulatory binders. Starting up new studies- budgets/contracts, reading/understanding Medical Coverage Analysis, IRB application, ancillary department approvals, regulatory documents, as well as invoicing for the study. As a certified research professional, the Clinical Research Coordinator II handles clinical trial administration for all protocol phases. Serves as a resource for study team members and principal investigators and assists with subject recruitment, data collection, scheduling of study-related activities and follow-up with enrolled subjects. Assists in quality assurance/control of data resulting from studies. Provides cross-coverage for other CRCs within the department.

Minimum Qualifications/Work Experience:

3+ year experience in clinical trial coordination with 1+ years pediatric clinical trials experience required.

• Regulatory experience preferred.
• Clinical Research Study Start-Up experience preferred.

Education/Licensure/Certifications

Required

• Bachelor's degree or associates degree in related scientific field.
• ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP). *Candidates with a medical degree are exempt from certification requirement.