Clinical Research Coordinator II

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. #J-18808-Ljbffr Children's Hospital Los Angeles (CHLA)