Clinical Research Coordinator II, Neonatal Research (Evening, Grant Funded)

CHOC Children's provides pediatric healthcare and conducts innovative research to support children's health. The Clinical Research Coordinator II supports multiple human-subjects clinical research projects in neonatal research, managing study feasibility, regulatory submissions, participant identification, data and specimen collection, study records, quality assurance, materials, communications, and archiving.

Responsibilities

• Providing coordinator support to multiple human subjects’ (clinical) research projects
• Perform all core Clinical Research Coordinator (CRC) responsibilities
• Assessing feasibility of clinical research protocols
• Preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB)
• Identifying potential study participants
• Coordinating and collecting research data/specimens
• Completing study records in an accurate and timely manner
• Participating in quality assurance audits
• Managing study materials and supplies
• Communicating across multiple teams
• Archiving records in accordance with appropriate policies and procedures

Preferred

• Preferred: Clinical research experience in a hospital setting and/or pediatric clinical research experience
• Preferred: Bachelor's degree in a relevant field
• Preferred: Ability to conduct informed consent
• Working knowledge of Cerner or equivalent electronic medical record system
• Knowledge of sample identification, processing and storage
• Preferred: Phlebotomy certification
• Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
• Clinical Research Experience
• Hospital Research Experience
• Pediatric Clinical Research
• Relevant Bachelor's Degree
• Informed Consent
• Cerner
• Electronic Medical Records
• Sample Identification
• Sample Processing
• Sample Storage
• Phlebotomy Certification
• ACRP-CP Certification
• CCRP Certification
• CCRC Certification

Company

• Children's hospital providing world-class pediatric care
• Orange, California, USA
• http://www.choc.org/
• Founded in 1964
• 1001-5000 employees

Qualifications

• Required: Minimum three years of clinical research coordination experience
• Required: Associate degree or equivalent additional experience can be accepted in lieu of education
• Required: Basic knowledge of key Microsoft Office programs (Word, Excel, PowerPoint)
• Demonstrate strong interpersonal skills
• Able to communicate effectively both orally and in writing
• Be detail oriented
• Able to work under pressure in a fast-paced environment while managing multiple competing priorities
• Working knowledge of human subjects' regulatory requirements, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH-GCP)
• Required: Basic Life Support (BLS) - American Heart Association. If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 6 months of assuming position. With management approval, the time in which to obtain certification may be extended past 6 months due to extenuating circumstances
• Preferred: Clinical research experience in a hospital setting and/or pediatric clinical research experience
• Preferred: Bachelor's degree in a relevant field
• Preferred: Ability to conduct informed consent
• Working knowledge of Cerner or equivalent electronic medical record system
• Knowledge of sample identification, processing and storage
• Preferred: Phlebotomy certification
• Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
• Required: Minimum three years of clinical research coordination experience.

Required skills

• Basic Life Support (BLS), Cerner, Clinical Research Coordination, Human Subjects Research Regulations, ICH-GCP, Informed Consent, Sample Identification, Processing, and Storage

Preferred skills

• $2M, 2022-06-01, 2023-11-21, 2025-01-08, 2026-05-23, 4.1, AI's promise meets the pediatric frontline, Acquired, Baldrick's Foundation, Chief Operating Officer, Glassdoor, Grant, Grant· $2M, HealthCareIT News, Key Investors, Kim Milstien, Kimberly Cripe, Knowledge of sample identification, processing and storage, Late Stage, Leadership Team, Orange, California, USA, PR Newswire, Preferred: Ability to conduct informed consent, Preferred: Bachelor's degree in a relevant field, Preferred: Phlebotomy certification, President and CEO, Recent News, Total Funding, Tsao Family Foundation, http://www.choc.org/

Experience

• 3+ years