Clinical Research Nurse Coordinator III - Hybrid

Primary Duties & Responsibilities

• Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed), Cedars-Sinai IRB, External IRB, IACUC and any research committee involved in Pre/Post-award process.
• Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
• Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
• Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings.
• Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• Participates in required training and education programs and may provide training and education of other personnel.
• May participate in centralized activities of the department or institution.
• May plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP's and/or job aids.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Qualifications

• Education: Bachelor's Degree in Nursing or Health Science (minimum); Master's Degree in Nursing or Health Science (preferred)
• Experience: 5 years Clinical nursing experience (minimum); 5 years Clinical research experience (minimum)
• Licenses and Certifications: RN State License - Upon Hire (minimum, California); Basic Life Support - Upon Hire (minimum); Certification In Clinical Research - 1 Year (minimum, SOCRA or ACPR)