Oncology Research Registered Nurse (RN)-Clinical Research Coordinator

Job description:-

Position Name: Clinical Research Coordinator-RN

Department: Cancer Clinical Research

Type: Full Time/Permanent - Direct Hire

Location: Newport Beach, CA,92663

Available Shifts: M-F 8:30 – 5 pm (based on patient schedule)

Pay Rate: $52-$75/hour plus benefits

Overview:
We are seeking a dedicated and highly organized Clinical Research Coordinator - Registered Nurse (RN) to join our dynamic research team. This pivotal role involves overseeing clinical trial activities, ensuring compliance with regulatory standards, and providing comprehensive patient care throughout the research process. The ideal candidate will possess strong nursing expertise combined with experience in clinical trials management, demonstrating a commitment to advancing medical knowledge and patient safety. This position offers an excellent opportunity to contribute to innovative clinical development projects within a collaborative environment.

Duties

• Coordinate and manage all aspects of clinical trials, including patient recruitment, enrollment, and follow-up procedures, ensuring adherence to protocol guidelines.
• Monitor patient health status through vital signs assessment, blood sampling, and ongoing observation, documenting findings accurately within electronic medical record (EMR) systems.
• Review and verify clinical documentation for completeness and compliance with FDA regulations, ICH Good Clinical Practice (GCP) standards, and CDISC data standards.
• Conduct phlebotomy procedures, blood sampling, and other clinical laboratory tasks with precision and safety.
• Ensure proper data collection, management, and reporting using statistical software tools; maintain meticulous records for audit readiness.
• Oversee compliance with HIPAA regulations and institutional policies to safeguard patient confidentiality.
• Supervise research staff and coordinate training activities related to protocol procedures, documentation review, and regulatory compliance.
• Collaborate with multidisciplinary teams including physicians, laboratory personnel, and regulatory bodies to facilitate smooth trial operations.
• Assist in the preparation of regulatory submissions, progress reports, and audit documentation.
• Maintain knowledge of FDA regulations, ICH GCP guidelines, and clinical laboratory best practices to ensure ongoing compliance.

Required Skills & Experience:
-Two (2) or more years of experience performing clinical research duties or equivalent experience and training.
-Excellent analytical and problem-solving skills.
-Excellent verbal and written communications and presentation skills; excellent organizational skills; close attention to detail and excellent interpersonal skills to work effectively in a diverse team.
-Ability to work effectively in a fast-paced, team-based environment; project management and coordination skills; ability to prioritize tasks and meet multiple deadlines on concurrent projects.
-Ability to establish cooperative working relationships with patients, co-workers, & physicians.
-Behaves in a professional manner in all settings and promotes team building.
-Follows policies set by the organization and department.Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines.
-Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
-Ability to abstract data from medical records and transfer it to data collection forms or directly into databases.
-Proficiency with Microsoft Word, PowerPoint, and Windows.

Preferred Skills & Experience:
-Working knowledge of FDA, NIH, and OHRP regulatory requirements.
-Working knowledge of ICH Good Clinical Practice guidelines.
-Understanding of clinical trial methodologies.
-Experience filing Institutional Review Board documentation.
-Ability to abstract data from medical records and transfer information into data collection forms or electronic databases.

Required Certifications & Licensure:
-Current licensure in good standing as a Registered Nurse in the State of California.
-Basic Life Support (BLS) Certification.