Clinical Research Coordinator

About the role

The UC Irvine Health School of Medicine's Department of Neurology is seeking a Clinical Research Coordinator to lead the day-to-day execution of assigned clinical research studies. This position plays a key role in assisting Principal Investigators in recruiting patients for clinical studies and meeting enrollment and retention goals.

Responsibilities

• Independently execute and document assigned clinical research studies in accordance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, internal Standard Operating Procedures (SOPs), FDA regulations, and University policies and procedures.
• Pre-screen and recruit study subjects, conduct chart reviews, schedule subject visits, assist with appropriate study testing, collect data, and complete data entry.
• Maintain communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
• Interact with subjects, clinic and research staff, laboratory staff, radiology staff, and any other medical professionals associated with our clinical research protocols.
• Manage clinical study information in the clinical trial management system (OnCore) and adhere to institutional policies.
• Work remotely for some tasks such as patient screening, telephone encounters, meetings, and education development.

Requirements

• Establish and maintain effective working relationships across the Health System.
• Adapt to a rapidly changing work environment and meet rigid deadlines despite interruptions, frequent workload changes, and competing demands.
• Maintain high productivity/quality within short time frames and achieve high productivity/quality within short time frames.
• Exercise discretion and sound judgment, maintain confidentiality, and demonstrate flexibility and adaptability.
• Establish and maintain files and records.
• Read and understand clinical trial protocols, and have working knowledge of FDA regulations, GCP/ICH guidelines, and applicable clinical trial regulations.
• Have working knowledge of various types of human subject clinical trials and knowledge of clinical trial federal, state, and local regulation requirements.
• Have demonstrated strong data management skills and attention to detail.
• Provide excellent customer service experience for patients and respond to patient needs in a timely manner.
• Interact with patients and caregivers in a compassionate and empathetic manner.
• Have a proven track record of human subjects research coordination, informed consent procedures, and documentation.
• Have experience working in a medical/clinical setting and familiarity with medical terminology.
• Have a Bachelor’s degree in related area or equivalent combination of education and/or equivalent experience.
• Have a minimum of 2 years of related work experience as a clinical research coordinator (CRC) or an assistant CRC.

Preferred

• Knowledge of various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored).
• Knowledge of clinical trial federal, state, and local regulation requirements.
• Familiarity with medical terminology and medical/clinical environment.
• Experience working in a medical/clinical setting.