Clinical Research Specialist II (Monitoring/Auditing Focus)

Cedars-Sinai Medical Center • Beverly Hills, CA

4d • Hybrid

About The Position

The Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. This is a hybrid role that requires onsite presence for IMVs and audits when necessary, therefore candidates must reside in the local area. The specialist is responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. They may also implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. The role ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Requirements

• Bachelor’s Degree
• 5+ years of experience in the area of research specialty of monitoring/auditing
• Reside in the local area and be able to come onsite when required for IMVs and audits

Responsibilities

• Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance
• Coordinates research projects at an institutional or departmental level
• Communicates project status and improvement areas with leadership in a timely manner
• Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees
• Provides guidance regarding project planning, project logistics, and project implementation
• May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts
• 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
• Participates in required training and education programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees