Job Description
The Clinical Research Specialist II provides Clinical Research expertise by participating in the design and implementation of research projects as needed.Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. 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 DruThe Clinical Research Specialist II provides Clinical Research expertise by participating in the design and implementation of research projects as needed.Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. 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 (IRB).
Primary Duties and 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.
• 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.
• Provides research writing activities such as developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols.
• Serves as an internal advisor for specific departmental activities.
• Provides guidance regarding project planning, project logistics, and project implementation. Administration (FDA) and local Institutional Review Board (IRB).

Qualifications
Education
Bachelor’s degree required.
Work Experience
5 years of experience in area of research specialty. Experience in spine research, training and development of research staff, recruitment strategies and clinical improvement of productivity highly desired.
Req ID : 1195
Working Title : Clinical Research Specialist II -Dept of Orthopaedics
Department : Dept of Orthopaedics
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $78,332 - $133,161