Clinical Research Specialist II (Monitoring/Auditing Focus)

Cedars-Sinai•Beverly Hills, CA

15h•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 role is responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. The specialist may implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. They ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). While this is a hybrid role, it does require onsite presence for IMVs and audits as needed, and therefore, only candidates residing in the local area who can come onsite when required will be considered.

Requirements

Reside in the local area and be able to come onsite when required for IMVs and audits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
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

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