The Clinical Research Specialist 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).
Provides clinical research expertise by participating in the design and implementation of research projects and care of research patients 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.
Implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
Provides guidance regarding project planning, project logistics, and project implementation
Serves as an internal consultant for specific departmental activities.
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 clinical expertise and support with quality assurance, performance improvement, and health plan compliance for clinical trial compliance.
Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according FDA, HSPC, HIPAA an d other agency guidelines.
Responsible for insuring timely submission of complete, accurate and neat documents to research sponsors, IRB, and contract research organizations, where applicable.
Participates in weekly research staff meetings.
Acts as a liaison with Principal Investigators, pharmaceutical company representatives and other project funding organizations to monitor and update project progress.
Prepares for institutional, pharmaceutical and internal audits, including facilitating third party study monitoring.
Attends site feasibility visits and site initiation visits for potential studies, and assures that new studies are implemented according to protocol.
Review pertinent medical records to determine opportunities for quality improvement. Analyze quality metric data in support of the Principal Investigator and Director of Clinical Services.
Associates Degree required
BA/BS, MS/MA/MPH degree in related field preferred
SOCRA Certification preferred
5 years minimum research specialty with knowledge of IRB clinical research application procedures preferred
Pharmaceutical/Biotechnology or Contract Research Organization (CRO) preferred
Clinical Coordinator experience preferred in Cardiology, Surgery or Infection Disease
Experience in federal grant proposal development and grant submissions, and knowledge of IRB clinical research application procedures preferred
Working Title: Clinical Research Specialist
Business Entity: Medical Network Foundation
City: Beverly Hills
Job Category: Academic / Research
Job Specialty: Research Studies / Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Full-time