Job Description

Clinical Research Specialist II – Clinical Coordinating Center (CCC) at CEDARS-SINAI summary:

The Clinical Research Specialist II at the Clinical Coordinating Center (CCC) manages and coordinates investigator-initiated and multi-site clinical research projects. This role involves design, implementation, regulatory compliance, and communication with internal and external stakeholders to ensure quality and adherence to federal and local regulations. The position is fully onsite and requires expertise in clinical research, protocol development, and research infrastructure management.

Job Description

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.

Within ACRO, the Clinical Coordinating Center (CCC) offers infrastructure and expertise for investigator-initiated trials (IITs) and collaborative, multi-site clinical research. The CCC Clinical Research Specialist II will serve in a cross-functional role and interface with internal and external stakeholders to coordinate all aspects of assigned investigator-initiated and multi-site projects.

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 Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities

• 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.
• 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.

Qualifications

This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.

Requirements:

• Bachelor's Degree required.
• 5 years of experience in clinical research, regulatory, or data coordination required.
• Experience with investigator-initiated and/or multisite research preferred.
• ACRP/ SOCRA (or equivalent) certification preferred.

#Jobs-Indeed

Req ID : 8229
Working Title : Clinical Research Specialist II – Clinical Coordinating Center (CCC)
Department : Enterprise Research Admin
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 : $37.66 - $64.02

Keywords:

clinical research, investigator-initiated trials, multi-site projects, regulatory compliance, protocol development, clinical trial recruitment, FDA regulations, IRB compliance, Good Clinical Practice, research coordination

Job Tags

Internship, Local area, Remote job, Shift work,

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