CLINICAL RESEARCH ACTIVATION COORDINATOR - HOAG CENTER FOR CLINICAL RESEARCH

$76,960 - $76,960/Yr

Hoag Health System - Newport Beach, CA

Full-time - Mid Level

Newport Beach, CA

Hospitals

About the position

The Clinical Research Activation Coordinator at Hoag Center for Clinical Research plays a crucial role in supporting and participating in all study startup activities. This position involves collaboration with key stakeholders to ensure that all aspects of the study startup process are met, including activation timelines and communication with both internal and external parties. The coordinator will work closely with the Start-Up Program Manager to maintain the status inventory throughout the startup process until internal study activation is granted.

Responsibilities

• Support and participate in all study startup activities for the Hoag Center for Clinical Research.
• Collaborate with key stakeholders to ensure activation timelines are met.
• Facilitate communication with internal and external stakeholders.
• Track and review timelines and key milestones during the startup phase.
• Support site start-up activities including the review and finalization of various agreements.
• Correspond with sponsors and provide site-level information regarding feasibility processes and initial site documentation.
• Interface with sponsors and internal teams to provide necessary documents to meet internal timelines.
• Identify and mitigate obstacles for efficient study activation timelines.
• Facilitate the review and execution of clinical trial contracts/agreements.
• Communicate project status and improvement areas with leadership in a timely manner.
• Support the implementation of department-wide initiatives and participate in required training and education programs.

Requirements

• At least four years of experience in clinical research regulatory processes.
• Bachelor's degree required; Master's degree preferred.
• Previous experience working with commercial IRBs.
• In-depth knowledge of clinical oncology.
• Knowledge of patient electronic medical systems and CTMS or similar system.
• In-depth understanding of current medical terminology specific to oncology.
• Familiarity with FDA's Good Clinical Practice for clinical research.
• Knowledge of all components of clinical trials/studies.
• Ability to travel to multiple sites and attend off-site staff meetings as needed.

Nice-to-haves

• Project Management Professional (PMP) certification preferred.
• SOCRA or ACRP certification preferred.

Benefits

• Competitive salary based on experience and location.