Clinical Research Startup Coordinator

1 day ago

Newport Beach, United States Russell Tobin Full time

Russell Tobin is seeking a Clinical Research Startup Coordinator for a regional health care delivery network.

Job Title: Clinical Research Startup Coordinator

Location: Newport Beach, CA 92663 (On-Site)

Job Type: Direct Hire

Est. Start Date: December 2024

Hours: 8:30 am – 5pm

Pay Range: $37 - $47 per hour


Primary Duties and Responsibilities:

The Clinical Research Start-Up Coordinator will support and participate in all study startup activities for the Center for Clinical Research within the Hospital. This role will collaborate with key stakeholders to ensure all aspects of the study startup process are met including activation timelines, facilitation and communication with internal and external stakeholders.


The Start-Up Coordinator will work closely with the Start-Up Program Manager to support the maintenance of the inventory of status throughout the startup process until internal study activation is granted. This includes working with study teams to closely track and review timelines and key milestones during the start-up phase. This role will support site start-up activities including but not limited to, the review, collection and finalization of Confidentiality Disclosure Agreements Clinical Trial Agreements, Material/Data Transfer Agreements and Disclosure Agreements. This includes corresponding with and providing site level information to sponsors including information about Center’s feasibility process, SQV’s, initial site documentation, budget negotiation, regulatory, and trainings, etc.


This role will interface works closely with sponsors and internal teams to provide the necessary documents/information to meet internal timelines, including studies identified as Rapid Activation trials. This role will support Center leaders in identifying and mitigating obstacles for efficient and reduced study activation timelines. Facilitates an efficient review and execution of clinical trial contracts/agreements. Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.

Communicates project status and improvement areas with leadership in a timely manner. Supports the implementation of department-wide initiatives such as research process improvement efforts. Participates in required training and education programs. Participates in weekly research staff meetings. Must be able to work flexible hours/overtime to meet study deadlines and requirements.


Education and Experience

  • The Clinical Research Department is seeking a detail-oriented clinical research leader with five or more years of clinical research experience
  • At least four years of experience in clinical research regulatory processes
  • 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
  • Bachelor’s degree required; Master’s degree preferred


Certifications Preferred

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



Apply Today If you are interested in the position, please email your resume to rob.vanriet@russelltobin.com for immediate consideration.

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