Clinical Research Start Up Coordinator- Urgent

Clinical Research Start-Up Coordinator

100% onsite in Newport Beach, CA.

Schedule: 8:30 am – 5pm Direct Hire Exempt Onsite (no remote)
 

Job Summary:
Will support and participate in all study startup activities for the Hospital Center for Clinical Research (HCCR) 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.

Required Skills & Experience: 
-The Clinical Research Department is seeking a detail-orientated 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 understanding of current medical terminology  specific to 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. 
-Maintains knowledge of technology, tools, equipment and other devices in work area. 
-Demonstrates competence in technology skills required for this role, as well as ability to learn and master new skills.  
-Possesses the ability to listen and understand what others are saying in a diplomatic and neutral manner. 
-Establishes effective working relationships with others, contributing to a climate of mutual respect and cooperation. 
-Demonstrates sensitivity and tact, understanding own effect on the motivation, attitudes and actions of others. 
-Makes favorable first impressions.      
-Demonstrates full knowledge and understanding of concepts and procedures needed to be successful in the role, including knowledge of applicable department, organization and external rules and regulations impacting day to day processes. 
-Effectively manages people, resources, deliverables, budgets, general administration and other components of day-to-day management of functional unit or department.    
-Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums.  
-Position may require local travel between various Organization locations.   
 

Education:Required Education:
-Bachelor's degree required.
Preferred Education:
-Master's degree preferred.
-Project Management Professional (PMP).
-SOCRA or ACRP certification.
 
Clinical Research Start-Up Coordinator– Direct Hire

• Must have Bachelor’s Degree
• Must have 3-5 yrs Clinical Research exp
• Must have previous experience with start-ups
• Must have completed 30-50 trails

Will interface and communicate start-up details to the sponsor
Will support legal and contracts
Will help process timelines
Will work closely with the Clinical Research Activation RN
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 Onsite role