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Clinical Trial Associate

4 months ago

Walnut Creek, United States Neurocentria, Inc. Full time

The Clinical Trial Associate (CTA) is responsible for the management of the clinical trial documents, review of the site file document, assisting with the planning and development of the study documents, and oversight of clinical trial documents while ensuring the trial documents are managed in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable SOPs/Work Instructions. 


Responsibilities

Study Planning and Conduct:  

  • Set up eTMF system, as appropriate  
  • Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations 
  • Handle incoming and outgoing shipments, as needed 
  • Assist with all aspects of initial study drug release including regulatory packet review and study-drug release 
  • Assist in the preparation of study-specific training materials 
  • Participate in the planning of investigator meetings  
  • Assist in the development of case report forms and participate in the EDC and IVRS specification process, as appropriate  
  • File clinical documents and maintain clinical research files (i.e., central files for studies) 
  • Participate in support of regional Field Monitors 
  • Interact with sites as needed to respond to issues 
  • Monitor and track ALL monitoring visit reports (in SharePoint and eTMF) 
  • Responsible for tracking of clinical trial progress including status update reports, as required 
  • Participate in the review of clinical data at the case report form, data listing, and report table levels 
  • Assist with final sign off  of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, IND Annual Updates, NDAs, and other documents, as required 
  • Participate in clinical teams, including attending required meeting, and interact in a positive, professional manner. 
  • Maintain training update to date including review and sign off all SOPs 
  • Identify and escalate issues appropriately. 
  • Set up clinical trials in ‘Clinicaltrial.gov’ and maintain until end-of-study 
  • Support study team in IRB submission and updates 
  • Manage study meeting calendar 
  • Draft study meeting agendas and take study meeting minutes
  • Maintains completion of required corporate training on standards, policies, work instructions by due date 
  • Performs other work-related duties as assigned


Qualifications

  • A bachelor's degree in biology, life sciences, health sciences, healthcare administration, psychology or business.
  • At least 1-2 years of experience working in clinical trials, medical research, or a CRO.
  • Familiarity with Good Clinical Practice (GCP) guidelines and Institutional Review Board (IRB) is essential.
  • Understanding of relevant regulatory agencies like the FDA is preferred.
  • Strong organizational skills and meticulous attention to details.
  • Excellent communication skills, both written and verbal.


What we look for in our people

  • Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development
  • Desire to work in a quickly changing and fast-paced growing business
  • Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done
  • Ability to overcome ambiguity and challenge the status quo
  • Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently
  • Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders


As an equal opportunity employer, Neurocentria is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.