Clinical Trial Assistant

ID# DCNJ30499

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Working under the direction of the Trial Leaders, the Clinical Trial Assistant/Administrator is responsible for assisting the study team with activities related to the conduct of Medical Device Clinical Trials including preparation, distribution, tracking and filing of clinical trial documents. 

  •  Familiar with clinical trial development processes, clinical trial process and ICH-GCP, FDA and ISO 14155 Regulations
  • Ability to work in accordance with local Standard Operating Procedures (SOPs)
  • Ability to work in clinical planning and tracking systems, and learn new systems readily 
  • Strong computer skills in Microsoft Office Applications (Excel, MS Word, Outlook, PowerPoint) required
  • Great attention to accuracy and detail
  • Strong verbal communication and written skills to internal stakeholders and external customers -  Customer Focused 
  • Excellent organizational and tracking skills. 
  • Ability to collaborate with and support cross-functional teams, follow direction and work independently 
  • Proactive approach to job requirements and problem-solving
  • Ability to remain calm and composed when dealing with difficult people or situations
  • Ability to work efficiently in a high pressured environment with simultaneous demands 
  • Ability to prioritize work and meet timelines
  • Team orientated
  • Demonstrates a strong sense of responsibility and dedication
  • Excellent interpersonal skills including enthusiasm, positive attitude and flexibility contributing to teamwork spirit.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES

  • Provide administrative support to the Director, Project Managers and Clinical Research Associates. (25%)
  • Prepare essential clinical trial documents to distribute to the sites (study start-up), create and maintain clinical study contact lists for the study team and sites and manage clinical trial supplies under the supervision of the Clinical Project Manager or Research Associate. (25%)
  • Set-up, organize and maintain clinical study documentation Files (e.g. TMF) including preparation for internal /external audits, final reconciliation and archival. Includes; copying, routing, filing, etc. incoming correspondence, internal documentation, CRFs, safety reports, etc. and ensuring updated regulatory documents are on file for each site and study. (25%)
  • Assist the CRAs and Research Assistants in the reconciliation of study documents and contact clinical sites for specific requests (e.g. enrollment updates, missing documentation, outstanding queries, meeting arrangements, site visits, etc.) as applicable. (15%)
  • Assist the team with trial progress tracking (5%)
  • Attend project team meetings and generate meeting minutes (5%)
  • Perform other related duties as assigned by management. 

QUALIFICATIONS

  • Minimum education required for competent performance:

 Education:

  • College diploma in a health related discipline (e.g. R.N.) or Bachelors degree in life science/healthcare

 Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

  • Minimum of one year experience in monitoring or coordination of Sponsor led clinical trials or an equivalent combination of education and related work experience.

Position Details:

Medical Device

Clinical Research

Start Date: 
3-10-2014
End Date: 
2-9-2015

SANTA BARBARA, CA

Full Time

40

DCNJ30499

No

No