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In-House Clinical Research Associate

In-House Clinical Research Associate

ID 
2018-1395
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The In-House CRA role is a core member of the project team. This position will work with the project manager, Lead CRA and travelling CRAs on a clinical trial to ensure that monitoring activities are properly supported and that critical documents are being tracked, collected, and reviewed.  This position will also be responsible for managing data entered into the clinical trials management system (CTMS) and other project tracking tools. 

The In-House CRA will be responsible for assisting CRAs on query resolution and data reviews to ensure that studies operate in compliance with study protocols, Rho SOPs, ICH/GCP guidelines, and Federal Regulations. They will also be responsible for mentoring other team members.

Responsibilities

  • Collect, track and review investigational site records relating to subject screening and enrollment
  • Assist in the development of study plans and status reports
  • Collect, track, and review all site regulatory documents
  • Assist with development and review of Informed Consent Forms
  • Interact with sites, clients, vendors and internal study team members
  • Maintain the clinical trials management system (CTMS) and other project tracking tools
  • Track study supplies and coordinate shipments of supplies to sites as needed
  • Manage the study Trial Master File (TMF) and ensure periodic TMF audits
  • Will coordinate work with CRAs monitoring on-site
  • Perform on site co-monitoring and remote monitoring activities
  • Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines 

Qualifications

  • BA/BS, preferably in a life science, nursing, pharmacy or related field
  • 2 years of direct work experience managing essential documents within the CRO, pharmaceutical, or biotechnology industry
  • Attention to detail, excellent written and oral communications
  • Ability to set priorities and work independently
  • Proficiency with office automation software including Microsoft Office and Adobe Acrobat and strong internet research skills
  • Excellent organizational and multi-tasking skills
  • Working knowledge of ICH E6, and the Code of Federal Regulations
  • Strong written and verbal communication skills
  • The ability to constructively interact directly with sponsor personnel
  • Ability to travel as needed

EOE.Veterans/Disabled