CRA phase I

Reference: HAR-15-037

Client

Our client is a global top 10 pharma company located at the east side of Antwerp.

Studies are phase I studies.

This function is office based.

Main purpose

The CRA is responsible for the proper conduct of the study according to protocol, ICH-GCP and all applicable requirements

Tasks

  • Manage phase I trials ensuring compliance with protocol, Company SOPs, ICH-GCP and national regulatory requirements, local patient recruitment targets and financial agreements
  • Perform all trial-specific duties and activities assigned according to the current list of roles and responsibilities
  • Ensure accuracy, validity and completeness of data collected at investigational sites that meet clinical objectives and protect patient safety
  • Primary local company contact point for investigational site, monitoring and managing site activities on a daily basis
  • Prepare and submit Visit Reports punctually to Local Trial Manager for review
  • Report directly to a functional manager
  • Perform and coordinate ongoing trial-specific training for investigational site staff
  • Assist in training of company staff as required
  • Works closely together with the LTM/PM and CTAs at the local level Profile

Requirements

  • Medical, para-medical or other biologically related scientific education at university level.
  • Experience and proficiency in the conduct of clinical trials, preferably phase I trials
  • Ability to manage and support the activities of the investigational site staff and to contribute to the local┬átrial team
  • Have a good command of spoken and written Dutch, French and English, cultivate excellent relations with investigational site staff and be a proactive, enthusiastic member of the local Clinical Trials team
  • Ability to organize multiple priorities and projects within area of responsibility
  • Understand and use a range of computer-based systems to track, monitor and report on investigational site activity and status
  • Ability to anticipate and resolve investigational site-related problems
  • Willingness to travel with occasional overnight stay away from home

Apply for this position