March 7, 2017

Duration : permanent position

Contact name : Sara Weytjens

Phone number :

Email : This email address is being protected from spambots. You need JavaScript enabled to view it.

Description

Support the Clinical Operations Manager with the day-to-day functional and organizational activities of Clinical Research Associate (CRA) management.

  • Assists the Clinical Operations Manager in resourcing CRAs and/or Project Managers (PM).
  • Provides leadership, mentorship and career development for the assigned staff, including monitoring performance and identifying training needs.
  • Oversees and manages the assigned CRA workload.
  • Assist CRAs in managing time and tasks to adhere to study budget and timelines.
  • Provide guidance to ensure that staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
  • Liaises with project management to ensure CRAs are fulfilling monitoring requirements and meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and CRA or LCRA/CTL project team member transition meetings.
  • Reviews the budgeted and recorded hours to ensure they are within acceptable working limits for active studies for the assigned CRAs.
  • Participates in the interviews of candidates and hiring of new CRAs.
  • Performs co-monitoring and monitoring duties as required.
  • Plans and executes CRA training meetings, as well as contributes to and delivers CRA training curriculum.
  • Contributes to the process improvement initiatives.
  • Conducts CRA assessment visits.