March 7, 2017
Duration : permanent position
Contact name : Sara Weytjens
Phone number :
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.