We are currently seeking a Senior Clinical Research Associate to join our growing team

The role will include the following:

Working in accordance with ICH E6 principles and with applicable SOPs
Conduct of Feasibility assessments
Project set up activities
Conduct of site selection activities
Negotiation and facilitating Investigator/site contract execution
Development and local adaption of study specific documentation
Set up of the trial master file
Project conduct
Maintenance of TMF
Facilitating Regulatory submission
Prepare, conduct and participate in Investigator s meeting
Conduct Site initiation and site monitoring
Maintain communication with study teams at site
Maintain communication with clients and vendors as back-up for a project manager/project team lead based on the requirements
Resolution of site level issues and where necessary escalation of issues to PM
Support PM/PTL with project updates
Participate in client meetings/teleconferences and inter-departmental meetings
CRF retrieval and Query turnaround
Project closeout
Conduct site closeout visits

Desirable Skills and Experience

A minimum of 3 years monitoring experience
Strong knowledge of GCP principles and related local regulations

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