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

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