job title: senior clinical research associate(navitas)

Job Description

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