Sr CRA I - client-dedicated at Syneos Health Clinical Solutions

Job Details

• Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:

Overview the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
Ensure quality of data submitted from study sites and assures timely submission of data. Train study site personnel on the protocol and applicable regulatory requirements.

• Facilitate Quality Assurance Audit processes as indicated.
• Report monitoring activities and study site conduct accurately and completely.
• Prepare CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable.
• Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
• Negotiate investigator/ hospital agreements with stakeholders.
• Use multiple technologies to maintain open and frequent communication with internal & external customers.

Requirements
The ideal candidate will need the following experience / skills to be considered:

• Minimum of 3-4 years of clinical monitoring.
• Start-up experience will be asset.
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Good written and verbal communication skills. Written and verbal fluency in English.
• Previous experience with electronic data capture systems is desirable.