Category

Description

Job Responsibilities

• Monitoring activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.
• Reviewing regulatory documents as required and prepare site visit reports.
• Participating in the study development and start-up process, including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training.
• Participating in clinical training programs and maintaining awareness of developments in the field of clinical research as needed.
  
  

Skills And Requirements

• A BS/BA degree.
• 2 years of monitoring experience or combination of on-site monitoring and clinical research coordinator experience.
• Sound knowledge of medical terminology and clinical monitoring processes.
• In-depth therapeutic and protocol knowledge as provided in company training.
• Ability to perform regionalized travel an average of 65%, depending on project needs.
• In depth therapeutic and protocol knowledge as provided in company training.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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