Clinical Research Associate

Responsibilities: 

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits following company SOPs and in accordance with GCP
• Responsible for all aspects of site management as prescribed in the project plans
• Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used
• Undertake feasibility work when requested
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as delegated
• Negotiate study budgets with potential investigators and organize contract agreements
• Independently perform CRF review; query generation and resolution against established data review guidelines
• Act as a local client contact as assigned and perform other project management as delegated

Requirements:

• 1-2 years relevant experience in a Clinical Research environment:

o   Providing clinical support for projects according to company SOPs, ICH Guidelines and GCP

o   Submission of clinical research projects applications, serious adverse events and progress reports to CIRB and regulatory agencies

• Good planning, organization and problem solving abilities
• Good communication and interpersonal skills
• Computer competency