Sr. CRA 2, FSP - Invitro Diagnostics

Responsibilities

• Utilize skills, knowledge, and clinical judgement to provide high standard of care for participants in clinical trials and respond to emergency situations.
• 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; liaise with vendors; and other duties, as assigned.
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring
• Ensure study staff receive proper materials and instructions to safely enter patients into the study.
• Protect study patients by verifying informed consent procedures and protocol requirements are adhered to.
• Verify data integrity by reviewing source documents and CRFs.
• Report Serious Adverse Events (SAEs).
• Assist with training of new employees.
• Coordinate designated clinical projects.

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 4+ years of Clinical Monitoring experience
• 50-60% overnight travel