Clinical Study Monitor

Job summary
Element is seeking a Clinical Study Monitor to join our team in Colorado.The monitor will assist the Quality Manager in reviewing clinical studies and ensuring protocol requirements are met.This is a hourly-paid position with pay range of $25.00-$40.00 per hour.
Job seniority: entry level
Responsibilities
• Review completed clinical studies and ensure all necessary paperwork is included in study binders.• Follow organizational guidelines and standard operating procedures.• Review and complete submission forms required by the IRB.• Oversee the progress of clinical trials and ensure they are conducted in accordance with protocols, SOPs, and GCP.• Monitor study documentation and confirm informed consent process is used.• Identify missing documents in research study binder and generate regulatory documentation based on ISO14155.• Assist with GLP Quality Audits and Lab organization and training.• Maintain compliance on CITI training, Blood Borne Pathogen compliance, and DORA licensure requirements.• Interface with sponsors and study coordinators for monitoring.• Assist with generation of Monitoring procedures.
Requirements
• Degree preferred.• Proficiency in Microsoft Applications.• Availability, flexibility, and maturity to represent the company at various events/projects.• Well-developed oral and written communication skills.• Good interpersonal skills that foster open communication.• Technical background is a plus.• Ability to interface with clients and attention to detail.
Key Skills Needed
• Degree preferred• Microsoft Applications proficiency• Oral and written communication skills• Interpersonal skills• Attention to detail