Senior Research Project Coordinator

Job Summary

As an important member of the research team, the Clinical Research SURVENT Project Coordinator works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. The Project Coordinator communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all. This position is responsible for the implementation and coordination of clinical trials and investigator-initiated studies conducted by Dr. Sachin Wani and colleagues at the University of Colorado.

Key Responsibilities

• Assist with and oversee the day-to-day operations of clinical trials and studies.
• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines.
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies.
• Coordinate and track regulatory submissions and documentation, including site regulatory packets, amendments, and required study updates.
• Assist with the preparation and execution of subcontracts and site agreements in collaboration with institutional administrative offices. Process and track site invoices and payments to ensure timely reimbursement to participating sites.
• Organize and coordinate a multi-site in-person investigator meeting, including agenda development, logistics, and communication with participating investigators and stakeholders.