Clinical Research Associate I

Upstate University Hospital - Syracuse, NY

Full-time

Syracuse, NY

About the position

The Project Manager will oversee a large multi-site clinical trial, acting as the Coordination Center while managing all aspects of the trial at the Sponsor Level. This includes procurement of study drugs, site selection, vendor management, and regulatory communication. The role requires strong organizational skills and the ability to manage both high-level project goals and detailed operational tasks.

Responsibilities

• Coordinate all aspects of the clinical trial at the Sponsor Level.
• Procure study drug and manage site selection.
• Select and manage vendors for the trial.
• Develop consent forms and study documents.
• Oversee study and data monitoring activities.
• Report and manage Serious Adverse Events (SAE) and protocol deviations.
• Communicate and report periodically to regulatory agencies and financial sponsors.
• Secure and track all regulatory and financial documents from all sites.
• Schedule meetings and write necessary documents.
• Review documents and design Case Report Forms (CRFs).
• Answer site questions and identify vendors for drug supply and labs.
• Work with Institutional Review Boards (IRBs) and consult with biostatisticians.
• Develop study manuals for sites and the Coordination Center.
• Create workflows for SAE and protocol violations.
• Track study metrics and prepare reports for the Data Safety Monitoring Board (DSMB).
• Conduct study team meetings and schedule Steering Committee Meetings.
• Develop Standard Operating Procedures (SOPs) for the trial.

Requirements

• Bachelor's degree in a relevant field.
• Two years of related experience or an equivalent combination of education and experience.

Nice-to-haves

• Master's Degree or Doctorate Degree.