About the job

Responsibilities

• Key duties include but not limited to:Responsible for the integrity and overall quality of assigned clinical research trials
• Serves as the primary contact for study subjects and sponsors, communicating daily as needed.
• Reviews study protocols and brochures; creates study document binder and prepares source documents including study and subject information folders.
• Attend sponsor meeting as needed for assigned protocols.
• Oversee sponsor database process.
• Completes study procedures including:
• Pre-screening, screening, and study visits in conjunction with Physician/Investigator (may include vital signs, performing EKG’s, phlebotomy, processing specimens and shipping to labs).
• Documentation of patient progress in response to investigative agents.
• Coordination of monitor visits with patients.
• Completion of source documents and case report forms.
• Oversee preparation of physician orders to ensure protocol compliance as needed.
• Maintain communication with physician regarding study requirements, dose modifications, and adverse events.
• Upkeeps all trial regulator documentation.
• Maintain high level of understanding of the ICH/GCP guidelines.
• Perform other related duties as assigned