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.
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