Minimum of 2 years of experience as a Clinical Research Coordinator in a clinical trial setting.
Hands-on experience working on clinical trial phases I, II, and III, with understanding of protocol requirements across different phases.
Experience with pre-screening patients and conducting subject recruitment for clinical studies.
Demonstrated experience handling and documenting adverse events in accordance with regulatory and protocol requirements.
Ability to interpret and gather comprehensive medical histories from study participants.
Proficiency in performing and documenting vital signs and cardiograms (ECGs) as part of clinical research assessments.
Working knowledge of oncology clinical research processes, including consenting, regulatory requirements, and IRB procedures.
Strong skills in data entry, data abstraction, and database management, with attention to accuracy and completeness.
Familiarity with FDA Good Clinical Practice (GCP) standards and local and state regulations related to clinical research.
Ability to manage multiple concurrent trials and organize workload to support 57 studies and 34 patient visits per day.
Experience performing cardiograms (ECGs) in a clinical or research environment.
Knowledge of regulatory processes and IRB submissions related to oncology trials.