About this role
About the Role Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning. What You'll Do
- Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
- Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data;
- Attend all relevant study meetings;
- Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research;
- Recruit and screen patients for clinical trials and maintain subject screening logs;
- Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits;
- Design and maintain source documentation based on protocol requirements;
- Schedule and execute study visits and perform study procedures;
- Collect, record and maintain research subject data.