Under direct supervision of the Director of Clinical Operations, Manager of Clinical Operations and principal investigator, the CRC I is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
Responsibilities
Collaborates with study investigator in determining eligibility of potential participants in clinical trials
Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol
Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide participants' education regarding medication administration. Maintains investigational drug accountability, when needed, in cases where the Research Pharmacy is not maintaining that responsibility.
In collaboration with the study investigator, reviews study participants for changes in conditions adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
Responsible for accurate and timely data collection, documentation, entry, and reporting.
Schedules and participates in monitoring and auditing activities.
Maintains current and accurate documentation in the regulatory binder(s) as required by regulations and sponsors.
Participates in required training and education programs.
Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in the after-hours support and coverage schedule, if necessary.
Be at work and be on time.
Interacts in a positive and constructive manner.
Follows company policies, procedures and directives.
