Key responsibilities
- Coordinate Protocol Execution so Visits, Procedures, Consent, and Source Documentation Occur Within Study Windows and Good Clinical Practice Requirements.
- Maintain Inspection-ready Trial Records, Including Case Report Forms, Drug Accountability Logs, Regulatory Binders, Delegation Logs, and Progress Reports.
- Operate Enrollment Administration by Screening Candidate Records, Tracking Inclusion and Exclusion Criteria, Documenting Screen Failures, and Updating Sponsor Enrollment Dashboards.
- Manage EDC Data Entry and Query Resolution so Visit Data, Labs, Adverse Events, and Protocol Deviations Are Complete Before Monitoring Review or Database Lock.
- Administer Site Start-up and Close-out Workflows, Including Essential Document Collection, Training Evidence, IRB Submissions, Activation Checklists, and Archival Handoffs.
- Monitor Study Activity for Protocol Compliance, Escalate Deviations or Safety Events to Investigators, Sponsors, IRBs, and Oversight Agencies, and Document Corrective Actions.