Recruit and prescreen potential study participantsSchedule screening and visit appointments, coordinating with participant, site, CSC, and vendorsMaintain online recruitment communication systemAssist with data entry, systems reconciliation, and minimizing backlogRegister participant in system to receive reimbursement, process study visit paymentsAnswer, handle, direct incoming calls to study general lineParticipate in weekly team, lead, site meetings to align organizational goals and trial protocol operations

o ICH GCP E6 (R2)o FDA Regulations 21 CFR parts 11, 50, 54, 56o Clinical Trial Operations: feasibility to close outo Comprehension and Execution of Protocolo Recruitment, Retention, and the Informed Consent Processo Identifying and reporting AEs, SAEs, and protocol deviationso GCP according to ALCOA-C principleso Data Management Systemso Monitoring, Quality Assurance, Inspections, and Query Resolutiono Maintaining a regulatory binder housing essential documents including, but not limited to 1572, DOA, training logs, IRB approved documents, IP accountability forms, etc.

Responsible for coordinating and executing research studies according to trial specific protocolRecruited, consented, and educated study participantsPerformed ECG’s, Pulmonary Function Tests on research participants; collected vitals, labsCompleted source documents and case report forms; entered data in corresponding EDC systemsCollected, processed, and shipped lab specimensPrepared for and participated in study visits with monitors, sponsors, auditors, and other stakeholders

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