Ramses Davila

Clinical Research Coordinator @Indago Research & Health Center, Inc

US

Review study protocols and complete study training.· Attends I.M, S.I.V, and any other training session required by the Sponsor.· Meets with the Regulatory Department to ensure that the study is captured correctly in the system, including the window period between study visits, and verifies that the patient stipend reflects the same amount as in the ICF.· Reviews and maintains each tab of the Regulatory Binder.· Consents study participants following the Site’s SOPs.· If data entry personnel are not available, the CRC must enter the subject’s data in EDC within 24 hours of the visit being.· Ensures all deviations, violations, AEs, and SAEs are captured, recorded, followed, and reported to Sponsor/IRB promptly.· Performs study-related procedures in compliance with protocols and the Site’s SOPs.· Target enrollment goals and maintain close communication with the study subjects to keep them engaged in the trial while trying to achieve a higher retention rate.· Ensures that the Laboratory follows protocol requirements and that all samples are successfully packed and sent to the Central/Local Laboratory, as indicated.· Ensures proper follow-up through telephone contacts or certified letters when subject and emergency contact are not responding, continuing following up with subjects that have missed their appointments until they come back for their visit or are declared LTFU.· Confirm with the Front desk personnel, Laboratory technicians, and Assistant CRC, subjects scheduled for the following day.· Assists Clinical Research Associates or Auditors during on-site or remote monitoring visits, answering any queries generated and resolving pending action items within 7 days of the monitoring visit.· Maintains PI/Sub-I/Lead CRC always informed on all aspects of the trial.· Completes additional tasks as required by a specific protocol.· This position reports to the Team Lead Clinical Research Coordinator.