Perform quality assurance activities for the research studies, including but not limited to, protocol deviations, study file maintenance, and documentation of adverse events.
Ensure compliance with protocol, SOPs, GCPs, and FDA regulations. Perform clinical monitoring of all subjects in accordance with GCP and ICH guidelines.
Act as liaison between the Principal investigator and the sponsor to ensure that all study implementation and protocol requirements are met.
Assist with the collection of study recruitment materials for the hospital. Participate in the recruitment of potential subjects. Review and approve informed consent.
Coordinate and conduct pre-study, initiation, interim, and close out visits. Ensure that all clinical trials are carried out according to protocol, including but not limited to, source document verification, subject recruitment
Assist with the collection of study related documents, including but not limited to, informed consent, source document, and clinical trial materials.
Clinical Research Coordinator
Electronic Data Systems
Assisted in the development and implementation of quality assurance and monitoring activities for the study and medical logistics. Conducted site visits, including: consenting, consent forms, and enrollment.
Research subjects for study visits, IV and SC, IM, SC, ID, and investigational drug. Clinical trial management.
Coordinate study visits, schedule appointments, audit operations, and other research related documents. Manage study logistics. Collect and process specimens.
Notifies supervisor of any adverse events or serious adverse events. Ensures that all study related documents are complete and accurate.
Manage study start-up activities, including: recruitment, participant consent, and drug accountability. Reconciliation of investigational drugs.
Ordering and maintaining investigational drug inventory for all trials. Maintain accurate and complete records of study activity. Assist with the preparation of IRB submissions.