Managed and maintained a high level of patient confidentiality and compliance with all aspects of the study including but not limited to: Protocol adherence, IRB submissions, IRB submissions, and adverse event reporting.
Managed the logistics of the study, including regulatory document review, informed consent, medical records, safety data sheet, and drug accountability.
Performed quality assurance inspections of all study related documents, including but not limited to: Site administration, budget, and adverse event reports.
Coordinated and conducted study visits, including but not limited to, protocol adherence, study initiation, drug accountability, adverse event reporting, and drug accountability.
Coordinated with the sponsor, IRB, and research staff to ensure compliance with FDA regulations, study protocol, and database maintenance.
Assisted in the development of study protocols, informed consent forms, case report forms, and other study related documents.
Clinical Research Nurse Coordinator
Organized patient retention, safety, and adverse event reporting. Responsible for all aspects of study initiation, including: Protocol adherence, SAE reconciliation, and drug accountability.
Performed administrative duties including but not limited to, reconciliation of all clinical data, and organization of safety. Ensure compliance with all federal and state regulations.
Ensured all data collection and submission, including but not limited to, the following: Case report forms, source documents, case report forms, and other study related materials.
Conducted administration of study drug, drug accountability, data collection, and ordering of investigational products. Maintained and updated electronic medical records.
Completed data entry, query resolution, and maintenance of study documents including source document verification, drug accountability, and adverse event reports.
Research and referrals for study participants, including informed consent process, case report forms, and source documents. Reconcile and track adverse events and drug events.