Sahdeo Prasad

Clinical Research Coordinator Iii @Masonic Cancer Center, University Of Minnesota

Minneapolis, MN, US

Responsible for trial initiation activity, regulatory approvals, study procedures and eCRF completion, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.• Provide independent, advanced clinical and operational management of five clinical studies, serving as a liaison to patients, clinicians, mid-level providers, clinic nurses, principal investigators, pharmaceutical companies, medical monitors, CROs, and clinical regulatory professionals.• Lead clinical study coordinator for multiple projects.• Responsible for completing regulatory forms (SAE forms, deviation, continuing review, informed consent forms, etc.) and complying with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.• Coordinator for global and multi-center trials, assisting clinic staff and research staff in providing administrative and patient care services.• Works closely with the Clinical Trial Manager (CTM) and/or CRAs to ensure all monitoring activities are conducted according to study requirements• Working experience with various clinical data management and reporting systems such as Medidata, Oncore, Florence, Clario, etc.• Provide clinical presentations and information during scientific research committee meetings and audits in response to unsolicited questions in healthcare provider settings in both group and one-on-one situations.• Responsible for clinical data analysis, prepare abstracts, posters, and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.