Erwin Espiritu, Msc Email & Phone Number

London, Gb

Contracted as Clinical Site Management Oversight to a UK-based Sponsor working in the field of personalized immunotherapy (CAR T) in the following indications:-Hematologic Malignancies -Solid TumorsOversees a team of 13 members and 7 direct reports.

London, Gb

Contracted Senior Clinical Site Manager to a UK-based Sponsor working in the field of personalized immunotherapy (CAR T) in the following indications:-Hematologic Malignancies -Solid Tumors

New York, Ny, Us

Provides clinical research consulting services to the pharmaceutical and biotech industries performing clinical vendor and CRO oversight on behalf of Sponsor companies ensuring adherence to federal regulations, guidance, and inspection readiness. Additional specialties in CAR T-cell therapeutics, monitoring and site management activities in accordance with applicable SOPs, guidelines, and study protocols.Extensive experience performing site selection, initiation, regular monitoring, and close-out visits for Phase I-IV clinical trials; working with pharmaceuticals, biologics, and medical devices. Collaborates with cross-functional teams to streamline processes and contribute to a company's overall success.Evolve Clinical Consulting, LLC is registered within the state of California.

Madison, Wisconsin, Us

Clinical research consultant to a US-based Sponsor allocated with national travel and have worked on the following indications, performing Clinical Monitoring Oversight of CRO and vendor activities.-Colorectal Cancer Screening-Lung Cancer Screening-Solid Tumor Screening-Hematologic Malignancy Screening

Cincinnati, Oh, Us

Clinical research consultant to a Global CRO allocated with national travel and have worked on the following indications:-Cutaneous T-Cell Lymphoma (CTCL)-Adult T-Cell Leukemia-Lymphoma (ATL)-Adenocarcinoma of the Pancreas

Flemington, Nj, Us

Contracted as a Senior Clinical Research Associate to a Global Oncology CRO allocated with regional travel and have worked on the following indications:-Advanced Solid Tumor

Durham, North Carolina, Us

As part of Quintiles' Global Functional Resourcing model, I served as a contracted partner for Amgen. I monitored the activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. I reviewed regulatory documents as required and prepared site monitoring visit reports. I was responsible for multiple projects and worked both independently and in a team environment. I reviewed CRFs, informed consent forms, issued/resolved queries and conducted routine monitoring activities per the monitoring guidelines. I was trained to monitor Oncology studies, as well as Early Development (ED) studies (including First in Human and Phase 1a/1b trials).In addition to regular monitoring activities I also served as a Lead CRA for various protocols and acted as a liaison for monitoring questions, as well as directly assisted the SaCOM/COM (Project Manager) with study related metrics and tasks. Previous Positions Held within Quintiles:-Senior Clinical Research Associate I / Lead CRA (October 2012-October 2013)-Clinical Research Associate II / Lead CRA (October 2011-October 2012)-Clinical Research Associate I (October 2010-October 2011)

I reviewed case report forms, resolved queries and tracked study specific data documents in accordance with relevant GCP/ICH guidelines; coordinated contact with potential sites and documented communications; tracked and reported all site recruitment efforts; collected, reviewed, and tracked all study specific regulatory documents; conducted informed consent review and coordinated with sites to ensure accurate documentation is received in a timely manner; and attended/participated in study and Paragon meetings.Previous Position Held within Paragon Biomedical:-Project Assistant (January 2008-October 2008)

Master Of Science, Clinical Research Administration

Bachelor Of Science, Pharmacology