Harvey Rosales
Mission,CA
Summary
Hard-working Site Manager with 8+ years of experience in the field with the necessary knowledge to run a functional research facility. Involved in over 100+ studies Phase 1 -Phase 4 (IP, device, and ePRO) Studies of the following specialties: Gastroenterology, Family medicine, Pulmonology, Ophthalmology, Nephrology, Cardiology, and Infectious Disease.
Overview
8
8
years of professional experience
Work History
Research Site Manager
Amicis Research Center
03.2020 - 04.2023
- Ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on timely basis
- To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards
- Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations
- Oversaw all daily office operations and equipment maintenance.
- Ensuring clinical trial management from SSV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents
- Management of several sites and PI Oversight for studies
- Worked with team to oversee company objective such as study metrics in 3 sites each having 10+ Studies
Lead Clinical Research Coordinator
Valley Renal Medical Group
01.2015 - 01.2020
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Managed 12 studies as lead coordinator at all times with average of 10+ patients
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Education
Bachelor of Science - Biology
California State University of Northridge
Northridge 01.2019
Skills
- Patient Recruitment, Obtaining Studies, and Obtaining Doctors for studies
- SOP Development and experience in creating clinical sites
- Facility Oversight
- Involved in over 100 studies Phase 1 -Phase 4 (IP, device, and ePRO) Studies of following specialties: Gastroenterology, Family medicine, Pulmonology, Ophthalmology, Nephrology, Cardiology, and Infectious Disease
- Knowledgeable in start up (FQ and SSV), site activation (SIV), conduction of study, and close-out of study
- All necessary skills required in DoA including phlebotomy, IRT, EDC, and ECG
- Regulatory Management and experience with IRB
- Have experience FDA-audit and Sponsor Audit
- Clinical Research Coordinator Training
- Establishing communication with Sponsor and PI
- Case Report Form Designing
- Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
Timeline
Research Site Manager
Amicis Research Center
03.2020 - 04.2023
Lead Clinical Research Coordinator
Valley Renal Medical Group
01.2015 - 01.2020
Bachelor of Science - Biology
California State University of Northridge
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