Sharon Desario
Orange,CA
Summary
Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Clinical Trials Unit Operations Manager
UCSD - Neurosciences|Shiley-Marcos Alzheimer's Disease Research Center
01.2023 - Current
- X Supervising a staff of 9, ensuring thorough training and confidence in their work x Collaborates with Principal Investigators and team to manage expectations and goals x Delegates and monitors team's tasks to increase work flow x Manages and oversee day-to-day activities of operations, including planning and coordination with other units x Building an effective team of workers that increase sponsor satisfaction by setting values of quality and acknowledging and rewarding employees for outstanding work and challenges conquered x Improving operational effectiveness by streamlining business operational work processes and procedures
Senior Regulatory Coordinator
UC Irvine Health - UCI Center for Clinical Research
04.2020 - 01.2023
- Provides comprehensive regulatory management of clinical trial protocols in accordance with human subject federal regulations, internal SOPs, policies and procedures
- Coordinates with the IRB and ancillary committees within UCI; liaison for the FDA, sponsors and other external entities.
Senior Research Coordinator
UC Irvine Health - Department of Medicine, Division of Gastroenterology H.H. Chao Comprehensive Digestive Disease Center
08.2019 - 04.2020
- Work on all phases of drug studies and device studies for both sponsor and Pl studies
- Main contact for Sponsor/CROs, faculty and hospital administration
- Prepare IRB submission paperwork (consent form, research plan, and other internal documents) for local and central IRBs
- Prepare regulatory documents for sponsor (1572 form, FDFs, CVs, medical licenses, certificates, etc.)
- Prepare budgets for sponsor negotiations
- Prepare IRB renewal and amendments
- Prepare close-out forms
- Prepare invoices and sends to the sponsor
- Interview and screen potential subjects
- Conduct subject visits
- Enter data onto CRFs or eCRFs
Project Manager
UCSD San Diego - Altman Clinical & Translational Research Institute {ACTRI)
01.2016 - 07.2019
- Oversees over 30 research projects for multiple PIs for multiple indications
- Work on all phases of drug studies and device studies for both sponsor and Pl studies
- Main contact for Sponsor/CROs, faculty and hospital administration
- Conducts all Site Qualification Visits
- Prepare IRB submission paperwork (consent form, research plan, and other internal documents) for local and central IRBs
- Prepare regulatory documents for sponsor (1572 form, FDFs, CVs, medical licenses, certificates, etc.)
- Prepare budgets for sponsor negotiations
- Prepare IRB renewal and amendments
- Prepare close-out forms
- Prepare invoices and sends to the sponsor
Regulatory Coordinator and Study Coordinator
UCSD San Diego - Clinical and Translational Research Institute
12.2014 - 01.2016
- Prepare, coordinate and process study documents for all phase of studies per the University, federal and state requirements
- Key contact person for pharmaceutical companies, Contract Research Organizations, and Site Management Organizations
- Oversees and Coordinates study set-up visits
- Interact with HRPP (IRB), OCTA/OCGA, OCAA, Research Compliance, FDA, WIRB, Study Sponsor, Pharmacy and other entities as required
- Coordinate and participate in study site initiation visits
- Create and maintain study regulatory files
- Prepare and participate in study audits, including Sponsor, QA, and FDA audits
- Provide reports to the study doctors (i.e
- Number of subjects by study, potential subjects, screen failures, budget information etc.)
- Maintain Pl/Study Coordinator communication relationships
- Create Case Report Forms (CRFs) for Pl initiated studies
- Create Source Documents for Studies
- Performed as Study Monitor for Pl initiated clinical trials
- Create and maintain complete and accurate charts
- Complete and record study data as per sponsor guidelines
- Obtain protocol specific information from subjects
- Conduct scheduled study visits with study subjects as per the protocol
- Perform nurse's duties such as injections, vital signs, blood draws, insert heplocks, start IVs, and EKGs
- Interview and screen potential subjects
- Enter data onto CRFs or eCRFs
Supervisor for CTRI Study Coordinators
UC San Diego - Clinical and Translational Research Institute
12.2011 - 12.2014
- Responsible for 5 Study Coordinators
- Provided leadership and direction
- Conducted performance evaluations
- Trained new coordinators
- Conduct weekly staff meetings
- Assigned work tasks for multiple coordinators
- Collaborate effectively with Principal Investigators to carry out studies in various stages of development, maintenance, and closeout
- Facilitate various project meetings and conference calls and contribute original ideas
- Responsible for evaluating business needs, analyzing resources, prioritizing workload, allocating resources to ensure appropriate assignment and fair distribution of workload, and for developing innovative solutions to improve monitoring processes
- Ability to create control systems to identify areas for improvement, and control unforeseen problems
- Strong decision-making skills and ability to use independent judgment to quickly set priorities, solve problems and resolve conflict
- Ability to respond effectively to unexpected events and crises
- Back-up study coordinators and help perform protocol visits when needed
- Perform regulatory duties - submit new protocols, submit protocol amendments, submit annual renewals
- Interact with sponsors for starting up new studies, help the monitor during their visits, and complete queries
Education
License Vocational Nurse - Biology
Concord Career Institute
North Hollywood, CA05.1995
Skills
- Meticulous and detail oriented professional with an eye for accuracy
- Solutions oriented and strong analytical thinking
- Able to work well in a team, contributing ideas and cooperating with others to achieve common goals
- Quick to embrace challenges and changes in priority, providing significant results and high levels of accuracy
- An effective written and verbal communicator, with the ability to convey information clearly and concisely
- Strong focus on efficiency optimization, consistently meeting deadline
- Proven ability to foster a collaborative team environment, driving efficiency and productivity
Certification
Certified Clinical Research Coordinator (CCRC)
Affiliations
Society of Clinical Research Associates (SOCRA)
Personal Information
Title: LVN, CCRC
Timeline
Clinical Trials Unit Operations Manager
UCSD - Neurosciences|Shiley-Marcos Alzheimer's Disease Research Center
01.2023 - Current
Senior Regulatory Coordinator
UC Irvine Health - UCI Center for Clinical Research
04.2020 - 01.2023
Senior Research Coordinator
UC Irvine Health - Department of Medicine, Division of Gastroenterology H.H. Chao Comprehensive Digestive Disease Center
08.2019 - 04.2020
Project Manager
UCSD San Diego - Altman Clinical & Translational Research Institute {ACTRI)
01.2016 - 07.2019
Regulatory Coordinator and Study Coordinator
UCSD San Diego - Clinical and Translational Research Institute
12.2014 - 01.2016
Supervisor for CTRI Study Coordinators
UC San Diego - Clinical and Translational Research Institute
12.2011 - 12.2014
License Vocational Nurse - Biology
Concord Career Institute
Certified Clinical Research Coordinator (CCRC)
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