Jonathan Wu, Mph, Ms Email & Phone Number

• Oversee clinical trials conducted in North America (US and Canada)• Ensure clinical trials enroll a diverse patient population based on FDA's guidance to improve enrollment of participants from underrepresented racial and ethnic populations

Orange County, California, United States

• Oversee performance for the lifecycle of clinical trials (start-up, maintenance, close-out, database lock).• Currently leading 3 clinical trials and teams with 50 sites in the United States and Canada.• Drive clinical trial from initiation to completion while ensuring patient safety, high quality data, and all deliverables are reached for submission to regulatory authorities.• Collaborate with Senior Leaders to design and implement innovation/improvement initiatives from start to completion, including change management.• Lead trial meetings and ensure members of the trial team are delegated and trained on responsible tasks.• Identify risks to trial delivery and contribute to mitigation development and deployment.• Active coaching, mentorship, and training of stakeholders to build insight and talent.• Support, prepare for, and follow-up on audits and inspections.• Collaborate and provide input and guidance to department and global partners.• Drive subject recruitment and retention by supporting sites and patients.• Coordinate and drive site selection and start-up/activation activities including Site Selection Visit and Site Initiation Visit through development of training materials and tools.• Review and approve visit reports while confirming subject safety is documented and issues are escalated.• Develop site communication including key updates and important information regarding patient safety.• Identify safety trends by analyzing reports to ensure proper follow up and issues are prevented/resolved.

Orange County, California Area

• Oversaw and managed all operational aspects of Clinical Trials (Phases I-IV) while ensuring reliable quality data is delivered and GCP and SOPs are met.• Performed Site Selection, Site Initiation, Routine Monitoring, and Closeout Visits at various sites and complete high-quality visit reports within timelines.• Worked directly with Trial Managers and Clinical Study Leads as a Liaison while completing many TM and CSL tasks.• Served as 1 of 4 CRAs in the US to lead as Liaisons by working with Trial Managers to review and develop Clinical Monitoring Plans and eCRF Completion Guidelines.• Served as a Business Process Expert on the Study Start Up Optimization Group to ensure site activation process is more streamlined so more sites can be activated by First Patient First Visit.• Selected by Senior Leadership Team as 1 of 20 out of over 5000 employees in the US to lead own region to develop and finalize site feasibility questionnaires from initiation to finalization.• Developed multiple tools to assist all CRAs with being more efficient with tracking trial documents to ensure TMF compliance throughout trials while reducing time spent on site.• Proactively manage study level recruitment and retention by working with sites to develop plans to reach recruitment goals in reduced amount of time and to retain subjects in trials.• Provided input for study materials including Clinical Monitoring Plans and eCRF Completion Guidelines.• Ensure deep understanding of Protocol and advanced knowledge of Good Clinical Practices.• Ensured monitoring reports are of high quality and any protocol deviations are captured appropriately.• Accountable for data integrity, patient safety, and regulatory compliance for assigned sites.• Maintained Investigator Trial Files throughout the trials in accordance with SOPs.• Performed on-site drug accountability, reconciliation, and return while ensuring trial product storage meets Protocol and SOP requirements.

Orange County, California, United States

• Conduct regular monitoring visits (PSV, SIV, SMV, COV) in accordance with company site monitoring SOP/Sponsor site monitoring SOP/WP.• Oversee conduct of clinical trial sites and ensuring that they are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH/GCP and regulatory requirements.• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.• Ensure Investigational Products (IPs) are supplied only to eligible patients and returned appropriately.• Ensure disposition of used or unused IP comply with regulatory requirement and are in accordance with the Sponsor.• Ensure informed consents for each subject are documented appropriately to protect the rights, safety and well-being of each human study subject.• Ensure that all adverse events are correctly documented and that any serious adverse events are reported to the Sponsor within 24 hours and reported to the IRB.

Orange, California

- Collect data and run analysis on SAS for a clinical improvement research project on palliative care in the intensive care unit. - Discovered that a proactive intervention to palliative care helps identify patients who may benefit most from palliative care and leads to patients receiving a consultation 33% sooner. - Recruit heart failure patients to a clinical research project to see if a combination clinic of cardiology service and palliative care service will lead to an improvement in the quality of life, symptom burden, and psychosocial outcomes.- Consent, screen and qualitatively interview patients to ensure the appropriate patients are enrolled in the research study while being IRB compliant.- Authored a systematic review on the association between antiretroviral therapy (ART) use and congenital anomalies in infants born to HIV-infected pregnant women - will be published.

Boston, Massachusetts

- Visited elderly patients from low-income communities and disadvantaged backgrounds weekly during their stay at the hospital.- Improved the quality of life and reduced the burden of hospitalized patients by providing comfort and emotional support.

Orange, California

Designed and submitted IRB approved protocol. Collected data on the practice of stethoscope hygiene at an academic hospital and suggested an intervention for preventative action.Recognized the low stethoscope hygiene rates, authored an abstract sent to the Society of Hospital Medicine, and presented a poster at the annual meeting to increase awareness of stethoscope hygiene to clinicians.Authored a research abstract which was accepted by the Society of Hospital Medicine.Presented at the Society of Hospital Medicine Annual Conference in Las Vegas, Nevada, in order to educate and increase awareness of the importance of stethoscope hygiene to clinicians and the community.

Boston, Massachusetts

Tutored incoming MPH students the required core courses and provided a better understanding of the material by thoroughly explaining the concepts of each class.

Laguna Beach, California

Shadowed the plastic surgeon while in the operating room.Assisted the plastic surgeon in publishing journal articles on new findings in an effective and efficient manner.

Costa Mesa, Ca

Provided assistance to a professor in a General Chemistry Laboratory class of 28 undergraduates. Assisted students with assignments and various questions about chemistry lectures and experiments, effectively adding creative input to lesson plans.

Orange, California

Conducted on-site interviews with elderly patients with dementia and multiple sclerosis to study the physical, psychological, and emotional relationship between patients and their caregivers to improve quality of life.Contributed and attended monthly LEAD panel (Longitudinal, Experts, All Data) meetings with geriatricians and public health workers at the forensic center and provided input from the collected data from patient visits.Assisted in completing various projects assigned by the principal investigator.

Orange, California

Restocked materials for doctors and nurses while filing patient applications confidentially.Provided moral and emotional support to patients during difficult situations of high-stress. Helped transfer patients to different departments, while providing assistance to technicians working in surgical rooms.

Doctor Of Public Health (Drph), Public Health

Master Of Science (M.S.), Medical Science

Master Of Public Health (M.P.H.), Epidemiology

Bachelor Of Science (B.S.), Biological Sciences

Activities and Societies: Sigma Phi Epsilon Fraternity, Anteater's Habitat for Humanity

Physics

Study Abroad Brighton, United Kingdom

Doctor'S Degree, Public Health