Experience

Alto Neuroscience

• United States
• Biotechnology
• 1 - 100 Employee

• Clinical Trial Manager

  • Sep 2022 - Present

• Clinical Research Associate

  • Jan 2022 - Present



Masimo

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Clinical Research Associate II

  • Dec 2019 - Jan 2022

  Irvine, California Plan, implement and conclude clinical studies in support of project timelines/market release goals. Contribute to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects. Prepare and document study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across… Show more Plan, implement and conclude clinical studies in support of project timelines/market release goals. Contribute to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects. Prepare and document study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects. Conduct site monitoring (qualification, initiation, monitoring and close out visits) to ensure sites are trained and follow study procedures per the protocol. Monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations. Operate Masimo products and data acquisition systems following best practices for execution of study protocol and use of equipment. Ensure essential study documents are properly organized and stored as quality records. Conduct basic data analysis. Prepare clear, succinct and detailed clinical study and technical summary reports. Show less



UC Irvine

• United States
• Higher Education
• 700 & Above Employee

• Clinical Research Coordinator, UCLA-UCI Alpha Stem Cell Clinic

  • Feb 2018 - Dec 2019

  Irvine, CA Provide comprehensive coordination for multiple Phase 0-III cell therapy and medical device clinical trials according to study protocols, institutional policy, and federal regulations relating to Good Clinical Practices (GCP). Manage all study start-up activities: prepare and negotiate clinical trial budgets, prepare and submit all applications and regulatory documents to the Institutional Review Board (IRB) and ancillary committees. Coordinate and attend study monitoring visits… Show more Provide comprehensive coordination for multiple Phase 0-III cell therapy and medical device clinical trials according to study protocols, institutional policy, and federal regulations relating to Good Clinical Practices (GCP). Manage all study start-up activities: prepare and negotiate clinical trial budgets, prepare and submit all applications and regulatory documents to the Institutional Review Board (IRB) and ancillary committees. Coordinate and attend study monitoring visits including: pre-study site selection visits (PSSV), site initiation visits (SIV), interim monitoring visits (IMV), and close out visits (COV) for trials. Maintain current and accurate documentation in clinical trial management system (OnCore), source documents, and Investigator Site File (ISF). Recruit patients and screen for eligibility, coordinate and schedule treatments and follow-up visits, abstract patient data from medical records, and ensure compliance with research protocols. Serve as a liaison between Principal Investigator (PI), study sponsor, contract research organization (CRO) and patients. Develop novel recruitment strategies, attend community outreach events and health symposiums to boost trial and institutional exposure. Provide recommendations for procedures to improve efficiency and workflow within research groups, create standard operating procedures (SOPs) for the clinic.

• Assistant Research Specialist - Department of Neurology

  • Aug 2012 - Dec 2019

  Irvine, CA Manage daily operations of dynamic neuroscience research laboratory focused on brain network organization and function. The Conte Center at UCI: Coordinate and run human MRI portion of a cross-species investigation into connections between early life experience and vulnerability to mental illness. Recruit subjects, collect and analyze magnetic resonance imaging (MRI) data, present results and help prepare manuscripts to ensure continued funding. Sports Neurology Program: Worked… Show more Manage daily operations of dynamic neuroscience research laboratory focused on brain network organization and function. The Conte Center at UCI: Coordinate and run human MRI portion of a cross-species investigation into connections between early life experience and vulnerability to mental illness. Recruit subjects, collect and analyze magnetic resonance imaging (MRI) data, present results and help prepare manuscripts to ensure continued funding. Sports Neurology Program: Worked with UCI Athletic Department to study changes in brain network organization and function in all UCI athletes over the course of play. Administered concussion and behavioral testing to all athletes, scheduled and ran MRI and electroencephalography (EEG) procedures, collected accelerometer data from water polo and soccer players during games and practices. Coordinated and analyzed survey data in the first-ever study on the risks of head injury and concussion in the sport of water polo, prepared and submitted a manuscript with our findings. Stroke studies: performed chart reviews and recruited patients at bedside from UCI Medical Center, administered cognitive and motor tests, assisted in MRI and EEG procedures, assessed natural recovery from stroke by performing monthly in-home cognitive and motor testing for one year. Regulatory: complete and submit new protocol applications, modifications, and continuing protocol applications, prepare for and engage in auditing and study monitoring procedures. Maintain regulatory documentation for all studies. Data analysis and general laboratory responsibilities: run QA on MRI data, preprocess and analyze MRI and DTI data, train individuals on safety and operation of Philips 3T MRI scanner, maintain databases and spreadsheets, schedule meetings and interviews, train new staff, assist in grant applications and progress reports.