Clara Sam Email & Phone Number

Monterey Park, Ca, Us

Aliso Viejo, California, United States

- Contracts processing and execution- Facilitate development and QC of internal documents- Development of processes and controlled documents- Manage HCP/HCO clinical engagement activities per Avanir policies and procedures- Manage and/or support clinical audit activities as assigned- Perform reporting requirements including review and audits of clinical aggregate spend data to ensure accuracy and completeness as required per the Sunshine Act reporting process- Collaborate in the development, review, implementation and updating of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team (e.g. quality, efficiency, consistency)- Lead management of clinical systems updates, enhancements and master data stewardship as required- Manage coordination of activities across clinical teams for the completion and continued execution of process improvement and compliance related initiatives as assigned- Responsible for tracking and reporting of Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations related activities as assigned- Collaborate/Interact with internal and external stakeholders as related to conduct of required job responsibilities

Clinical Research Coordinator (May 2014-present)- Coordinate multiple clinical trials testing drug therapies (i.e. gene therapy) for neuromuscular and autoimmune disorders (i.e. SMA, DMD, LEMS)-Primary coordinator for 3 gene therapy trials and supervising coordinator for 4 gene therapy trials- Responsible for obtaining and submitting all regulatory documents to ensure committee approvals are obtained for clinical trials to begin and to update institutional applications (i.e. protocol amendment, change in safety)- Liaison for subjects, caregivers, the PI, Sub-Investigators, pharmacists, other coordinators, monitors, Sponsors, and various UCLA committees- Perform protocol procedures such as 12-lead ECG, holter placement, and specimen processing- Process muscle and nerve tissue during muscle biopsies and prepare them for pathological analysis- Lead coordinator for FDA audit on two clinical trials which concluded with no findings/observationsSupervisor (August 2017-present)- Supervise 6-8 clinical research coordinators - Manage employee workload and provide evaluations, support, and training- Development and implementation of practical continuous improvement processes- Maintain communication with various committees and departments (i.e. Institutional Review Board, Institutional Biosafety Committee, Investigational Pharmacy)- Reconcile research transaction reports for over 30 studies - Train staff to perform research coordinator tasks and to properly utilize the lab space/equipment- Ensure staff certifications are obtained and remain valid - Assist with creating and updating Standard Operating Procedures- Troubleshoot and facilitate the resolution of issues that occur in both the Neuromuscular Research Office and Dr. Perry Shieh’s Lab- Communicate with UCLA Department of Neurology’s Central Administration Staff to facilitate with personnel matters such as hiring and raises/promotions and to obtain enough office and lab space to conduct clinical trials

Westwood

-Analyze various data to generate reports for presentation, projects, and meetings-Maintain an ancillary program, a database containing patient data, that is utilized by over 200 employees and resolve any issues that arise-Train and provide support to over 100 staff (including the director and 7 managers) pertaining to many various topics (e.g. computer programs, requesting funds, documentation of data, and technical issues) -Manage 5 gift fund accounts by reconciling over 500 invoices totaling over $1,000,000 and requesting additional funds-Coordinate/schedule meetings (ranging from 2-100 attendees) for the director involving C-Level Executives, Medical Doctors, Directors, Managers, Consultants, and/or Staff

-Responsible for administrative tasks- reorganize and update paper and electronic files; maintain attendance calendar; schedule oncology appointments; answer phone calls (5 different lines); e-mail and scan documents; sort and send faxes-Analyze appeal data to create various charts, tables, and diagrams for monthly meetings-Process insurance authorizations, time-off requests, and other forms

-Performed general administrative duties- organized and maintained paper and electronic files; answer phone calls (3 different lines); fax, e-mail , and copy documents; make travel arrangements-Communicated effectively with over 25 clients regarding their tax matters on a daily basis-Responsible for issuing payroll checks ranging from $4,000-$75,000 for over 50 companies and calculated payroll taxes-Organized a variety of tax forms for over 700 individuals and companies-Prepared bookkeeping- cash disbursement journals and bank reconciliation-Compiled corporate governance information for new clients

- Maintain personnel files to ensure all required Joint Commission Accreditation documentations are completed accurately.- Help update the Human Resources Tracking System for new hires, rehires, and transfers.- Send out compliance reports to Medical Center departments.

-Revise the educational materials and policies in the training manual for the Ambassador program.-Communicated effectively with over 80 companies and 15 UCLA/Medical Center Departments regarding information for the training manual.-Helped with organizing and reorganizing special projects-Auxiliary Awards Luncheon and Revising Volunteer Applications.

-Recruit and interact with participants and their parents on a daily basis.-Schedule and maintain appointments on Google Calendar.-Assist a graduate student with his study called “Infant-Directed Faces versus Happiness” (IDvH) by helping with conducting the study and analyzing data.-Created and wrote a poster presentation for IDvH, which was presented at 2 conferences.

B.A., Psychology

Activities and Societies: -Mortar Board National College Senior Honor Society -College Honors Program -Golden Key National Honour Society.

Education record