Experience

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  Popeyes louisiana kitchen

  Oct 1998 - Oct 1999

  Shift supervisor

  Played a key role in the operation of restaurant, with accountability for directing the team and ensuring compliance with company standards in all areas of daily operations. • Training and motivating team members• Designed efficient work processes. • Customer relations • Financial accountability during shifts• Ensured that the highest quality products and services were delivered.• Inventory management

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  Kentucky fried chicken kfc

  Oct 1999 - May 2000

  Shift supervisor

  Played a key role in the operation of restaurant, with accountability for directing the team and ensuring compliance with company standards in all areas of daily operations. • Training and motivating team members• Designed efficient work processes. • Customer relations • Financial accountability during shifts• Ensured that the highest quality products and services were delivered.• Inventory management

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  Dr. bruce larson, endocrinology

  Jan 2001 - Dec 2001

  Medical assistant

  Provided routine clinical and administrative support to the provider in an outpatient clinic setting (Front office/Back office) • Performed rooming and/or intake process, collecting and data, including vital signs, height, weight, and data related to patient's reason for visit, medication history and allergy history• Assisted the provider as directed, during treatments, examinations, and procedures ( ie., thyroid biopsies)• Ensured patient safety by following infection control protocols• Assisted in patient education and provided resources to patients regarding endocrine conditions• Coordinated appointments/scheduled tests Show less

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  Kaiser permanente

  Dec 2002 - Jan 2004

  Ward clerk transcriber

  Responsible for supporting and coordinating the administrative activities of the nursing unit. Assigned to cover multiple units as a floating ward clerk, i.e., Telemetry, Med/Surg, NICU, CCU, ICU, Labor and Delivery, and Emergency room.• Transcribed written physician orders • Called or faxed prescriptions to pharmacy • Updated the unit’s white board.• Answered and appropriately routed internal and external telephone calls.• Answered call system; followed up with the nurse, patient and/or family as appropriate.• Made follow-up appointments for patients as necessary.• In conjunction with Discharge Coordinator, organized transfers to skilled nursing facilities • Prepared discharge packets and other documents for patients.• Scheduled tests and coordinated patient care activities in collaboration with the RN and other departments to assure timely and appropriate action.• Coordinated hospitalization transfer and transportation. Show less

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  Axis clinical trials

  Jul 2006 - Feb 2013

  Responsible for taking the lead mentoring role of clinical research coordinators and research assistants, quality improvement, operations, management, coordination, and project management planning. Oversaw direct reports of 20+ research employees. Supported a culture of continuous improvement, quality, and productivity. • Managed all clinical research staff including investigators, coordinators, lab, and research assistants to ensure optimal performance on each study. Provided timely feedback on employee performance, helping to develop team members’ skills where needed, and addressing performance problems. • Ensured all personnel obtained detailed knowledge of all components of study protocol through review of study and training, prior to the study effective date, to ensure protocol compliance. In addition to setting clear expectations, designing efficient workflows, creating tracking mechanisms, performing quality checks, mentoring/motivating team members to perform at peak level. • Ensured the research team developed and implemented an effective enrollment plan to ensure subject enrollment consistent with the sponsor’s protocol and enrollment period.• Provided direction and support to research team during subject screening to ensure qualified subjects were identified and enrolled in the study in a timely manner. • Performed QA/QC audits and source data verification reviews which in great deal included: writing SOPs, creating corrective actions plans, reporting IRB reportable findings, and ensuring staff compliance with research specific training. • Oversaw 4 FDA site audits and numerous routine IRB and Sponsor Audits• Assisted with organizing and conducting Staff Meetings at regular intervals and helped address issues discovered at meetings.• Ensured case report forms were complete and accurate and maintained by Coordinators/Data Managers per FDA and sponsor requirements. Show less Lead Clinical Coordinator for high enrolling fast-paced clinical research site for industry sponsored research projects in Phase I - IV in various specialties, such as: neurology, cardiology, urology, infectious disease, gastroenterology, gynecology, pulmonology, endocrinology, dermatology, and rheumatology. Oversaw large teams for high enrolling studies (i.e., 1000 + participants).• Coordinated the conduct of all the key research activities. Not limited to recruiting, consenting, medical history and medication review, subject enrollment, AE/SAE reporting, the gamut of IRB submissions, source document creation, data entry and query resolution, IP dispensing/ Drug Accountability, unblinded pharmacist role, subject compliance, and performing a wide range of clinical procedures (ie., phlebotomy, pap smear assisting, colposcopy assisting, urinary cath. insertion, colposcopy/urinary bladder injection assisting, tattoos for derm studies, slide prep, PFT, Injections, biospecimen collection/processing/shipping). Show less • Assisted the Primary CRC with study recruitment, patient enrollment, and tracking as needed on high enrolling study • Assisted with study visits by performing consenting, study related clinical procedures, drug accountability/dispensing, and counseling subjects • Ensures study-related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.• Assisted the CRC with updating and maintaining logs and filing in charts• Assisted CRC by preparing all source documents and lab kits prior to study visits • Proactively maintained study supply inventory and ordered supplies as required for multiple projects • Data entry within 24-48 hours of study visit completion and query resolution Show less • Performed data mining tasks in multiple EMR partner systems to identify potential patients based on trial inclusion/exclusion criteria and medical records match with on-site or remote EMR access.• Created Phone Pre-screening scripts, marketing materials for media (radio, print, webpage)• Process potential volunteers (chart review, in-person, phone). Captured and reported detailed medical history, medication list, and assessed patient eligibility based on protocol inclusion and exclusion criteria and scripts.• Assisted and Supported Community Outreach, including community events or onsite visits, as needed.• Assisted in identifying new potential community partner opportunities Show less

  • Site Director

    Apr 2009 - Feb 2013

  • Lead Clinical Research Coordinator

    Jan 2007 - Feb 2013

  • Research Assistant

    Oct 2006 - Jan 2007

  • Research Trial Recruiter/Marketing

    Jul 2006 - Oct 2006
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  Ucla health

  Feb 2013 - Apr 2017

  Medical assistant

  Participated in the total patient care in the ambulatory setting in a multi-specialty office (Family Medicine, Sleep Medicine, Rheumatology, and Pulmonary Medicine, and Urgent Care). Interfaced with patients, families, and physicians in the coordination of all patient care services for a diverse patient population. Nominated for Medical Assistant of the year by UCLA Physicians in practice. Highly valued for going above and beyond to serve in the best interest of patients and colleagues in the practice. Often sought as the go to person to solve problems and provide guidance. Often encouraged medical assistants to implement efficient workflow process, enhance customer service experience, and overcome challenges faced. Participated in departmental process improvement activities, i.e., planning, measuring/ monitoring, assessing, and improving.• Rooming of patients which involved adeptly observing for abnormal clinical symptoms, obtaining vital signs, and reviewing medications • Administered oral, IM, intradermal and subcutaneous medications• Set up and assisted physicians with clinical procedures (ie., bronchoscopy, pap smears, suture)• Performed accurate patient sample testing for waived tests• Performed phlebotomy and sample processing • Submitted referral for various clinical needs such as consults, DME supplies, home health, hospice care, specialty medications/prior authorizations, and procedural request. • Maintained stock of clinical supplies • Performed quality checks and calibration of equipment • Front office duties such as answering patient calls and addressing concerns and request, registration, and scheduling follow up Show less

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  Ucla semel institute/ veterans affairs

  Apr 2017 - Aug 2019

  Clinical research coordinator

  Responsible for overall operational management of clinical research activities for psychiatry studies in phase II-IV at UCLA Semel Institute and at the Veteran's Administration. Direct responsibility for implementing a diverse portfolio of research activities for studies which included multicenter clinical trials (both NIH and industry-sponsored) and local investigator-initiated clinical trials. Close collaboration with the Principal Investigator (PI) of each study, to facilitate timely study progress reporting to the PI and enabling appropriate PI oversight and study management for safe and accurate completion of protocol required procedures in accordance with standard operating procedures, governing regulations, and study documents. Mentored junior staff on subject protections for clinical research compliance. • Preparation, submission, and maintenance of regulatory applications/submissions to fulfill research requirements of a given trial during a life cycle (i.e., new study submission, study modification, safety reporting, reportable events, continuing review, and close -out reports) • Created Standardized Operating Procedures for CAPAs. Quality Improvement focus. QA/QC functions • Development of source document worksheets, source data collection, data entry• Subject management, including recruitment, subject interfacing, consenting, building rapport, review medical/surgical and medication history, enrollment, drug dispensing/ drug accountability, clinical procedures, patient interventions under the supervision of the PI, perform structured interviews, tracking of results, safety reporting, and scheduling. • Lead weekly clinical trial meetings with an emphasis on goal progress for all research projects. Active participant during discussions involving recruitment strategies, motivation of referring clinicians, protocol design improvements, protocol and regulatory compliance, problem resolution, and efficiency suggestions. Show less

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  Jmmcri joint and muscle medical care institute

  Aug 2019 - Nov 2023

  Quality assurance coordinator/ regulatory coordinator

  Serve as an expert resource on quality improvement and provide advice on optimal strategies for performance improvement and compliance in accordance with GCP and FDA regulations. Support site for root-cause-analysis for corrective and preventative actions. Write SOPs. Create source documents with an emphasis on ensuring protocol adherence, subject safety, efficiency, and protection of data integrity. Preparation, submission, and maintenance of regulatory applications/submissions to fulfill research requirements of a given trial during a life cycle, i.e., new study submission, study modification, safety reporting, reportable events, continuing review, and close -out reports.• Oversaw FDA audit at site between 9/14/2020 - 9/18/2020 and performed QC/QA functions, creating CAPA prior to audit which led to a No action indicated (NAI) conclusion, i.e., NO FDA 483 was issued. • Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities• Identify discrepant data capture and verify appropriate corrections are made for any incorrect, missing, or incomplete data through confident, knowledge-based conversations with the leadership team, study investigators, and other appropriate study staff • Verified subject safety and site adherence to FDA regulations, ALCOA-C, ICH/GCP guidelines and protocol-specific requirements• QC Regulatory Binders ensuring Audit Ready State, Verification of research training/qualification compliance. • Quality Assurance/Source Data Verification – ensuring the subject charts are up-to-date and audit ready• Identify and assists in developing training programs for study staff and supporting departments • Co-lead inspection preparation meetings with team with a focus on inspection preparation at the study level for a key program Show less

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  Penn state health

  Mar 2024 - now

  Regulatory associate ii

  Responsible to assist clinical investigators with the implementation of all Cancer Institute clinical research protocols, to include administrative and regulatory aspects of study start-up, maintenance, and closure. Responsible for maintaining compliance with both internal (e.g., ORA, IRB) and external (e.g., FDA, NCI) requirements. Responsible in driving processes to ensure efficient and compliant study activation and maintenance, with attention to metrics driven goals for productivity. Ensure all files are maintained in an audit-ready fashion. Show less