Summary
Overview
Work History
Education
Skills
Therapeutic Experience
Timeline
Generic

Usat Yind

Richmond,TX

Summary

Hardworking and detail-oriented Clinical Research Associate with 6 years of Clinical Research experience in Clinical trials phases I, II, III, and IV in varying therapeutic areas. Highly skilled in Electronic Data Capture (EDC), Good Clinical Practice (GCP), and Clinical Trial Management System (CTMS). Excellent knowledge of Good Clinical Practice, and FDA regulations.

Demonstrated leadership and high-performance CRA II competencies plus experience performing PSV, SIV, RMV, and COV site visits.

Overview

9
9
years of professional experience

Work History

Senior Clinical Research Associate

Syneos
08.2019 - Current
  • Ensure trip reports are completed to quality standards within company-specified timelines.
  • Act as primary liaison for assigned study sites while on-site to convey project information, and answer questions.
  • Address study issues in accordance with monitoring plans.
  • Maintain required documentation in the investigator site file and provide required documentation for Trial Master File.
  • Manage investigational product supplies to trial sites. Keep track of drug lots/batches and expiration dates, and assist in investigational product forecasting in accordance with study agreements.
  • Implement electronic data capturing systems to adhere to clinical research guidelines.
  • Perform on-site drug accountability and reconciliation, and verifies drug storage meets protocol and SOP requirements.
  • Conduct initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Verify patient eligibility, communicate and document protocol violations, non-compliance, and poor performance and ensure corrective actions are taken
  • Perform ongoing reviews of Investigator’s Trial File to assure the quality of the documentation files, completion and compliance with company SOPs, GCP and ICH Guidelines while on site.
  • Complete follow-up letters for all visit types according to SOPs and completed reports to quality standards within company-specified timelines.
  • Liaise with other CRAs to ensure the harmony of standards and procedures.

Clinical Research Associate II

Syneos
05.2017 - 08.2019
  • Responsible for conducting site visits (initiation, monitoring, and termination) to assigned investigational sites to ensure studies were being conducted according to the protocol, project plan, ICH GCPs, and FDA regulations.
  • Ensured sites were adhering to the FDA and ICH-GCP regulations and that new study updates and guidelines were implemented as required.
  • Completed visit reports and sent out follow-up letters to sites within the stipulated timeline.
  • Ensured adherence to local regulations and company SOPs.
  • Ensured the completion and collection of regulatory documents.
  • Provided clear and concise instructions to the site staff on their roles and responsibilities in conducting clinical trials.
  • Evaluated and reported site performance and protocol compliance.
  • Performed data verification of source documents and ensured CRFs were consistent with source and accurately completed.
  • Collected and shipped paper CRFs to the sponsor, or verified electronic CRFs.
  • Verified that written informed consent was obtained before each subject’s participation in the trial.
  • Performed investigational product accountability and tracked IP supply to ensure that sites had adequate drugs for the study conduct.
  • Ensured completion and collection of SAEs and also ensured that they were being reported to the sponsor and IRB in a timely fashion.
  • Ensured PIs reviewed IND Safety Alerts and that they were reported to the IRB as required.
  • Assisted with data validation and resolution of queries.
  • Completed visit reports and sent both pre-visit and post-visit communication to sites in a timely manner.
  • Completed all administrative tasks (Such as calendar updates, expense reports, timesheets, etc.) in a timely manner.
  • Ensured compliance with company SOPs.

Clinical Research Associate I

Syneos
02.2015 - 05.2017
  • Attended internal meetings and prepared team agenda and meeting minutes.
  • Worked with Feasibility teams to provide support in the distribution and collection of feasibility questionnaires to investigators being considered for study participation.
  • Responsible for monitoring all stages of the conduct of clinical trials in assigned study site which included performing study Site Selection visits, Site Initiation visits, Routine Monitoring visits, and Close-out Visits according to company SOPs.
  • Ensured trip reports were completed to quality standards within company-specified timelines.
  • Maintained required documentation in the investigator site file and provided required documentation for the Trial Master File.
  • Ensured assigned trial sites complied with study protocol, GCP, and applicable regulatory requirements for performing study activities regarding the implementation and monitoring of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs.
  • Managed investigational product supplies to trial sites.
  • Kept track of drug lots/batches and expiration dates, and assisted in investigational product forecasting in accordance with study agreements.

Study Coordinator

HCA Houston Healthcare
11.2013 - 02.2015
  • Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
  • Followed informed consent processes and maintained records. Devoted special emphasis to punctuality and worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Educated Patients about all facets of clinical study participation.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols.

Education

Bachelor of Science - Nursing

Grand Canyon University
Phoenix, AZ

Skills

  • Proficient in the use of electronic data capture systems (EDC : Medidata Rave, Inform, OCRDC)
  • Knowledge of Clinical Trial Management Systems (CTMS : IMPACT) and IVRS systems
  • Electronic trial master file (eTMF)
  • Sound knowledge of Good Clinical Practices (ICH-GCP) and FDA regulations
  • Conversant with the design and review of Case Report Form (CRF)
  • Research and Inventory Management
  • Completing regulatory documents
  • Computer Skills: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Access)

Therapeutic Experience

· Oncology: Breast Cancer, Ovarian Cancer, Prostate Cancer, Lung Cancer, CLL, AML

· Infectious Disease – TB, Hepatitis B, Bacteria Meningitis, COVID 19, Influenza

. Gastrointestinal: Crohn's disease, Ulcerative Colitis

· Cardiovascular: Congestive Cardiac Failure, Essential Hypertension

. CNS: Alzheimer's Disease, Parkinson’s Disease, Schizophrenia, Epilepsy

· Medical Device: IVD, Heart Valve, Pace Maker, Cardiac Stent, Sphygmomanometer, Intrauterine contraceptive device (IUCD)




Timeline

Senior Clinical Research Associate

Syneos
08.2019 - Current

Clinical Research Associate II

Syneos
05.2017 - 08.2019

Clinical Research Associate I

Syneos
02.2015 - 05.2017

Study Coordinator

HCA Houston Healthcare
11.2013 - 02.2015

Bachelor of Science - Nursing

Grand Canyon University

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Usat Yind