Usha Toky
Frisco,TX
Summary
Highly committed and detail-oriented Clinical Research Associate well-versed in coordinating clinical trial operations, study monitoring plans, managing sites and drafting detailed clinical reports. Diligent in performing studies aligned with protocols and regulatory requirements following ICH-GCP guidelines. Carry in-depth knowledge and experience in vaccine and infectious diseases, cardiology, gynecology, GI, oncology and central nervous system research studies. Extremely passionate, organized and committed to subject safety, protocol compliance and data integrity
Overview
24
24
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
ICON Clinical Research
2022.03 - Current
- Monitor clinical sites to ensure that study protocol and in accordance with ICON SOPs/WPs, applicable regulations and principles of ICH –GCP
- Closely work with Research Scientists in designing and implementing clinical trials
- Support Clinical team in their research process on subjects Perform Site selection study start-up, PSV, SIV, COV and interim monitoring visits Perform Source Data Review/Verification and submit reports for Monitoring Visits
- Check EDC data entry for integrity and compliance
- Conduct investigator's Site File review, assess qualifications of study personnel as per protocol requirements
- Identify site issues, protocol deviations, Serious Quality Events and initiates Corrective Actions and Preventive Actions & report to the study team and sponsors
- Ensure and assist sites inspection readiness for sponsor or FDA audits Verify drug accountability for completeness, accuracy and storage requirements Ensure all AEs, SAEs, SUSARs are reported to IRB/ IEC and sponsors in timely manner
- Ensure coordination with investigative sites, study teams, sponsors & cross functional teams.
Clinical Research Coordinator
AIM Trials
2020.10 - 2022.02
- Conducted Screening and consenting subjects per study protocols and SOP
- Conducted study visits and relevant procedures for subjects per study protocols and design
- Dispensing study medication and clinical study devices per protocol
- Updated IWRS for screening, randomization, screen failure, IP receipt & management Document and report of AEs and SAEs per CRO policy, study protocol, Sponsor, IRB, and ICH-GCP guidelines
- Maintained subject source documentation accurately as per ICH-GCP and ALCOA
- Participated in investigators meetings, PSSV, SIV, COV & interim monitoring visits
- Assisted PI in conducting research studies according to study protocol, sponsors' regulations and guidelines and FDA regulations
- Completed CRF in EDC accurately and Timely query resolution for all assigned studies.
Medical Director/Clinical Trial Manager
Park Pharmaceuticals
2003.01 - 2009.01
- Provided Scientific Expertise & oversight to drug development and clinical trial project teams
- Generated protocol and program planning documents Worked closely with study team in regards to conduct of clinical studies and preparation of data reconciliation, protocol deviation management and safety reporting
- Interacted with internal teams & external stakeholders in support of clinical study objectives
- Performed scientific literature and relevant research to support regulatory submissions
- Evaluated study data analysis and reviewed reports per inclusion & exclusion criteria
- Actively participated in investigator meetings and corresponded with sites and ICMR
- Actively participated in safety management and ensured that all activities within the organization are per GCP, GMP and ICMR guidelines.
Resident Medical Doctor
Prime Diagnostic Center and Heart Institute
2002.02 - 2002.09
- Provided in-patient and out-patient intermediate services in all aspects of cardiology
- Performed assessments of various cardiovascular diseases diagnosis and provide treatment for diseases like hypertension, tachycardia, myocardial infarction, congestive heart failure, and various other cardiovascular diseases
- Performed medical history, physical examination, diagnosis, and prescribed treatment accordingly
- Ordered and performed early detection screening tests for various cardiovascular diseases and analyzed reports, medical reports and provided treatment plans accordingly
- Conducted echocardiography, TMT, Stress echocardiography and ECG on patients
- Interfaced with patients on regular basis regarding follow-up treatment plans and medical tests in cardiac care units
- Participated in annual conference of Indian Association of Cardiology
Resident MD Intern
Government Hospital, Sector 6
2000.10 - 2001.10
- Responsible for providing all phases of patient care including in-patient and out-patient treatment and care
- Participated in health care services in emergency, pediatrics, internal medicine, cardiology, obstetrics and gynecology.
Education
Master's in Public Health -
Lamar University
Beaumont, Texas10.2022
Bachelors in Alternative Medicine and Surgery -
MD University
India10.2001
Diploma in Pharmacy -
Government Polytechnic College For Women
India08.1994
Skills
- Site Management and Monitoring
- Pharmacovigilance
- Electronic Data Capture
- ICH/GCP Guidelines
- Drug Accountability
- Informed Consent Process
- Patient Safety, Protocol Compliance and Data Integrity
- Project monitoring and Biostatistics knowledge
- Adverse event reporting
- Clinical trial management
Certification
- Cell and Gene Therapy Certified
- ICH-GCP Certified
Hands On Experience
Siebel CTMS, IcoTrial, PTMF, Firecrest, IMedidata RAVE, MyTrials, Veeva Vault, TMF, Oracle InForm, ClinOne, DSG, Florence, Complion, CRIO, One Drive, Shared Investigator Platform, RealTime, Pfizer Impala, IView2, TrialManager
Clinical Research Summary
Extensive experience working in all Clinical trials phases (I, II, III and IV)Therapeutic Areas: Vaccine and Infectious diseases, Internal Medicine, CNS, Hormonal Therapy, Oncology, Respiratory, Pediatric internal medicine, Gastrointestinal System
Timeline
Clinical Research Associate
ICON Clinical Research
2022.03 - Current
Clinical Research Coordinator
AIM Trials
2020.10 - 2022.02
Medical Director/Clinical Trial Manager
Park Pharmaceuticals
2003.01 - 2009.01
Resident Medical Doctor
Prime Diagnostic Center and Heart Institute
2002.02 - 2002.09
Resident MD Intern
Government Hospital, Sector 6
2000.10 - 2001.10
Master's in Public Health -
Lamar University
Bachelors in Alternative Medicine and Surgery -
MD University
Diploma in Pharmacy -
Government Polytechnic College For Women
- Cell and Gene Therapy Certified
- ICH-GCP Certified
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