DESHNA SHAH
San Jose,California
Summary
Experienced Clinical Research Associate with a demonstrated history of working in the hospital & health care industry. Skilled in Electronic Data Capture (EDC), Institutional Review Board (IRB), Spectroscopy, and Oncology. Highly motivated and passionate about Clinical Trials Research and Management. And have a good understanding of all phases of Clinical Trial and Design and foundations of Protocol Development, Data Management, and Clinical Site Activities. Worked with oncology, dermatology, orthopedic, hematology and respiratory therapeutics areas.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr Clinical Trial Coordinator
CDE medical associates and LCGK Research center
05.2022 - Current
- Assists in the planning, implementation, and coordination of clinical research studies
- Responsible for ensuring compliance with all relevant regulations, guidelines, and institutional policies
- They help prepare and submit regulatory documents such as study protocols, informed consent forms, and applications to ethics committees or regulatory authority
- Provide assistance to Research staff by organizing files, projects, information and data
- Collect, process, and assist in the compilation and verification of Research data, samples, and/or specimens (following strict protocol and detailed instructions)
- Enter data from Source documents into databases and other documents
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
- Become familiar with Research SOPs and study protocols
- Collect, process, and ship blood/urine/stool specimens at patient visits
- Complete and maintain case report forms per FDA guidelines, and review them against the “patient s medical record for completeness and accuracy
- Ensure the filing and maintenance of all regulatory documents
- Maintain temperature logs, assist coordination with preparation of source documents
- Assist with subject recruitment by performing chart reviews, cold calling, etc
- Schedule patient visits, Process Lab specimens, Assist with vital signs, Phlebotomy
Patient Treatment Coordinator
Crystal Family Dental Care
05.2021 - 04.2022
- Communicated with insurance companies to verify coverage and obtain authorizations for medical treatments and procedures.
- Maintained confidentiality of patient data and condition to safeguard health information.
- Acted as main point of contact for patients, doctors, and hospital staff by closely reviewing medical charts and maintaining high levels of communication.
- Assisted patients with completing necessary paperwork and forms to provide healthcare facilities with essential information to bill for services.
Clinical Research Coordinator
Rathi Hospital and Research Center
09.2016 - 04.2021
- Coordinated and managed clinical research studies in compliance with regulatory guidelines, study protocols, and Good Clinical Practice (GCP) standards
- Assisted in the development and implementation of study protocols, including participant recruitment strategies, data collection methods, and study timelines
- Screened and enrolled eligible participants for clinical trials, explaining study procedures and obtaining informed consent
- Conducted participant assessments, administered questionnaires, performed physical examinations, and collected biological samples as per study protocols
- Ensured regulatory compliance by preparing and submitting required documents, such as study protocols, informed consent forms, and regulatory submissions to ethics committees or regulatory authorities
- Monitored study progress and protocol adherence, conducting site visits and data monitoring activities
- Reported adverse events and participant safety concerns promptly, following regulatory guidelines and study protocols
- Facilitated effective communication and collaboration between the research team, participants, sponsors, and other stakeholders
- Provided training and support to study staff, ensuring consistent implementation of study procedures and adherence to protocol
General Dental Surgeon
Parvati Jadav Hospital And Research Center
09.2014 - 12.2016
- Prescribed medication to improve recovery and control pain after procedures.
- Used rotary and dental appliances and surgical implements to clean, fill, extract and replace teeth.
- Removed impacted and non-restorable teeth, both during surgeries and day-to-day procedures.
- Consulted with patients and analyzed patient data to determine patient needs and treatment goals.
Education
Master of Science - Information Technology
University of Cumberlands
Williamsburg, KY08.2021
Bachelor of Dental surgery (B.D.S) - Health Care
AMC Dental College & Hospital
Ahmedabad, India08.2014
Skills
- Medidata Rave
- Patient Record Database Management
- Patient Information
- Patient Recruitment
- Good Clinical Practice
- Research Protocol Development
- Audit Monitoring
- Meeting Minutes
- Clinical Trials and Research
- Data Collections
- Informed Consent
- Lab Tests
- Dispensing Oversight
- Following Sops
- Standard Operation Procedures
- Invoice Reconciliation
- Case Report Management
- Risk Mitigation Strategies
- Trial Management
- Collections Processing
- Study Protocols
- Trip Reports
- Electronic Medical Record
- Regulatory Requirements
- Trial Close
Certification
1. NIDA Good Clinical Practice Certification.
2 Mayo Clinic Laboratories -Handling/Offering for transportation of Dangerous Goods Certificate
3 EDC- Veeva vault Data Capture certificate
4 GZGS &GPGN Study Central lab certificate
5 Occupational Health and safety certificate
6 Trained in Cardiopulmonary Resuscitation
Timeline
Sr Clinical Trial Coordinator
CDE medical associates and LCGK Research center
05.2022 - Current
Patient Treatment Coordinator
Crystal Family Dental Care
05.2021 - 04.2022
Clinical Research Coordinator
Rathi Hospital and Research Center
09.2016 - 04.2021
General Dental Surgeon
Parvati Jadav Hospital And Research Center
09.2014 - 12.2016
Master of Science - Information Technology
University of Cumberlands
Bachelor of Dental surgery (B.D.S) - Health Care
AMC Dental College & Hospital
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