HELY PATEL
Kitchener,ON
Summary
I am a PHARMD (Doctor of Pharmacy) graduate who also has an ACRAC (Advanced Clinical Research Associate Certification) and a CCRP (Certification of Clinical Research Professional), currently working as a Clinical Research Coordinator at Winterberry Family Medicine, Hamilton, with over 14 months of clinical trial experience. Good working knowledge of international, Canadian and US clinical research regulations. Trained in ICH GCP (E6(R2), E2, E8), F&DA div. 5, FDA 21, CRF 312, 56, 50, 54 & Form 1572, IND & NDA.
Overview
3
3
years of professional experience
1
1
Certification
Work History
CLINICAL RESEARCH COORDINATOR
Winterberry Family Medicine
05.2023 - Current
- Collaborated with PI, CRCs, Clinical Manager and Trial Management Group to respond to any audit findings and implement approved recommendations
- Managed multiple studies in different therapeutic areas
- Coordinated with PI, CRCs and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsor policies and procedures
- Planned and coordinated the initiation of research study protocol, and the establishment of operating policies and procedures
- Coordinated all regulatory trial information with Trial Management Group (TMG)
- Monitored the progress of research activities; developed and maintains records of research activities, and prepares reports, as required by investigators, administrators, sponsors, and regulatory bodies
- Networked with community agencies and groups.
REMOTE CLINICAL TRIAL ASSISTANT (Intern)
International Clinical Research Academy
02.2023 - 05.2023
- Time in the International Clinical Research Academy, Montreal in phases 2, 3 and 4 clinical trials on Metabolic Syndrome, LDL-Cholesterol, and Diabetes.
- Worked to prepare more detailed SOPS for a Tool Kit for the new Site Management Organization Access Clinical Research Inc associated with the Academy, a start-up for company blocked by the lockdowns.
- Filled-in feasibility questionnaires for the CTSI.
CLINICAL TRIAL ASSISTANT
Cliantha Clinical Research Organization
09.2020 - 06.2021
- Assisted CRAs and RSU team with accurately updating and maintaining clinical documents and systems.
- Accompanied CRAs on site visits to assist with clinical monitoring duties and assisted with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Education
Healthcare Administration & Service Management -
Conestoga College
ON, Canada12.2022
Doctor of Pharmacy (PharmD) -
KSV University
Gandhinagar, IND06.2021
Skills
- Regulatory Reporting
- Site Visits and Site Monitoring
- Trial Oversight
- Clinical Documentation
- Protocol Adherence
- Integrated Medical Reporting
- Site & Project Management
- Investigator Meetings
- EDC: Veeva Learning, Medidata Rave, CTMS
- MS Office: Word, Excel, Outlook, PowerPoint
- Access
- Adobe Acrobat
Areas of Expertise
- Neurology
- Vaccination
- Obesity
- Diabetes
Certification
Advanced Clinical Research Associate Certification (ACRAC) from Certified Clinical Research Professionals Society
Certified Clinical Research Professional (CCRP) from International Clinical Research Academy
Timeline
CLINICAL RESEARCH COORDINATOR
Winterberry Family Medicine
05.2023 - Current
REMOTE CLINICAL TRIAL ASSISTANT (Intern)
International Clinical Research Academy
02.2023 - 05.2023
CLINICAL TRIAL ASSISTANT
Cliantha Clinical Research Organization
09.2020 - 06.2021
Healthcare Administration & Service Management -
Conestoga College
Doctor of Pharmacy (PharmD) -
KSV University
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