Charmi R. Gohil
Lake Worth
Summary
Healthcare professional with a strong background in clinical research, driving operational excellence and regulatory adherence. Proven ability to manage complex trials effectively, ensuring patient safety and compliance through strategic oversight and thorough training initiatives.
Overview
1
1
Certification
14
14
years of professional experience
Work History
Clinical Research Coordinator
Segal Drug Trials, Inc
Delray Beach
04.2022 - Current
- Management of research operations including creating and updating Standard of Procedures periodically.
- Generating training documents pertaining to study specific protocols for staff training and education.
- Create, update, review and maintain Office regulatory policies and plans like Exposure control and training for the continued employee and staff education for safety and awareness
- Facilitated communication with NIH and FDA regarding study-specific protocol requirements and ethics committee matters.
- Managed regulatory responsibilities for study start-up through close-out for all studies.
- Provide operational, regulatory and administrative support and regulation to the PI and study staff for outside assigned clinical research sites affiliated to Segal Drug Trials,INC.
- Coordinated study activities, including start-up, monitoring visits, IRB submissions, regulatory binder maintenance, complex assessments, EDC data entry, investigational product shipment handling, and product dispensing, ensuring compliance throughout all assigned clinical trial protocols.
- Implement and coordinate the protocol specific assessments, oversee eligibility criteria (inclusion/exclusion), screening and recruitment activities.
- Assures adherence to study related to clinical research good practice, ethics in alignment with the SOP of the company.
- Provides leadership in protocol implementation, answering queries on EDC, identifying ethical conflicts if any, handling AE and SAE and reporting them according to the IRB regulations and sponsor requirements.
- Monitoring, documenting, reporting, and follow up on the unanticipated occurrences and protocol deviations.
- Point of contact for the monitoring activities, study start up, follow up visits, IP visits, and close out visits.
- Keep the sponsor and the PI informed of the protocol progress and statistics.
- Ensure patient safety in relation with the investigational product.
- Managed study activities to ensure compliance with protocols and timelines across multiple therapeutic indications, including glaucoma, obesity (GLP-1), dermatitis, gene therapy for age-related macular degeneration, presbyopia, demodex blepharitis, dry eyes, conjunctivitis, and pterygium.
- Managed study activities to ensure compliance with protocols and timelines across multiple therapeutic indications, including glaucoma, obesity (GLP-1), dermatitis, gene therapy for age-related macular degeneration, presbyopia, demodex blepharitis, dry eyes, conjunctivitis, and pterygium.
Clinical Research Technician I
Aventusoft LLC
Boca Raton
01.2022 - 04.2022
- Conduct HEMOTAG data collection in patients' private homes during the visit.
- Performs study procedures, routine tests, data collection and daily operations of protocols.
- Oversaw medical device HEMOTAG during clinical studies, ensuring proper usage and compliance.
- Performs and records ECG/HEMOTAG positioning and data transmission.
- Participant initial screening and consent form administration/maintenance.
- Maintained and organized study-related documents for Regulatory, Quality, Clinical, and Engineering teams.
- Collaborated with Aventusoft's engineering staff, principal investigator, and clinical site staff to support clinical studies.
- Work with the hospital team and Aventusoft clinical team, to coordinate patient visits and document data collection.
- Work together with the Regulatory Specialist to ensure compliance.
Senior Pharmacist
Samvedan Hospital - Astu Pharmacy
Rajkot
02.2016 - 02.2017
- Consulted with physicians and patients on dosage, drug information, medical equipment, and side effects of prescriptions while maintaining accurate patient information for future use.
- Designed and maintained the drug racks by their mechanism of action and generic names for ease of access. This made prescription the filling process efficient and faster by approximately 30%.
- Achieved 12-15% revenue increase in FY2013 by selecting appropriate vendors.
- Negotiated with various drug vendors for drug delivery and improved the overall maintenance of the purchase register.
- Dr. Nisheeth Patel
Pharmacist
Wockhardt Hospitals
Rajkot
10.2012 - 03.2014
- Dispensed medications accurately and efficiently to patients and healthcare staff.
- Reviewed prescriptions for potential drug interactions and contraindications.
- Provided medication counseling to patients regarding proper use and side effects.
- Managed inventory to fulfill 2200 weekly prescriptions for in-patient and out-patient services.
- Managed vendor selection by evaluating delivery times, quality, and cost-effectiveness to ensure efficient drug supply.
Education
Masters - Healthcare Administration
FLORIDA ATLANTIC UNIVERSITY
FL12-2021
Bachelors - Pharmacy
SAURASHTRA UNIVERSITY, R.K. COLLEGE OF PHARMACY
Rajkot, Gujarat06-2011
Skills
- Clinical trial management
- Clinical Compliance
- Trial oversight
- Operational oversight
- Data Management
- Risk assessment
- Management
- Problem solving
- Critical Thinking
- Leadership skills
Certification
- VIARES Clinical Research Project Management Certification
- Good Clinical Practice (GCP) Certification Through CITI Program
- IATA (Dangerous Goods) Certification
Timeline
Clinical Research Coordinator
Segal Drug Trials, Inc
04.2022 - Current
Clinical Research Technician I
Aventusoft LLC
01.2022 - 04.2022
Senior Pharmacist
Samvedan Hospital - Astu Pharmacy
02.2016 - 02.2017
Pharmacist
Wockhardt Hospitals
10.2012 - 03.2014
Masters - Healthcare Administration
FLORIDA ATLANTIC UNIVERSITY
Bachelors - Pharmacy
SAURASHTRA UNIVERSITY, R.K. COLLEGE OF PHARMACY