Vrunda Patel Email & Phone Number

Toronto, Ontario, Canada

India

• Performed various assigned tasks to support team members with project execution (examples : running system reports, preparing and distributing status reports, creating and maintaining study documents, etc.).• Interacted with sites/clinical research associate and followed-up for action items, missing data, open query management, SDV backlog, visit schedule, protocol deviations, etc.• Prepared i-site pack for respective assigned sites for CRAs. • Ensured the maintenance of internal systems, databases, tracking tools and project plans.

• Reviewed and raised the correction requests based on the project specific annotations for the site visit report submitted by the Clinical Research Associate post site visits.• Interacted with the Clinical research associate and follow-up for the missing data at the site as provided in the site visit report.• Conducted the SRS-CL/CML monthly call to discuss the progress, risks and common trends of the project found during the reviewing process.• Used various software tools such as CTMS, SRS dashboard and SVRMT for maintaining the accuracy in the report reviewing procedure.

Vadodara Taluka, Gujarat, India

Developed a database for upcoming patient-oriented clinical trials• Trained in bio specimen trials involving tissue/tumor block preparation and storage from cancer patients via surgery or biopsy.

• Worked on: Multiple Phase II, III and observational multicentric open labelled/blinded/placebo controlled clinical trial in Oncology (mainly breast and ovarian cancer) • Ensured the conduct of the trials as per the ICH GCP & Protocol Specified Guidelines. • Performed Ethics Committee and Regulatory submissions. • Site set-up for pre-study and site initiation visits. Maintained source documents and transcribed data from source note to paper CRF and eCRF. • Facilitated informed consent process, screening and enrolment during the study period. • Managed clinical trial supply accountability, distribution and logistics, central lab logistics and sample flow. • Coordinated with CRAs for monitoring and auditors for audit visits. • Coordinated safety aspects viz. AE/SAE reporting (ensuring timelines). • Maintained and updated Trial Master File, Test Inventory Logs, close out visit etc.• Ensured that the investigator and site staff are adequately trained on protocol requirements, the investigational product, regulatory and ethical obligations.

India

Dispensing Medications: Accurately dispensed prescription medications to patients according to physician's orders and ensured the correct dosage, instructions, and medication interactions.Medication Counseling: Provided essential information to patients about their medications, including proper usage, potential side effects, and interactions with other drugs or food and also addressed patients' questions and concerns, offering guidance for optimal medication adherence.Patient Consultations: Offered one-on-one consultations with patients to discuss their health conditions, medication therapy, and any related concerns and provided recommendations for over-the-counter (OTC) medications as well.Prescription Verification: Reviewed prescriptions from healthcare providers to ensure accuracy and appropriateness and also contacted prescribers for clarification or to suggest alternative treatments when necessary.Inventory Management: Managed the inventory of medications and supplies in the pharmacy. This involves ordering, receiving, and stocking medications, as well as monitoring expiration dates and ensuring proper storage conditions.

Postgraduate Degree, Clinical Research

Bachelor'S Degree, Pharmacy