SKILLS

Have fundamental knowledge of GDP, GCP, GLP guidelines and FDA, CDSCO, ANVISA regulatory guidelines.

Worked on BA/BE study & Phase I-IV Drug Development studies.

Proficient in Microsoft Office word, Excel, Power Point.

WORK EXPERIENCE

In-House CRA Oct 2012 – Apr 2015

Accutest Research Laboratories Pvt. Ltd.

Developed study/site start-up plan and manages efficient site start-up by coordinating submission of documentation to the Institutional Review Board (IRB), prioritizing contract completion with Outsourcing, and projecting status for Site Initiation Visits (SIVs).

Coordinated with the Site staff & Project Manager for planning of study schedule.

Responsible for the preparation and the review of study material, encompassing Protocols, Informed Consent Document, Case Report Forms (CRFs), Enrolment Logs, and their IRB/IEC submission.

Monitored the study to ensure that the study is conducted as per regulatory guidelines, IEC/IRB approved Protocol, ICH-GCP, and in-house SOPs.

Complete maintenance of the TMF including the tracking essential documents, ensuring all the study documents available as per TMF checklist, ICH-GCP, in-house SOP and regulatory guidelines for clinic/facility visit and Audit.

Led the Study team meetings which includes the developing the agenda and taking minutes of meeting and the issues are followed through until it is resolved.

Reviewed the documents to authorize the release of investigational product (IP) to study sites.

Handled the Investigational product (Verification and accountability of IPs, dispensing, reconciliation and return).

Reported AE/SAEs and safety reports to IRB/IEC and Sponsor.

Provided the support for the audits / inspections by organizing and maintaining the clinical study documentation including preparation for internal/external audits, final reconciliation and archival.

Patient Care- Intern May 2015 – Aug 2016

Phoenix Institute of Critical care

Discussed and worked with the physicians regarding clarifications and accuracy of prescriptions

Worked closely with the doctors, Nurses and hospital pharmacist for patient care.

Checked the medication reports of patients.

Regularly followed up for the treatment and dose of the patients.

Facility Revenue Cycle Specialist Jun 2019– Present

Pharmscript LLC, Somerset, NJ

The Facility Billing Specialist ensures that all outstanding bills are tracked for daily census

Responsible for entering and tracking all daily census and face sheets from Beneficiary Facilities for correct Billing to Medicare, Medicaid, and Private Insurances.

Responsible end of the month for billing to generate correct facility patient invoices.

Contacting the facility on the status of Medicaid pending residents.

Pharmacy Technician- Customer Service Representative Jul 2018– Jun 2019

Pharmscript LLC, Somerset, NJ

Discussed and worked with the physicians regarding clarifications and accuracy of prescriptions

Maintained computerized inventory control, computer systems and office administration.

Triaging of incoming phone calls from Nursing Facilities

Providing status or confirmation of medication delivery

Coordinated the Medication Orders both via fax and by electronic interface

Pharmacy Technician Feb 2018 – Jul 2018

Ace Pharmacy, Long Branch, NJ

Receive, verify and data entry of prescription.

Price and fill prescriptions.

Obtain approval from the pharmacist. Patient paperwork and Insurance claims.

Specialty Patient Interaction. (patient initial enrollment phone calls, refill reminder calls)

Managing inventory and stock of medicine.

ACADEMIC CREDENTIALS

Gujarat Technological University, Ahmedabad, India

Master of Pharmacy in Pharmacology& Toxicology Aug 2010 - Jul 2012

Hemchandracharya North Gujarat University, Patan, India

Bachelor of pharmacy Jul 2006 - May 2010

Medtech College, Atlanta, GA

Medical Assistance (27 Credits Completed) Oct 2016 – Apr 2017

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