Quality Assurance Clinical Research

HARDIK K BHALODIYA

B-** , shuklanagar society,waghodiya road

vadodara, gujarat 390025

Cell: +919*********

E-Mail: ***************@*****.***

Professional Summary

To Work Meticulously, Achieve Immense Growth and Success in My Career Where I can Contribute My Knowledge and Skills for the Growth of Organization, Team and Self, Which Gives an Opportunity for Better Learning and To Excel as a Leader in the Field of Clinical Research.

Summary of Skills

Clinical Trials

Clinical Quality Assurance

BA/BE Study

pharmacovigilance

Clinical Data Management

Experience

March 2011 to Current

shree krishna hospital karmasad, gujarat/india

clinical research coordinator

??? Trained on ICH-GCP, Schedule Y, ICF Process, SAE reporting

May 2009 to February 2011

Gujarat Liqui Pharmacaps (P) Ltd baroda, gujarat

production chemist

Handling of Manpower Independently.

Monitoring of all manufacturing activity and co-ordinate with other department.

Documentation of BMR as per cGMP.

Education

2009 SVKM'S NMIMS University mumbai, maharstra

M.PHARMA pharmacology

2007 Veer Narmad South Gujarat University surat, gujarat

B.PHARMA pharmcy

2003 Gujarat Secondary & Higher Secondary Education Board baroda, gujarat

science 12th

GUJARAT UNIVERSITY SURAT, GUJARAT.

GUJARAT - 390025

Professional Affiliations

Hardik bhalodiya. M.pharma (pharmacology)

Work History

March 2011 to Current

SHREE KRISHNA HOSPITAL karmasad, gujarat

clinical research coordinator

Professional Value Offered

Coordination and Management Responsibility:-

Play an integral role in managing the overall site staff this involves human resource and logistical issues.

To assist Principal Investigator in filling up Site Feasibility Questionnaire and co ordinate with CRA as a part of site selection process.

Working in coordination with Principal Investigator and study team to conduct trial in accordance with protocol, ICH GCP and regulatory requirement.

Organize and participate in all clinical trial related activities including site qualification visit ,site initiation activities, site monitoring visit , site audit visit ,site close out visit etc

Maintaining the entire study related activity like assist PI for consenting, complete requisition form for blood samples, IVRS, drug dispensing etc.

Conducting the Patient Screening, Enrollment and regular follow up visit.

Direct the requisition, collection, labeling, storage, or shipment of specimens.

Site monitoring - Serve as point person at the clinical site for monitoring needs. Prepare monitoring visits to make sure monitors receive all necessary information during their visits

Completing of action item for the site monitoring visit and audits

Develop reporting mechanism for bringing critical and high priority issues to the investigators, study sponsors, and/or the monitors.

Coordinating with CRA/CTL/PM of CRO

Keep a track of and maintain all source documents related to the patient.

AE monitoring, reporting and follow up of study

Ensure timely and accurate transcription of information on paper case report forms (CRFs), and electronic CRFs.

Resolution of DCF

Maintain the study related logs ??? screening, enrolment, drug administration, temperature and other communication logs.

Updating the study related trackers.

In charge of Investigational Product, storing, dispensing, and tracking of the same.

Manage the accountability of the Clinical Trial Material at the site.

Site Development

Trained new coordinators

Regulatory Responsibility:

Maintain and Updated Investigator Site File including regulatory document at the clinical site

Coordinating with Ethics Committee - EC Submission and Approval (Initial and Amendment)

Maintain communication with Ethics Committee and take lead in reporting adverse events,protocol deviations, safety reports, and other items as directed by ICH guidelines and the Ethics Committee.

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