Clinical research associate, Pharmacovigilance

Amardeep Patel

Phone No.: 856-***-****

Email: ************@*****.***

Career Objective:

To provide and sharpen my professional expertise to the organization I work

for building a healthy relationship and to gain wholesome growth in

consonance with the organization goal and for a win - win situation.

Professional Experience:

MedPlast, West Berlin NJ USA

Aug. 2014 to Present

Technician

. Set up machines at the beginning of shift to ensure proper working

order

. Perform testing procedures to ensure that machines work optimally

during the production procedures

. Calibrate machines at the beginning of the each shift

. Troubleshoot problems during machine operation

. Create and maintain activity logs

. Provide relevant information regarding progress to supervisors

GVK Bioscience.pvt.ltd (CRO), INDIA

Nov. 2012 to Mar. 2014

Clinical Research Assistant in BA/BE studies

Pre-Study:

. Preparation of Protocol, Inform Consent Document and CRF

. Ethic committee Submission

. Communicate with sponsor on all trial related issues

. Review of ICF and Protocol before submission of IEC and review of IEC

approval process

. Checking of study requirements before start of study

. Handle project related Investigational Products and its documentation

. Presentation of Informed Consent and obtaining consent

. Train the study team on project related activities

. Ensure arrangement of contractual staff

. Ensure proper initiation and conduct of the trial

. Compilation of raw document

During Study:

. Explanation and distribution of consent

. Monitoring of the clinical phase of the trial to ensure the trial is

being conducted in accordance with ICH-GCP, SOPs and Protocol

. Check all forms including consent forms

. Verification of dispensing labels and Vacationers labels.

. Verification of study file, essential documents, raw data and report

for data accuracy

. Coordination with clinical and QA team for data and report for data

accuracy

. Checking all logbooks related to project for completeness and

correctness of entries

. Assist the sponsor or sponsor's monitor during the clinical phase of

the trial

. Ensure proper documentation of Adverse Drug Reactions, Note to files,

Deviations etc.

. Performing online quality checks and online resolution of the findings

to avoid any discrepancy in data

. Co-ordinate QA audits

. Updating sponsor and ethics committee at regular interval regarding the

status of the trial

. Send clinical updates to all concerned

. Ensure subject contact during the washout period and follow-ups

. Sending interim update to Sponsor in case of long wash-out of study

drug

Post Study:

. Follow up of unresolved adverse events

. Review of Completed CRF

. Compile raw data and prepare report

. Resolve all QA queries in timely manner

. Handling the sponsor's audit and resolution of finding with appropriate

response

. Archiving of the documents as per in-house SOP

. Attend and participate in investigator's meetings

. 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

. Dosing.

. Monitoring the Sample.

. Check in and Check out the subject.

. Knowledge of basic computer.

. Conversant with Internet.

Three months of training in

Site 1) Sanjivani Super Specialty Hospital, Vastrapur, Ahmedabad

Site 2) Dr.Kamal Sharma Cardiology Clinic, Ahmedabad, India

Clinical Research Coordinator

. Submitting regulatory documents to IRB and Sponsor

. Submitting the clinical study agreement to OSP for review

. Attending investigator meeting(s)

. Developing a preliminary budget and verify all costs

. Helping PI negotiate the study budget direct costs with sponsor to

cover all costs (F&A costs are not negotiable)

. Preparing for study initiation

. Obtaining physician signatures

. Recruiting subjects

. Screening and scheduling subjects

. Getting voluntary subject consent

. Teaching subjects about protocol expectations for them

. Performing study/protocol procedures in a detailed, accurate manner

. Maintaining study files

. Tracking and maintaining the study budget and payments, including

invoicing the sponsor for completed work

. Tracking subjects, avoiding lost-to-follow-up

. Documenting an adverse event, including:

. describing the event

. severity and frequency

. treatment

. resolution

. Processing and shipping lab work

. Completing case report forms (CRA) for PI review and approval

. Helping study monitors with CRA corrections

. Maintaining study-specific supplies

. Preparing for study closure and archiving

Three months (500 hours) of training in CIVIL HOSPITAL at Petlad as a

Pharmacist

One month of training in VITAL FORMULATION LTD.at V.U.Nagar, India as a

Supervisor

Skills:

ICH-GCP, Schedule Y, US-FDA Guidelines, Pharmacovigilance, CRF-Review,

Monitoring, BA/BE studies

Educations, Licenses, and Certificates:

Qualification Institution Board/Univ. Year of Passing

APGD in Clinical IICR, Ahmedabad 2012

Research

Bachelor of NCP, Bangalore RGUHS, 2011

Pharmacy Bangalore,

India

Diploma of Pharmacy NCP, Bangalore Karnataka 2007

Board,

Bangalore,

India

Achievements:

. Successfully faced MOH (Turkey) audit from date November 30, 2012 to

December 1, 2012 in GVK Biosciences, Ahmedabad, India.

. Successfully faced DCGI audit on February 22, 2013 at GVK Biosciences,

Ahmedabad, India.

. Certificate of Participation Investigator's Meeting (WIPM-02) on August

04, 2012

. Certificate of Training for successful completion of ICH GCP,

Investigator's Responsibilities (WIPM-02) on August 04, 2012

Reference:

Available upon request[pic]

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