Customer Service Project

CURRICULUM VITAE

Priya Reshma Pinto,

*A **, ‘Mohana’ Block,

Nandi Gardens, Avalahalli,

Anjanapura post,

Bangalore 62

Contact: +91-988*******

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

OBJECTIVE:

Seeking Challenging and growth oriented position where I can develop and apply my knowledge

to work in a team or as individual to plan, design and properly implement the research activities

in assuring the best services to my ability to improve the efficiency of the organization.

Work Experience:

Worked as Team Leader for Clinical Trials (operations) in Department of Cardiology at

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St. John’s Hospital, Koramangala, Bangalore between Jan 2012-September 2012

Worked as Clinical Research Coordinator and Research Nurse in Department Of

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Cardiology at St. John’s Hospital, Koramangala, Bangalore between September 2011-

Dec 2011

Worked as Lecturer at Dayananda Sagar College of Nursing, Bangalore from July 2007 to

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September 2011

Worked as Staff Nurse at Bangalore Hospital, Bangalore. Feb 2004-Sept 2004

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Worked as Staff Nurse at Athena Hospital, Mangalore. Aug 2002-Dec 2003

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Trials Delegated:

1. Phase III. - Prevention of major cardiovascular events in elderly people.

2. Phase III. - Class II chronic systolic heart failure.

3. Phase III. - Prevention of thrombotic events in patients with history of myocardial

Infarction.

4. Phase III. - Pulmonary arterial hypertension.

5. Phase III. - Prevention of recurrent cardiovascular events among stable myocardial

infarction patients.

6. Phase III. - Secondary prevention of coronary events.

Nature of Job as Team Leader CRC

Maintaining Finance of clinical trials at site.

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Assisting Investigators for doing new feasibilities.

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Instructing and Helping CRC’s in relation with trials.

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Assisting PI during subjects Screening, Randomization, and during follow ups.

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Entering e-CRFs as per the source data & resolving the query generated by DM team.

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Narrating ICF process.

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Submitting trial related documents to EC.

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Reporting SAE to EC & CRO/Sponsor promptly.

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Coordinating with the Sponsor/CRO for any issues.

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Submitting Trial Status Report to EC on every six month.

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Maintain Trial Product accountability and Temperature log.

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Calling IVRS for Enrolment, Randomization, Drug acknowledgment etc.

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Tracking lab reports.

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Documenting study related procedures.

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SUMMARY OF KNOWLEDGE:

* Monitoring procedures.

* GCP and ICH guidelines including basic understanding of regulatory requirements.

* Clinical trial process.

* Standard Operating Procedures and Case Report Form.

EDUCATIONAL QUALIFICATION:

1. Master of Science in Clinical Research and Regulatory Affairs 2008-10, Sikkim Manipal

University.

2. PG Certificate in Diabetic Educator for Project HOPE – India Diabetes Educator Project.

3. Bachelor of Science in Nursing 2004-06, Rajiv Gandhi University of Health Sciences,

Bangalore.

4. Diploma in Nursing/Midwifery/Psychiatric Nursing 1999-2002, Directorate of Medical

Education, Karnataka.

CERTIFICATIONS:

1. The National Institutes of Health (NIH) Office of Extramural Research Web based

training course "Protecting Human Research Participants”.

Trained and received certificate on BioClinica Express 5.1.

2.

Good Clinical Practices from NIDA Clinical Trials Network.

3.

Certificate for completing the RDC Onsite training from Novatris.

4.

Certificate of Attendance for Oracle RDC 4.5.3/4.6

5.

Empowered Leadership Program from Center for Innovation & Leadership

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Organized seminar on Nursing Process in Dayananda Sagar college of Nursing.

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8. Attended workshop on Evidence based practice in Nursing from Dayananda Sagar

college of Nursing

9. Participated programme on Infection Control in Healthcare Setting by Indian Dental

Association

10. Attended workshop on Cardio-Pulmonary resuscitation by Dayananda Sagar college of

Nursing.

11. Received training in HIV/AIDS for Nurses from KIMS.

12. International English Language Testing System training from Global Strategic Staffing

solutions.

13. Attended the workshop on Current Concepts and Recent Trends in Clinical Specialties.

CLINICAL RESEARCH INTERNSHIP:

JS Science Research Center

Summary: Socially relevant medical and scientific research is being conducted to constantly

enrich the various health care and educational objectives.

Role: CRC Trainee

Duration: 2 Months

Responsibility:

*Conduct the clinical study according to applicable regulation and guidelines.

*Design and maintain organizational tools to conduct the study accurately and GCP compliance.

*Working with the institutional official in contract negotiations, developing a detailed cost

analysis.

*Recruit and screen potential study subjects according to protocol’s inclusion and exclusion

criteria.

*Ensure proper written informed consent from each study subject is obtained prior to

participation in the study.

*Ensure that the original signed and dated ICF for each subject with appropriate subject

identification is filed in the subject’s research record.

*Maintain adequate and accurate CRF for each study subject that records all observations and

data during the study.

*Complete the CRF for the study accurately and completely.

*Maintain all required documentation in the study file note book.

*Maintain records of study subject’s status in the study by using enrollment Log.

*Communicate with the sponsor/CRO regarding study activities as necessary.

*Submitting CRF’s and other data to the Sponsor as necessary and study closeout.

PROJECT DETAILS:

Title: Study of Investigational product for treatment of Type-2 Diabetes mellitus

Methodology: Treatment, Non-Randomized, Open Label, Safety/efficacy, cross-over assignment

Pharmacokinetics Study

Study Duration: 1 Year

University: Manipal University, Bangalore

COMPUTER SKILLS:

* Windows 2000, Windows XP/Vista, Microsoft Office.

SKILLS:

* Fluent in English and other local office languages both verbal and written.

* Able to work under optimal supervision

* Excellent organization, planning and problem solving abilities.

* Excellent analytical skills.

* Established interpersonal and communication skills.

PERSONAL ATTRIBUTES:

* Detail oriented

* Timeline driven

* Good listener

* Eager and fast learner

* Excellent communicator and customer service skills

* Work well in teams

* Analytical and respectful

* Transparent

PERSONAL DETAILS:

Date of Birth: 22-September-1981

Languages known: English, Hindi, Kannada, Konkani, Tulu

Reference:

DR. M J SANTHOSH, MD, DNB. (Cardio)

Associate Professor, Dept of Cardiology,

St John’s Medical College Hospital, Bangalore

Mob No: 098********/ Office: 080-********

Declaration:

I solemnly declare that the details furnished by me in this form are true and correct to the best of

my knowledge and belief.

(Priya Reshma Pinto)

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