Clinical Research Training

DEEPSHIKHA VINAYAK

Contact No. - +91-954*******

e-mail - *****.*****@*****.***

OBJECTIVE:

To get a good place in such an organization, where I can have the opportunity to bring in the best in me and to give the optimum results effectively and efficiently. I would like to be a soluble part of the organization wherever I go.

HIGHER QUALIFICATION:

Worked as “Accreditation Coordinator” for NABH Accreditation of Integrity Ethics Committee (CHL Hospitals Ltd.) under the NABH Accreditation program of Ethics Committee.

Received NABH Accreditation for Integrity Ethics Committee (CHL Hospitals Ltd.) with validity of July 2018 - July 2021.

Completed P.G diploma course in Pre-clinical, clinical research, biostatistics and data management (2015-16) from PES University, Bangalore under Karnataka govt. (BTFS) program receiving fully-funded fellowships from DBT.

Completed internship in Himalaya Drug Company as a project trainee (may-sept 2016) in Clinical Pharmacology Dept., R&D division, Bangalore.

SUMMARY:

Goal oriented, dedicated and consistent.

Good in analysing issues and resolving them in a timely fashion.

Highly reliable on commitment and delivery.

ACADEMIC QUALIFICATION:

Examination passed

Board/University

Year

Percentage

Div

EC Coordinator

CHL Hospitals Ltd., Indore

Mar 2017- Till Date

Clinical Trial Assistant

CHL Hospitals Ltd., Indore

Mar 2017- July 2017

P.G diploma in clinical research

PES University

(BTFS)

2015-2016

SGPA-10/10

M.Sc Biotechnology

T.M.B.U, Bhagalpur

2008

75.0

1st

BSc.(H)

Chemistry

T.M.B.U, Bhagalpur

2004

62.62

1st

Intermediate

B.I.E.C, Patna

2001

62.11

1st

Matriculation

I.C.S.E, New Delhi

1999

77.83

1st

TECHNICAL SKILLS:

JOB SKILLS AS EC COORDINATOR

Check/verify documents received for EC approval,notification and acknowledgment for putting up in upcoming meeting

Drafted the meeting Agenda for upcoming EC meeting and its coordination

Preparation of presentation for EC monthly meeting

Drafting of Meeting Minutes with reference to the discussions in the EC meeting

Drafting of Approval letters for PI subject to approval/disapproval or defer for the reviewed study proposal

Skills for drafting EC SOPs

Daily updation of Letter Trackers & Updating Monthly and Yearly tracker

JOB SKILLS AS CLINICAL TRIAL ASSISTANT

Temperature monitoring and recording for the Study Drug (IMP) at room temperature & fridge and deep freezer (where applicable)

Coordinate for blood sample collection, centrifugation of samples, slide preparation, labeling & appropriate storage of sample as per requisition form for the trial patient visiting the site.

Coordination for sample pick-up with delegated courier service. Packing of ambient for courier

Practical knowledge of conduction of Clinical Trials and how a Study Coordinator performs & manages the Trial right from SIV, screening, randomization to last patient visit, etc

Coordination of OPD Registration for Study Patient Visit, Trained on destroying expired lab kits, procedure of Archival of study documents after completion of trial & Updating Quality Indicator Sheets

OTHER SKILLS OF CLINICAL RESEARCH

Working knowledge in medical Writing (Protocol, Investigator’s brochures, Case Report Form preparation etc.).

Hands on training in Open Clinica.

CRF designing and annotation.

Knowledge of base SAS programming.

Knowledge of ICH-GCP.

Knowledge of Statistics and data management.

Agarose gel electrophoresis, isolation of plasmid DNA, spectrophotometric techniques, restriction digestion of plasmid DNA, PCR, cDNA Library construction, Isolation of genomic DNA.

CLINICAL TRIAL EXPERIENCE:

Indication of trial

Clinical Phase of trial

Role in the trial

Year of conduct of trial

Prostate Cancer

IV

CTA & EC Coordinator

Mar 2017 - Ongoing

Hormone receptor positive, HER2 -ve Metastatic Breast Cancer

III

CTA & EC Coordinator

Aug 2016 – Sep 2017

Type II Diabetes

III

CTA & EC Coordinator

Nov 2017 - Ongoing

Type I Diabetes

III

CTA & EC Coordinator

Jul 2016 – Nov 2017

Diabetes (Observational)

IV

CTA & EC Coordinator

Sep 2015 – Ongoing

ONLINE CERTIFICATE COURSES:

Certificate of Participation in GCP Workshop/Training organized by CTQUEST LLP. at CHL Hospitals Ltd., Indore on 19 May 2018

Certificate of participation for Webinar on “Key changes & Impact ICH GCP E6 R2” organized by Indian Society for Clinical Research on 15 September 2017

Participated in Workshop-cum-Training programme on Pharmacovigilance for NABH Accredited Hospitals organized by Pharmacovigilance programme of India (PvPI), IPC, Ministry of Health & Family Welfare (Govt. Of India)

IATA Training [Mayo Laboratories] - 27 March 2017

Online GCP Training [NIDA Clinical Trials Network] - 25 March 2017

NIH Training on “Protecting Human Research Participants” - 29 March 2017

Certificate Course: Essential Elements of Ethics - 17 April 2017

Online training certificate course: Research Ethics - 11 May 2017

Online training certificate course: Introduction to Informed Consent - 11 May 2017

Certificate Course: Introduction to collecting and reporting Adverse Events in Clinical Research - 12 May 2017

Certificate Course: How to conduct GCP Inspection/Audits at the Clinical Investigator Site - 12 May 2017

Understanding clinical research: Behind the statistics (Coursera)

Epidemics-the dynamics of infectious diseases (Coursera)

Epidemiology: the basic science of public health (Coursera)

EXPERIENCE:

Teaching experience of 1.4 yrs in St. Joseph School, 2011-12(senior secondary).

TRAINING/PROJECTS:

Self-trained on ICMR guidelines

Self-trained on Schedule Y of D&C Act and subsequent amendments

Self-trained on NABH Standards for Accreditation of Ethics Committee

Completed Internship as project trainee in Himalaya Drug Company, Bangalore, 2016 and got exposed to different aspect of Clinical Research Training.

Undergone M.Sc Dissertation programme (Jan- July 08) from CIMAP (Central institute of Medicinal and Aromatic Plants, Lucknow) under the guidance of Dr. Vikrant Gupta, Scientist E1, On “Sequencing and Analysis of ESTs from Trichome cDNA Library of Artemisia annua”.

TRAITS:

Positive attitude.

Time Management.

Fast learner and Keen observer.

PERSONAL DETAILS:

Husband’s name: Dr. Ranjan Kumar

Date of Birth: 18-07-1981

Languages Known: English and Hindi

Marital status: Married

Address: House no.-77, Umesh Nagar, Annapurna Road, Indore,

Madhya Pradesh-452009

DECLARATION: I hereby declare that the above details are true to the best of my knowledge.

Deepshikha Vinayak

Place- Indore Date- 22-10-18

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