Clinical Research Executive

Priya Raina

Contact: 853*******, 762*******

Email: ac8e05@r.postjobfree.com

Executive Summary

Accomplished career growth close to 4 years’ experience in Clinical

Research Coordinator, Lab Executive and eTMF activities.

Currently working as Associate-eTMF Process Management/D2 Tool management.

Diploma in Clinical Research and Clinical Data Management.

Publication in NCBI (Kocuria Sp

Certification in Good Clinical Practices and Regulatory Affairs. Work Experience Executive Summary

Atos Syntel Private Limited

Associate (April 2017-Till Date)

End to end activities on Electronic trial master file (e-TMF).Also working on D2 tool for importing the Clinical documents/Medical Devices Documents.

Closely working on close out activities and adhere the time lines of customers to deliver the export of trial master file.

TMF process management and QC documents, which have imported in tool.

Responsible for performing daily support activities ensuring that trial master file is complaint and ready for inspection.

Functions include TMF setup, Managing TMF file structures and archiving of TMF, e- TMF Query resolution. e-TMF user support and training and assisting with the oversight of the e-TMF Vendor.

Performing the Quality Control Review. Meet the regulatory requirement and ICH- GCP guidelines.

Updating weekly trackers and adhered on 100% compliance.

Develops strategies in co-ordination with Team leads and operations Managers so as to meet quality requirements efficiently and meet timelines set by the client. As Lab Executive in Jeevan Pathology and Laboratory Lab Executive (6 June 2016-10 April 2017)

Used highly technical machinery in lab for diagnostic purpose.

Collect samples, study and perform test on body fluids or biological specimen by using various types of machinery, lab equipment to perform test.

Hands on experience on machines like Centrifuge machine, PCR, UV machine. As Clinical Research Coordinator-Jehangir Clinical Development Center Clinical Research Coordinator (December 2014-May 2016)

Hands on experience on Tools like CTMS, INFORM, IWRS, RAVE etc.

Database Management /AS- SAE Management.

Maintain Site Specific File.

Preparation of ISF

Responsible for ICF & source documentation/ Data management / Filing & storage

of confidential patient records for the trials delegated.

Entering the patient data in EDC.

Compilation and maintenance of trial Master files, investigator study files and pharmacy study files according to current SOP’s.

Reviewing lab reports, Patient data, and Eligibility data for trial patients.

Also writing source notes for trial patients who have participated in a trial.

Also writing case narratives for patients having Serious Adverse Effect

Preparation of IEC / CEC submissions. Approvals and Notifications to ensure that a

trial is initiated at the site only after the approval of all necessary documents.

Investigational product: Management of proper storage, ensuring adequate drug inventory, track accountability of IP at site.

Attends Investigator/Study Start-Up Meetings As Requested By Sponsor and/or Physicians.

As QA Intern-Jehangir Clinical Development Center (September 2014-December 2014)

Working closely with Quality head for effective implementation of the QA plan.

Training of staff as per the QA SOP’s.

Review of study documents as per the QA plan.

Implementation and maintenance of quality management system standard. List of Clinical Research Studies worked on:

No. Phase Indication Role

1 IV

Type II diabetes mellitus Acne

Clinical Research Coordinator

vulgaris

2 III Acne vulgaris Clinical Research Coordinator

3 III Rheumatoid Arthritis

Clinical Research Coordinator

4 III Growth Hormone deficient Clinical Research Coordinator 5 I Glycemic index Clinical Research Coordinator

6 III Androgenetic Alopecia Clinical Research Coordinator 7

Observational

Constipation Clinical Research Coordinator

Study

Technical Qualification:

MS Office Tools (MS Word, MS Excel, Power Point and MS Access)

Rave Data base, Inform, Oracle, eCTD

IVRS/IWRS

base Bioinformatics Tools(BLAST and FASTA, Clustal W, Swiss Prot Protein Knowledge ExPASy Proteomics Server& Protein-Protein Interaction Studies. Academic Credentials

Degree Board/University Year Of Passing Grade

Diploma in Clinical Jehangir Clinical 2014 80%

Research & CDM Research Center Pvt.

Ltd.

MSc. Biotechnology Pune 2013 65%

BSc Biotechnology Pune 2011 58%

HSC J&K Board 2008 60%

SSC J&K Board 2006 75%

Personal Details:

Name Priya Raina

Father's Name Mr. Roshan Lal Raina

Languages Known English, Marathi & Hindi

Address Flat No. 101, Tirumati Apartment, Dhanori, Pune, Maharashtra Declaration:

I hereby declare that the above written particulars are true to the best of my knowledge and belief.

Place: Pune Name: Priya Raina

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