Resume : Clinical Research, Clinical Trail Associate

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Resume :
Pankaj Kumar Verman
Email : verman.pankaj AT gmail.com

Career Objective :
To maximize the potentials and utilize them effectively to attain organizational goals and objectives through positive attitude, flexibility and an open mindset. To enhance knowledge for professional growth in the field of Clinical Research and elevate to higher achievements in career and procure responsibilities that account on the basis of performance and diligent work.

Work Experience :
Current Position : Clinical Research Associate-I
Position Company Duration :
Clinical research Associate-I CATO Research Neuland India, Hyderabad Jan 2011 to date
Clinical Research Associate Division of Clinical Trials (SJRI), Bangalore Sep 2008 to Jan 2011
Clinical Research coordinator Victoria Hospital July 2007 to Sep 2008

Summary of Therapeutic Experience :
Position/ Role Therapeutic Area Indication Phase Duration Study Information :
CRA-I Nephrology AKI Observational Study Jan 11 to date 4 sites
CRA
Cardiology CVD IIIb/IV Dec 09 to Jan 11 Phase III, 26 sites
CRA
Cardiology Hypertension IV Nov 08 to Dec 2009 Phase IV, 11 sites
CRA Cardiology CVD III Oct 08 to Jan 11 Phase II- study -23 sites
CRC Dermatology Acne III July 07 to Sep 08 Phase III, 46 subjects

Current Employment History and Job profile :
Company : CATO Research Neuland India: Jan 2011 to date
CRA- Clinical Research Associate-I : Jan 2011 to date
Studies :
1. Nephrology – Observational Study on Acute Kidney Injury; CRA for 4 sites in India : Jan 2011 to date.
Job Profile :
- Provide functional assistance to project team members with administrative, logistical and practical issues including collection, distribution and fling of the study documentation.
- Supervise collection of ongoing study data for the purpose of regular project status reporting
- Review study related documentation for compliance with SOP and ICH GCP guidelines
- Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.
- Follow-up sponsor’s requests for clarification; supplementary information; distribution of newsletters and review approval of protocol amendments, IB, revision. Etc
- Obtain key GCP documents prior to site initiation for appropriate filing and distribution.
- Maintain updated study site in in-house files for the duration of the study.
- Organise, process & track the investigator payment as per the agreement
- Regularly review the status of key documentation in the trial master files, in compliance with SOP and to facilitate satisfactory Audit inspection.
- Assist the project manager, clinical operation manager and senior CRA with the day to day running of the clinical studies
- Assist project manger in regulatory submission and manage drug distribution, accountability and destruction
- Ensure complete and thorough study drug reconciliation.
- Maintain regular and effective communication with project team to assure trial activities are coordinated with in the project timelines.
- Design and maintain project status trackers for easy operation of the study.
- Manage site master file contents and work with sites to ensure communication requirements between site and IRB are adhered to.
- Initiate and follow-up through the formal process for the sites/investigator selection and clinical trial review by the appropriate authorities.
- Visit study sites periodically, to assess the progress of the study completion and verification of study data and patient records; accountability of the trial material; compliance with study procedures, GCP and for safety monitoring.
- Independently perform site evaluation, Initiation, interim monitoring close out visit for the phase III-IV studies as well as attend site audits for the assigned sites
- Manage trip reports, letters, query resolutions and expenses.

Previous Employment History :
1. Clinical Research Associate : - St. John’s Research Institute; period September 2008 to Jan 2011
Two and half years experience in St. John’s Research Institute, Bangalore. During the period, I had been involved in three cardiology study (Phase II, III and IV).
i. Cardiology – Phase III on CVD; CRA for 12 sites in India : Dec 2009 to date, 24 Monitoring visit, 6 Initiation visit.
ii. Cardiology – Phase II on CVD; CRA for 3 sites in India : Nov 2008 to April 2009, 3 Monitoring visit
iii. Cardiology –Phase IV on Hypertension; CRA for 11 sites in India : Nov 2008 to Dec 2009, 44 monitoring visit, 11 close out and 5 initiation visit

2. Clinical Research Coordinator- Victoria Hospital, Bangalore; period : July 2007 to Sep 2008
One years of experience in Victoria hospitals, Bangalore, India. During my period, I have been involved in clinical trials in the Acne (Dermatology) indication.
Job Profile :
- Maintenance of study related documents
- Maintenance of stock of the study related materials and goods
- Receiving and dispensing study medication to the subjects
- Maintenance of study screening logs, drug accountability log, Temperature log and other study related logs
- Updating case report file
- Internal site monitoring

Educational Qualification :
Course University Collage Year of passing :
Master in Clinical Research Cranfield University ICRI, Bangalore 2008
Bachelor in Biotechnology Bangalore University AMC, Bangalore 2006

Key Achievements :
Design Project status tracker : Design and maintain project status trackers for easy operation of the study in excel sheet to facilitate to track the study progress which will track individual subject visits, subjects enrolment status, drug accountability, AE/SAEs and also a consolidated study progress status (Total subjects screened, enrolled, total screened fail, total completed, total withdrawal etc)

Technical Skills :
Operating System : Windows
Office tool : Word, Excel, Power Point
Data Management Tools : SQL, InForm & IDataFax

Declaration :
I hereby declare and confirm that above mentioned information is true to best of my knowledge.

Date :
Place :Hyderabad

[swethas031@gmail.com]

CURRICULUM VITAE :
D.SWETHA
Email : swethas031 AT gmail.com

Career Objective :
To seek a challenging career that provides a chance to learn and that allows application of my knowledge and skills acquired through my education and project study.

Academic Qualifications :
COURSE YEAR OF PASSING NAME OF INSTITUTUON NAME OF UNIVERSITY PERCENTAGE SECURED:
B-Pharmacy 2011 St. Johns college of Pharmaceutical Sciences, Yemmiganur JNTU Anantapur, Anantapur 72.51
Intermediate 2007 Basireddy Junior College, Nandikotkur. Board of Intermediate AP 81.2
S.S.C 2005 ZPPH School, Konidela Board of Secondary Education.AP
78.5

IT Proficiency :
Operating Systems : Windows XP/2007
Application Skills : MS.Office 2003 and 2007

Strengths :
1. Flexibility to work in a team combined with positive approach and attitude.
2. Interest in continuing education and learning new skills.

Project Details :
I had successfully completed about industrial training for one month in Granules India Limited,Banjarahills,Hyderabad .
Title : "FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF NATURAL GUM BASED COLON TARGETED DRUG DELIVERY SYSTEM OF ALBENDAZOLE"
Brief Report : Albendazole, an antihelmentetic drug, has its site of action of in Colon. Conventional dosage form of the drug requires high dose at the cost of many side effects to achieve the required therapeutic effect. By designing a dosage form which can target the drug only to colon, bioavailability can be improved and thereby, side effects and adverse effects of the drug on body can be minimized. Hence, an attempt was made to formulate solid dosage form of Albendazole, specifically targeting to Colon. Various natural gums like Acacia, Tragacanth, Xanthan, Karaya, Kondagogu, Tamarind seed polysaccharide etc were used alone and in combination to control the release of drug over a period of time in Colon. Tablets were coated with pH dependent polymers like Eudragit to achieve colon targeting. Formulated delivery system was evaluated for various parameters in in-vitro conditions.