CRA

Sep ****-Till date

ORGANIZATION : P&N DRUGS

ROLE 1 : PHARMACY INTERN

Responsibilities

• Interprets and assesses orders; prepares, compounds, and dispenses medications. Provides drug information to practitioners and patients.

• Participates in quality improvement and medication use review activities.

• Contributes to the effective operation of the department by filing, restocking, answering the telephone and window, and making deliveries. Reviews listings on the patient Medication Administration Record and pharmacy profile and provides information to pharmacists for reconciliation. Processes patient charges and credits.

• Advice medication therapies

• Dispense medicine

• Patient counseling

Jan 2008-Jul 2010

ORGANIZATION : GLAXOSMITHKLINE PHARMACEUTICALS LTD.

ROLE 1 : CLINICAL RESEARCH ASSOCIATE

Experience

EGF110656 (LOGiC): Phase III Trial, Therapy Area: Esophageal

and Gastro-Esophageal cancer- Oncology

Study conduct – Site Initiation / monitoring (7 sites)

EGF 106708 (ALTTO): Phase III Trial, Therapy Area:

Breast cancer-Oncology

Study Conduct- Monitoring (2 sites)

SND 103288: Phase IIa Trial, Therapy Area : Neurosciences

Study conduct – Monitoring for 5 sites, close out & Archiving

SND 103285: Phase IIa Trial, Therapy Area : Neurosciences

Study conduct – Monitoring for 4 sites, close out & Archiving

Responsibilities

Site Development:

• Investigator selection, feasibility & pre-study assessment for sites.

• locating and assessing the suitability of facilities at a study centre;

• Assists in organizing and make presentations at investigators meetings.

• Cultivate and maintain strong working relationships & communication with key investigators and sites.

• Managing regulatory authority applications and approvals & coordinating with the ethics committee

Site set-up:

• Responsible for activating the site, conducting site initiation visits. & review protocols, CRF, & financial /regulatory documents with investigators to assure understanding of all study requirements.

• Providing necessary SOP’s training to site personnel on study conduct to trial specific and industry standards;

• Coordinated the supply of site materials needed for timely implementation & completion of assigned study.

• Negotiate revisions to investigators agreements and /or budgets as needed.

• Assist in developing recruitment packages for patients.

Site Monitoring:

• Performs site visits and ensure that quality data is generated, verified source data on patients, safety, and drug usage data and sites follow protocol & GCP.

• Monitor data resolution queries and EDC activities as needed.

• Taken lead role in the development and implementation of efficient and effective approaches to study site management (e.g; Training co-workers, coaching/mentoring staff; leading efforts to cross-therapeutic uptake of best practices for study conduct and site management.

• Resolved complex monitoring and regulatory issues through leading the discussion with site staff, project staff, or other GSK dept. , as appropriate.

• Motivate site personnel regarding patient recruitment and overall performance quality to ensure outcomes meets GSK expectations

• Monitor & document study activities and investigators status/progress at study sites to assure compliance with protocol, regulations & SOPs.

• Monitor & track clinical trial progress & record patient enrollment status in designated tracking system.

• Manage study/project budgets ensuring standardized spreadsheets are updated meeting study management timelines.

Site closeout:

• Conduct close out visits, providing needed training to site personnel regarding post-study activities

• Ensure completeness of study data & conduct final site evaluations confirms the storage of the documents at the site.

• Reconcile drug supply inventory usage.

• Archiving of the In-house files centrally.

ROLE 2: HUB TRAK EXPERT

• To set up all facilities in a site so that they will be model sites

• To develop new sites and give them adequate support

• To develop sites in all specialties in GSK India

Oct2006 - July 2007: PROGRAM LEAD

HIV and Human Development Resource Network (HDRN), Worked exclusively for United Nations Development Program for Prevention of Trafficking and HIV/AIDS (TAHA)

• Design and execution of the project.

• Leading a team of 7 Program Coordinators supporting and effectively guiding them.

• Creating interface between Doctors and the community (infected and vulnerable to HIV).

• Consenting individuals before enrolling in to the program.

• Experience in monitoring the progress of project in 7 centers and documenting the initiatives, meetings and process.

• Preparation of the budget.

• Coordinating with Sate Aids Control Society for the TAHA project , United Nation Development Program and HDRN.

• Constant assessment of progress and feedback to the organization.

• Collection of data and preparation of the report.

Jan2006 - Oct 2006: PROGRAM COORDINATOR

India Center for Social Change, Kottayam, Kerala.

• Developing situation analysis, program strategies, evolving systems and processing community participation and sustainability.

• Established linkages with organizations and training of program assistants.

• Sourcing and editing of Internet portal.

Dec2003 - Sep2004: VOLUNTEER

Positives Association Network Erode, India and Sneha Positive Faces, Coimbatore, India.

• Organized medical camps and conducted patient counseling and AIDS awareness.

• Was associated with these organizations in administering questionnaires.

May 2004 - June 2004 Preceptor Ship Program

Undergone. The Johns Hopkins HIV Preceptor ship Program. John Hopkins University School of Public Health, Baltimore, MD, U.S.A.

• Johns Hopkins Local Performance site Pennsylvanian Mid-Atlantic Aids education and training program.

• Translated the MOS-HIV (Medical Outcome Study) (Bloomberg school of Public Health questionnaire ) survey tools into the regional language Tamil

Nov2002-Nov2004: PHARMACIST

Udhaya Pharmacy, Avinashi Road, Coimbatore, India.

• Work experience as a Pharmacist dispensing drugs.

• Experience in providing patient counseling.

• Outstanding communication skills articulate in person.

Dec2002 - Sep2004 TRAINEE CLINICAL PHARMACIST

Departments of General Medicine and Pulmonology, Sri Ramakrishna Hospital, Coimbatore, India.

• Participated in the clinic patient rounds and monitored HIV and tuberculosis patient adverse drug reactions and drug interactions.

• Counseled and enrolled patients in phase four clinical trial programs and informed patients about the usage of spacer and other devices.

• Participated in outreach medical camps, dispensing medicines and conducting community education activities using multi-visual educational aids and techniques.

May 2002-Dec2002 PHYSICIAN REPRESENTATIVE

Dr Reddy’s Research Laboratories Inc.

• Liaised with Physicians and other medical professionals launched new products and organized public educational workshops. Experience in liaising with medical professionals and chemists, launching new products and organizing camps and awareness program among the public.

EDUCATIONAL QUALIFICATIONS

MASTER OF PHARMACY (Pharmacy Practice) (2002-2004)

Dr M.G.R Medical University, Chennai

SUBJECT SPECIALIZED

- Pharmacotherapeutics including Pathophysiology

- Hospital and Community Pharmacy

- Clinical Pharmacy

PROJECT

• Assessment of response towards highly active Anti retroviral therapy based on CD4 count and viral load. (This paper was presented at the 56th Indian Pharmaceutical Congress, Kolkatta, India.)

• Assessment of quality of life in HIV+ and HIV- individuals using Medical Outcome Study-HIV (MOS-HIV) questioner.

• Clinical utilization analysis in HIV/AIDS patients who are not on anti retroviral therapy.

Research Thesis: Assessment of patient response towards highly active anti-retroviral therapy (HAART) based on CD4 count and subsequent analysis of quality of life in HIV positives. The population covered here had Tuberculosis as the most common opportunistic infection.

A Retrospective study on HIV positive individuals undergoing HAART. Patients CD4 count and viral load were monitored and quality of life evaluated using a MOS (Medical Outcome study) HIV survey questionnaire.

BACHELOR OF PHARMACY (1997-2002)

Dr MGR Medical University, Chennai

PROJECT

• Study of Prescription Pattern and Adverse Drug Reaction of a private hospital.

Computer Skills: Ms Word, Excel, PowerPoint and Internet.

INTERNATIONAL PUBLICATIONS

• AIDS CANADA 2006: “Health related quality of life among HIV/AIDS patients on therapy and who are not on therapy” paper accepted at International Aids Conference, Canada 2006.

SPECIALISED TRAINING

Advanced Monitoring at GSK, Singapore – Dec 2008

Training on MS Project by Pragati Software Pvt Ltd. – July 2008

Training on Monitoring & ICH GCP at GSK, United Kingdom – Feb 2008

The Johns Hopkins HIV Preceptor ship Program. John Hopkins University School of Public Health, Baltimore, MD, U.S.A.

EXTRACURRICULAR ACTIVITIES

• Organized cultural program.

• Participated in the AIDS awareness run.

• Active participant in various sports activities like Badminton, cricket and soccer.

KEY STRENGTHS

• A good team player.

• Can work independently

• Reliable, hardworking, analytical and focused

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