ETI Clinical Bangalore : Oncology, Clinical Research Associate

[mskavi]

ETI Clinical Bengaluru/Bangalore : Clinical Research Associate-CRA, ETI Clinical

Website: http://www.etiklinical.com/

Job Description:
Assessment, documentation and all QC and QA procedures at the investigational site and CRO.

Desired Candidate Profile:
a) Senior CRA - 3 yrs experience in Oncology.
b) CRAs - 2 Yrs experience in Oncology.
Salary is negotiable based on experience.

Company Profile:
ETI offers an exceptional mix of high-quality clinical research services, real-time data acquisition and personalized communication processes to manage a clinical trial from initial planning to approval, on time and on budget, every time.

Email Address: recruit@karlegroup.com

[Pinki]

CURRICULUM VITAE

Contact Details:
Pinki Mehta
Present Address: No26 • Ganesh Nilayam, A.N.Gupta Layout, Adugodi • Bangalore
Permanent Address: Sector 12/F, Qr No: 1223, Bokaro Steel City Mobile: 91-9342465964
• Email: pinkimehta2004@gmail.com

Core Strengths

· Clinical Research (Approx 2 yrs) with educational background.
· Approx 1 year of experience as a part clinical trials for Diabetes
· >1 year of experience in Oncology trials , mangaing sites and recruitment.
· Expertise with FDA/ICH-GCP regulations/guidelines for conduct of clinical trials.
· Experience of conducting >50 clinical trial monitoring visits.

Summary of Professional Experience

· Triesta Sciences (I) Pvt Ltd, Bangalore, India
Duration : March 08 onwards
Position / Title : Clinical Research Associate
· Novo Nordisk (I) Pvt Ltd, Delhi , NCR, India
Duration : Feb 07 – Dec 07
Position / Title : Clinical Research Associate

A. Project Management / Monitoring Experience


· Work Experience
Approx 2 years
· Monitoring Visits
14 – Site selection visits
36 – Site Initiation visits
50 -60 – Interim / Routine monitoring visits
15 – Site close out visits


Key Responsibilities:
· Delivery of high quality data according to agreed timelines and budget, ensuring adherence to protocol, international and local regulations and company SOP standards.
· Assist in preparation, negotiation and administration of study budgets and contracts with study sites, core labs and other participating institutions.
· Plan clinical strategy for vendor management & all trial logistics.
· Work with clinical teams to assist in development and review of study protocol, ICFs, CRFs, subject recruitment materials, study reference manuals and other study related documents.
· Assist in planning, preparation & organizing Investigator & coordinator Meet.
· Conduct study training or other formal training at site and at the study team level.
· Developing and maintaining trial management systems and trackers.
· Oversee and manage IEC submission.
· Prepare, plan, organize and conduct Site selection / Pre-study/ Initiation/Interim /close out visits.
· Study Essential Documents review and Maintaining Trial Master File.
· Assist in CRF Data transfer, Query generation & resolution.
· Facilitate AE / SAE Reporting.
· Generation and tracking of Investigator/ Site payments.
· Prepare & attend Sponsor Audit
· Mentoring Junior Staff.
· Helps in developing Lab SOPs & Perform Lab Qualification, Training, QC testing, Initiation, Proficiency Monitoring Visits.
· Assist in generation of monitoring plan, project-management reports and assisting in the preparation of clinical study reports.
· Maintaining constant communication with clinical sites and internal study teams.
· Participates in the development of and ongoing review of institution SOP’s and recommends new approaches, policies and procedures to effect continual improvements in the efficiency of the clinical department and performed services.
· A part of recruitment team for all sites and trials.


B. Site Management Experience

Work Experience : 1 year 3 months
Key Responsibilities:
· Coordinate with Sponsors to discuss new study protocols and determine its compatibility with respect to our investigators, patient pool, location & demographics.
· Financial negotiation with sponsors for finalizing CTA and budget.
· Serve as a Key Opinion Leader for all sites to determine safety and Protocol feasibility.
· Oversee and supervise professional staff with complete discretion over the daily operations of the studies managed at site.
· Assist Head of Clinical research with the preparation of all required Regulatory Documents prior to and during the study.
· Manage Quality Assurance of the clinical trials.
· Hire new employees & train them for specific functional roles.
· Conducting regular appraisals & recommending personnel actions.

Conducting trials for following Therapeutic Area Experience -

Therapeutic Area Indication Study Phase Role in Study
Oncology Breast Cancer Phase – II CRA
Oncology NSCLC with Cachexia Phase – III CRA
Oncology Prevention of thromboembolism in Pts. Undergoing Chemotherapy Phase – III CRA
Oncology Breakthrough Cancer Pain Phase – III CRA
Oncology Renal Cell Carcinoma Phase III CRA
Oncology NSCLC Phase II CRA
Oncology Multiple Myeloma Phase III CRA
Oncology Cancer and Events Involving Venous Thromboembolism Phase III
CRC Oncology NSCLC Phase III CRC
Endocrinology Diabetes Phase III CRA
Endocrinology Diabetes Phase – IV CRA

Professional Qualification
Ø M.Sc in Clinical Research (Aug 2005 – Aug 2007)
College : Institute of Clinical Research (India), New Delhi
University : Cranfield University, UK
*Earned Scholarship in First Year of M.Sc. Clinical Research

Certifications / Training Programs Attended
Professional Memberships


In-House Training

· May 4 - May 19, 2007 – Convened by Clinical Research Academy.
· Oct 22 - Oct 27, 2007 - Convened by Clinical Research Academy.
· Jan 23 - Jan 25, 2008 - Convened by Clinical Research Academy.
· Basic techniques in Biotechnology – Scheffelin Leprosy Research and Training Centre , Tamil Nadu
· Training on veterinary medicine – Institute of Veterinary Preventive Medicine, Tamil Nadu

Computer Skills

Ø Programming Language: C
Ø MS Utilities: MS Excel, MS Word, MS Power Point
Ø Experience in Electronic Data Capturing, Data-Fax & IVRS
References

Available on Demand
Dated: May 26th , 2009

[Guest]

PURVA NEMAVARKAR
Email: pnemavarkar AT googlemail.com ; p.nemavarkar.s06 AT cranfield.ac.uk


CAREER OBJECTIVE:
Searching for challenging opportunities, to handle latest professional challenges in the area of Drug Discovery and clinical & pharmaceutical research/healthcare, immaculately, with the goal to achieve professional excellence through hard work and perseverance.


WORK EXPERIENCE
April 2009-September 2009

MSc project-(Translational Medicine) - Primrose Oncology Research Unit, Bedford Hospital, Bedford, UK -Part-Time.

Project Title: Designing of clinical trial for evaluation of Double blind randomised study of a complementary versus standard aqueous cream for Capecitabine induced hand foot syndrome. Supervisor: Dr Robert Thomas, Consultant Cancer Specialist.
Position: Trainee Research Project Assistant.

Study objectives:
1> To measure the preferences of patients for the study design to evaluate the efficacy of a complementary cream, to prevent capecitabine induced Hand Foot Syndrome (HFS).
2> To compare the effectiveness of this complementary cream compared with a placebo.
3> Design and finalisation of clinical trial, based on pilot survey and questionnaires.
Work profile:
· Currently, assisting the Principal Coordinator for finalising the trial and protocol design, for submission to National Ethics committee, Bedford R & D, National Cancer Research Network.
· Designing of Case Record Forms for the trial.
· Scanning and tracking of CRF from previous studies.
· Constructed set of questionnaires, to gain the patient feedback for the best design. This was to ensure greater compliance of patients for an eventual trial.
· Submitted the questionnaires to ethics committee (NRES), for approval.
· Conducted casual 5-10 minutes discussion with patients within the Primrose Oncology Unit, to value their opinion on two possible designs for the study.
· Co-ordination with ethics and regulatory committee.
· Conducting the statistical analysis for the power calculations and endpoints determination.
· Carrying out general office and administrative work, involving collating the documents, scanning of CRF and checking their relevance.

Feb 2006-Feb 2007
Triumphant Institute of Management Studies, Bangalore, India
Position: Biology Faculty cum Assistant Administrator
· Imparted lectures in Biosciences (Oncology, Basics of clinical research, Molecular Biology and Plant Sciences)
· Coordinated and counselled students.
· Participated in general administrative activities.

May 2000-July 2005
Bhabha Atomic Research Centre - Mumbai University, India
Research Student, Radiation Biology & Health Sciences Division.
Thesis Project: Regulation of radiation response, DNA damage and Radioprotection in Yeast.
§ The project involved evaluating the efficacies of non toxic compounds to impart radioprotection to normal oxic cells during cancer radiotherapy, in the pre-clinical settings.
§ Careful manipulated the yeast cells to mimic mammalian hypoxic tumour cells, in culture.
§ Use of Single Cell Gel Electrophoresis (SCGE), cell survival, topoisomerase, SOD, catalase and lipid peroxidation assays for detection of radiation induced DNA and enzymatic damage and subsequent protection by radio-protectors.
§ The results were further extended to mouse fibrosarcoma model.

EDUCATION

2008-2009

Cranfield University, United Kingdom
M.Sc - Translational Medicine & Clinical research, Cranfield Health
Modules covered:
· Basic Pharmacology, Formulation Development and Drug Discovery
· Preclinical Evaluation-Lab Settings, Clinical Research Methodology (Phase 1-IV clinical Trials)
· ICH/GCP modules
· Clinical Data Management.
· Basic SAS Programming for clinical research.
· Regulatory requirements for Biologics and Medical Devices.
· Quality Control & Quality Assurance
· Good Laboratory Practices, Good Manufacturing Practices.
· Marketing interface (Risk Benefit ratio, Post Marketing Surveillance)
1997-1999
Mumbai University, India
M.Sc - Cytogenetics & Molecular Biology. Grade: Distinction (78%).

1994-1997
Mumbai University, India
B.Sc Biology. Grade: First class (68%)

COMPUTING SKILLS
· Basic SAS programming for Clinical Data Management, Cranfield University, UK. (Oct 2008-Feb 2009).
· Honours Diploma in Computing, NIIT, India, (1997-1998); Modules covered: MS office package, MS Access, Oracle database, C++.
AREA OF EXPERTISE

Clinical research:
o Basic pharmacology, including pharmacokinetics (ADME), drug toxicity testing and pharmacodynamics.
o Knowledge and understanding of clinical research methodology and GCP/ICH guidelines.
o Clinical drug Development (phase I-IV).
o Clinical trial monitoring.
o Protocol and CRF designing.
o Knowledge of Data capture methods, Data entry, Data validation, Query Management, Data storage and archival.
o Knowledge of Quality Systems - SOP’S & Audits, Regulations & guidelines for CDM and Safety Data Management.
o Knowledge and understanding of reporting serious adverse events, fraud and misconduct.
o Knowledge of Patient recruitment, informed consent, legal and ethical approval issues.
o Knowledge of Regulatory (EU and FDA) and QA environment for pharmaceuticals and medical devices.
o Knowledge of Quality control in clinical trials.
o Knowledge of GMP in regulated markets.
o Clear understanding of market research and ethics.

Biological skills:
· Efficient in Oncology, Microbiology, Molecular Biology, Gene Cloning and Immuno-Techniques.
· Good written and verbal communication skills with excellent organisational skills.

WORKSHOPS AND TRAINING (AT CRANFIELD HEALTH)
A) GCP Awareness and practice Workshop organised by QED Partnership, Milton Keynes, under guidance of Susan Ollier. (12th Jan-16th Jan, 2009).

B) Site Investigation Activity (26th Jan-30th Jan, 2009):
Evaluated the suitability of the Primrose Oncology Unit at Bedford Hospital for joining a multi-centre phase III trial, for investigating a new chemotherapy agent for breast cancer.

C) Evaluation of Promotional Materials: (9th Feb-13th Feb, 2009)
Participated in a case study conducted by Dr Alan Collin, Associate Director, Regulatory Affairs, and Allergan, UK.

D) Regulatory challenges of Combination Products, Dr Bryan Allman (9th-13th Feb, 2009)

PUBLICATIONS
P.J Vaidya and K. Pasupathy, 2001. Radioprotective action of Caffeine: Use of Saccharomyces cerevisiae as a test system. Indian. J. Exp. Biology, Vol: 39, 1254-1257.
P.S Nemavarkar, B.K Chourasia and K. Pasupathy, 2004. Radioprotective action of compounds: Use of yeast Saccharomyces cerevisiae. Journal of Enviornmental Pathology, Toxicology and Oncology, Vol: 23 (2), 145-151.
P.S Nemavarkar, B. K Chourasia and K. Pasupathy, 2004. Detection of gamma-radiation-induced DNA damage and radioprotection of compounds in yeast using Comet assay (SCGE). Journal of Radiation Research (JRR), Vol 45, 169-174.


REFERENCES- On request.

[Guest]

E-mail: sapna2yuva AT gmail.com
OBJECTIVE: To utilize my qualification and skills in an optimist way for the growth of the organization and reach its goals.

EDUCATIONAL QUALIFICATION:
COURSE SPECIFICATION INSTITUTE YEAR OF PASSING UNIVERSITY
MSc MICROBIOLOGY BRINDAVAN COLLEGE 2007 BANGALORE UNIVERSITY
BSc CBZ MAHARANI LAKSHMI AMMANNI COLLEGE FOR WOMEN 2005 BANGALORE UNIVERSITY
PUC PCMB MAHARANI LAKSHMI AMMANNI COLLEGE FOR WOMEN 2002 PRE-UNVERSITY EXAMINATION
SSLC St MARY’S GIRLS HIGH SCHOOL 2000 BOARD EXAMINATION

COMPUTER PROFICIENCY:
Utility :MS Office98,MS-EXCEL, MS Word

TYPING SKILLS :Passed junior typing.

PROJECT DETAILS:
Comparative study on the fermentation quality of different probiotic lactic cultures with enhanced therapeutic value. Under the guidelines of
Dr. A.M.Natarajan.

K.C Das Pvt Ltd,
Church Street
, MG Road
Bangalore- 560001.

DESCRIPTION:
Preparation of yoghurt using probiotic cultures like Lactobacilus casei, Lactobacilus acidophilus, and Bifidobacterium bifidum thereby enhancing their therapeutic values.
Fermentation represents one of the earliest biotechnological processes. Fermented foods have been a part of the Indian diet for long time.Lactobacillius sps. Bifidobacterium sps , Saccharomyces sps. and other species have been proposed as and are used as probiotic strains i.e. live micro organisms as food supplement in order to benefit health.These microbes are natural inhabitants in the human intestine, most probiotics do not permanently adhere in the intestine, but exert their effects as they metabolite and grow during their passage through the intestine.

Probiotic are useful in the treatment of many types of diarrhea,
Caused by rotavirus. They preserve intestinal integrity and mediate effects of inflammatory bowel diseases, irritable bowel syndrome and constipation, colitis and alcoholic liver disease. They improve digestion of lactose, enhance immume response and resistance to infection.

Hence, some of the probiotic fermented food products are yoghurt, Emmi, Misti dahi, etc

TRAINING:
Undergone training based on CLINICAL RESEARCH in MEDISYS CLINISEARCH PVT LTD under Dr. Paramesh Shamanna.
BANGALORE DIABETIC CENTRE
4C-426,4TH Cross 2nd Block,
Kalyana Nagar,
Bangalore-43

Job 1: Working as Clinical Research Coordinator in Bhagwan Mahaveer Jain Hospital under Principal Investigator- Dr.Mala Dharmalingam, Endocrinology Department.
Joined Date: - 12 May 2008 to till date.
Handling Trials:
1. A Randomized Double blind, Placebo and Active Comparator-controlled Parallel group Study of Efficacy and Safety of Study Drug as Monotherapy Treatment of Type 2 Diabetes Mellitus.
2. A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to evaluate the Efficacy and Safety of Study Drug in Combination with Metformin IR as Initial Therapy Compared to Study Drug Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control.
Job description:
Experience in Clinical Research:

- Preparation and subsequent submission of study related documents to the Ethics committee for approval.
- Conducting weekly medical camps in healthcare organizations in and around Bangalore.
- Experience in counseling and recruitment of patients.
- Coordinating between the site and sponsor/CRO and all activities related to the study within the site.
- Ensuring that study is going as per ICH & GCP guidelines and also the study protocol, SOP and other regulatory requirements.
- Maintenance of trial master files (patient screening log, patient enrollment log, drug accountability log, etc.).
- Filing the case report form [CRF/e-CRF (electronic)] by using source document and query
Management.
- Randomization of patients (through IVRS).
- Reporting the SAE to ethical committee and the sponsor
- Filling sample requisition forms of the patient.
- Shipping of samples to International and Local labs.

Current CTC: - Around Rs.10, 000 per month
Expected CTC: - Rs. 15,000-20,000.
Notice Period: - 1 month.
Key Strength : Excellent written and oral communication skills. Desire to learn and excel. Easily adaptable to new and challenging environment.

Strength:
Good inter-personal skills.
Participants in Social Service activities.
Hardworking and disciplined.
Honesty and confident in my work.

DECLARATION:

I hereby declare that the information given above is true and correct to the best of my belief & knowledge.

Date:
Place: Bangalore

[sajusajan]

Dear Sir/Madam,
This is a Job application for the clinical eserch field.
I am sajan P.A. I have studied

M.Sc in Biochemistry,

Professional Diploma in Clinical Research, and
P.G.Diploma in Bio informatics,

Currently waiting for the result of M.Phil (Biochemistry).

Presently I am working as a clinical research coordinator in St.John's research Institute from Jan 2008 to till date

Am confident that my qualifications, skills and past working experiences are relevant to the requirements in Clinicalresearch field.
My updatred Resume is attached for your review and I would appreciate the opportunity to discuss with you personally.
please consider my application for any post in clinical research field

Thank you for your time and consideration and I look forward to hearing from you.
.
Yours sincerely,
sajan Pushpamangalam.A.
9844550813
sajusajan AT gmail.com
Bangalore
India

[Pushpendra K. Sharma]

Respected Sir/Madam,
I, Pushpendra K. Sharma, completed the M. Pharmacy (Pharmacology) from AISSMS College of Pharmacy, Pune. I wish to apply as an employee in Preclinical/Clinical R&D, Regulatory officer executive or any other suitable field in your esteemed organization.
Your esteemed organization has significant contribution in Health care. If provided an opportunity, I will work hard to achieve organizational goals. My skills and personal attributes will effectively contribute to the team and organization and match the requirement you seek.
I have enclosed my detailed candidature for your kind attention and look forward for an opportunity to work in your renowned organization.
Thanking You.

Regards
Pushpendra K. Sharma
M.Pharm (Pharmacology)

[Guest]

Hi Madam/Sir,

I am a Clinical Research Associate in Glenmark Pharmaceuticals Ltd. India. I am having 3 Years and 4 months of experience in the field of Clinical research. Also I have 1 year Lectureship experience from Punjab Technical University, India and 6 months of laboratory research in molecular biology from IIT-Guahati, India. I am a Post graduate in Life Sciences, from Devi Ahilya University, Indore, M.P., India. I believe this experience would be useful to establish me for the referenced position.

I would not mind to relocate anywhere. I am fluent in English and Hindi languages.

I would be very happy to provide you further information to proceed my application. I would also welcome a chance to appear in person or to have some telephonic communication.
I am attaching here my resume for the same :
Rina Kumari
Flat # 208, A-Wing, Shivashakti C.H.S., Sector – 2, Airoli, Navi Mumbai- 400708
Mobile : +91 9987003175
E-mail id : rinadavv2k AT gmail.com
P r o f e s s i o n a l S u m m a r y
A Post Graduate in Life sciences with an experience of 03 yrs and 03 months in entire gamut of clinical research.
My strengths lie in striving towards self-development by always being on the learning curve thereby contributing to the organizations growth. To merge my talents with the knowledge acquired so far to achieve excellence at par.
P r o f e s s i o n a l E x p e r i e n c e
July 27, 2009- Till Date Glenmark Pharmaceuticals Ltd. (Glenmark Research Centre, Mahape, Navi Mumbai)
Designation : Sr. Clinical Research Associate
Job Responsibilities :
- Explore new prospective sites and conducting feasibility survey for the studies.
- Manage Investigators meeting.
- Assist Clinical Project Managers in study start-up activities, regulatory process and execution of study related agreements.
- Prepare and review study specific plans and guidelines.
- Prepare and review protocol synopsis and Informed Consent forms.
- Perform site Initiation, Monitoring and Close-out activities.
- Perform study compliance visit at CROs & sites.
- Maintain ongoing communications with sites to provide information, queries resolutions, and overall progress of clinical trials and adherence to established guidelines.
- Update Clinical Project Managers with the sites and subjects status.
- Coordinate with the team for study updates.
- Assists sites in adverse event reporting and recruitment strategies
- Maintain and update trial master files on regular basis; Responsible for ensuring compliance to GCP, ICH Guidelines, regulatory and internal requirements for clinical trial master file documents.
- Identifies, records and report quality problems to Clinical Project Managers.
- Suggests initiates, recommends and/or provides solutions as appropriate.
- Perform completion of study specific tasks (such as preparation/shipment of study file notebooks)
- Performs other study related tasks as assigned by Clinical Project managers.
- Assist QA in preparation and review of the Clinical operation SOPs and their associated documents.
- Assist Clinical Project managers in RFI and RFP process.
- Review monitoring visit reports and update Clinical Project Manager for any issues.
- Facilitates the resolution of study related issues through communication with site personnel and clinical trial vendors including central labs, monitoring CROs, etc.
- Assist in screening documents for compliance with protocol and appropriate regulations, assist in investigating incomplete, in accurate or missing documents to ensure accuracy and completeness of data.
- Clinical Research Experience :
Indication of the study / Disease Study Type and Phase Role in the Study
Type 2 Diabetes Mellitus A phase II, 12-week randomized, double blind, parallel group, placebo-controlled study to evaluate safety, tolerability and efficacy of GRC 8200, a new oral DPP-IV Inhibitor, in patients with Type 2 Diabetes Mellitus. – Global study
- CRA
Mild to moderate persistent asthma A phase II, 12-week randomized, double blind, parallel group, placebo-controlled dose range finding study to evaluate the efficacy of Oglemilast in the treatment of stable mild to moderate persistent asthma. – Global study
- CRA
Acute Infectious Diarrhea A double-Blind, Randomized, Four Arm, Dose Ranging (Phase IIb) Study to Assess the Efficacy, Safety and Tolerability of Crofelemer in the Treatment of Adult Acute Infectious Diarrhea. – Global study
- CRA
Phase I A Phase I, Single-Centre, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Evaluate the effect of Tedalinab on ECG parameters, CNS Function and pain perception in Healthy Subjects. (Utrecht, The Netherland)
- CRA
Phase I A Phase I, Randomized, Double-Blind, Placebo Controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability, Pharmacokinetics (with food effect) and Pharmacodynamics (Human Pain Models), Effect of single and multiple ascending doses of GRC- 15300 in Healthy male and subjects. (Middlesex, United Kingdom)
- CRA
Bioavailability study A randomized, open label, three way crossover relative bioavailability study in healthy adult male and subjects to evaluate the bioavailability of GRC- 4039 (1 mg and 5 mg) following single oral administration of a tablet formulation under fasting and fed conditions compared with that of a capsule in fasting condition.
- CRA
Oral Contraceptive A open label, prospective, multicentric post marketing surveillance study to assess the Safety of Oral Contraceptive containing Drospirenone & Ethinyl estradiol [ASMITA] on Quality of life - Phase IV Study
- CRA
Osteoporosis A open label, prospective, multicentric, single arm post marketing surveillance study to assess the Efficacy, Safety, and Quality of life in postmenopausal women with osteoporosis using salmon calcitonin nasal spray . - Phase IV Study
- CRA
May 2007- July 2009 Reliance Clinical Research Services (A division of Reliance Life Sciences Private Limited, Navi Mumbai)
Designation : Executive- Clinical Research
Job Responsibilities :
- Performs site Initiation, Monitoring and Close-out activities
- Telephonic monitoring and records of the same
- Communicates with the sites on administrative matters such as Ethics Committee communication and site agreements/ payments
- Reports patient status at site to sponsor/ Project Manager
- Reviews patient related logs, forms and reports in-house
- Tracks protocol deviations, adverse events and study material at sites
- Assists sites in adverse event reporting and recruitment strategies
- Maintains documents related to the sites in-house
- Performs administrative duties including attendance at clinical monitoring staff meetings, project team meetings and clinical training sessions
- Identifies and records quality problems
- Suggests, initiates, recommends and/or provides solutions as appropriate
- Performs other study related tasks as assigned by Project managers.
- Coordination for study start-up activities and regulatory process
- Liaison with legal, finance, administration department of Reliance for study related activities
- Liaison between sponsors and investigators.
- Maintenance of Clinical Operation Binder and trial related files.
- Clinical Research Experience :
Indication of the study / Disease Study Type and Phase Role in the Study
Locally Recurrent or Metastatic Breast Cancer A Double-Blind, Randomized Phase IIb Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo when Administered in Combination with Paclitaxel in Patients with Locally Recurrent or Metastatic Breast Cancer, -USFDA registration study.
- CRA
Renal Cell Carcinoma A Phase II, Placebo-Controlled, Randomized, Discontinuation Trial of AV-951 in Patients With Renal Cell Carcinoma, - USFDA registration study. - CRA
NSCLC A Randomized Phase II Trial to Evaluate the Safety and Efficacy of RC-1291 in Patients Receiving Chemotherapy for NSCLC - USFDA registration study.
- CRA
PCI and Peri-Operative Reperfusion Treatment A Prospective, Randomized (3 :1), Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase IIa Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1) -USFDA registration study. - CRA
Indication of study / Disease Study type and phase Role(s) in study
Unresectable Hepatocellular Carcinoma A Phase III Randomized Study to Evaluate Survival of Patients Treated with Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LED) as Compared to the Standard of Care Therapies in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) - USFDA registration study.
- Co-Monitor with Independent CRA
Renal Cell Carcinoma A Phase II, Placebo-Controlled, Randomized, Discontinuation Trial of AV-951 in Patients With Renal Cell Carcinoma, - USFDA registration study - Co-Monitor with Independent CRA
Type II Diabetes
Multi center, Double Blind, Placebo- Controlled, Dose finding study of AGI-1067 as a novel anti diabetic agent (Phase III), - USFDA registration study - On site training visit with the Project Manager
Type II Diabetes
Multi center, Double Blind, Placebo- Controlled, Dose finding study of AGI-1067 as a novel anti diabetic agent (Phase III), - USFDA registration study - Co-Monitor with Independent CRA.
Glioblastoma Multiforme A randomized controlled comparative trial evaluate the efficacy and safety of the drug as a radiomodifier (Phase-II), - USFDA registration study. - On site training visit with the Project Manager
Acute Medical Illness Global, multicentric study in Acute Medical Illness – Phase IV study. - Co-Monitor with Independent CRA
Acute exacerbation of chronic bronchitis (AECB)
A Phase III, randomized, multi center, open labeled study of Prulifloxacin versus Augmentin® in patients with acute exacerbation of chronic bronchitis (AECB). - In-house Monitor
Chronic Stable Angina Pectoris An Open Labeled, Randomized, Parallel Group, Multicenter study of Ivabradine as compared to Aten-50® in patients with Chronic Stable Angina Pectoris (A Phase III).
- In-house Monitor
Renal Cell Carcinoma A Phase II, Placebo-Controlled, Randomized, Discontinuation Trial of AV-951 in Patients With Renal Cell Carcinoma, - USFDA registration study.
- In-house Monitor
Locally Recurrent or Metastatic Breast Cancer A Double-Blind, Randomized Phase IIb Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo when Administered in Combination with Paclitaxel in Patients with Locally Recurrent or Metastatic Breast Cancer, - USFDA registration study. - In-house Monitor

Quality Assurance Experience :
- Assisted the Quality Assurance team of Early Development, Reliance Clinical Research Services which was undergoing a FDA inspection and a CAP audit.
Research Experience as part of B.Sc. :
Research on “Carcinoma Cervix” as part of summer training for the partial fulfillment of B.Sc. Degree.
A c a d e m i c Q u a l i f i c a t i o n s :
Qualification College/University Course subjects Percentage/ aggregate
PGDBA
2009-11 Symbiosis Centre for Distance Learning, Pune (Maharashtra) Operation Management Ongoing
M.Sc
2004-06 Devi Ahilya Vishwavidyalaya, Indore ( Madhya Pradesh ) Life Sciences 81.60%
- Training & Workshops attended :
- Workshop on “Study Management” (28 & 29 May 2010) - By Indian Society for Clinical Research (ISCR) at Hotel Mirage, Andheri (E), Mumbai
- “Clinical Trial Project Management & Cultural Skills” workshop (26-27 May 2010) - By the Institute of Clinical Research (ICR) at Glenmark Pharmaceuticals Ltd. (R & D Centre), Navi Mumbai.
- “UK Statutory Instrument” Training (26 Nov 2009) - By j3i Quality Management Services at Glenmark Pharmaceuticals Ltd. (R & D Centre), Navi Mumbai.
- Conference on “Good Monitoring Practices” (31 Jan 2009) – By Reliance Institute of Life Science at Reliance Corporate Park, Navi Mumbai

- At Reliance Clinical Research Services Private Limited
ON JOB
- Training on Medical Terminology
- Therapeutic Area training on NSCLC
- Acute myocardial infarction
- Angina Pectoris
- Training on Emergency medications
- Project Management
- Monitoring Tools & Techniques
- Training on IP Release Checklist
- Training on Electronic Filing
- USFDA audit Findings
- Disaster Recovery & Business continuity Process
- Use of MS office application
- Training on SAP
- E-mail Etiquettes
CLASS ROOM
- Young Clinical Professional Program (May 2007-August 2007)

- Drug discovery and overview of drug development
- New drug Vs generic drug development
- Clinical trial life cycle
1. ICH-GCP
2. Clinical trial regulations
3. Phase I- IV clinical trials
4. Pharmacovigilance & medical writing
5. BA/BE
Skill Sets
- Service oriented approach, flexible and proactive towards changing clients' needs
- Excellent verbal and written communication skills
- Ability to work unsupervised taking responsibility for own actions
- Systematically perform activities in a timely and accurate manner
- Work precisely according to procedures, rules and regulations
- Flexible and open to change
- Working knowledge in SAP & MS office
- LAN Structure
Thanks with best regards,

Rina Kumari
+91 9987003175

[Guest]

Objective :
To secure a position whereby hard work, dedication and ability to acquire new skills will advantage any company I work for.
Current employer details
Company : - Manipal Centre For clinical research (Manipal University)
Address : - 7th floor, KMC Hospital, Attavar, Mangalore - 575001
Designation :-Clinical Research coordinator
Month/years of experience : - one year
Work experience
Department No : of trials Phase
Gastroenterology 1 3b/4
General Medicine 1 3
Oncology 1 3
Psychiatry 1 3
Previous employer details
Company : - Health and Research Centre
Address : - 1st Floor, Devi scans building, Kumarapuram, Medical College, Trivandrum
Designation :-Clinical Research coordinator
Month/years of experience : - 3 months
Work experience
Department No : of trials Phase
General medicine 2 3
Cardiology 1 3
Professional qualification :
- Completed 6 months Clinical Research Training from Altree lab, Cochin.
- Completed Post graduate Diploma in Clinical research from Annamalai University (Distance Education), Chidambaram.
- Completed Fellowship in Clinical research from Apollo Hospital, Hyderabad (online program).
Educational Qualification :
Degree/
course Discipline School/College Board/
University Year of
Passing
Fellowship in clinical research Clinical Research Apollo Hospital Medvarsity online limited 2010
PG Diploma in clinical research Clinical Research Annamalai University Annamalai University 2010
M.Sc. Microbiology Karpagam arts and science college, Coimbatore Bharathiar University 2009
B.Sc. Microbiology St.Mary’s college for women,Thiruvalla Mahatma Gandhi University 2007
H.S.C - Raja kesavadas N.S.S Higher secondary school,Trivandrum Board of higher secondary examination 2004
10th - Sree Vidyadhi Raja Vidya Mandir, Thiruvananthapuram. SSLC 2002
Responsibilities as a study coordinator
- Coordinating with PI in subject screening, Randomization, drug dispensing, IVRS/IWRS, drug accountability
- Subjects follow ups
- Source Documentation
- e CRF filling and query resolution
- Coordinating with CRA during site selection, monitoring visits and close out visits
- AE and SAE management
- Maintenance of Trial Master file(TMF)
- Ensure ethics committee receives safety notifications and other study related information as per regulatory requirements.
Workshops and Seminars attended
- State level conference and certification Program on Pharmacovigilance
IT Skills :
- EDC Software : Oracle, Inform, Medidata Rave, Data Track, Data labs
Papers presented
- Cellular effects of arsenic trioxide in cervical cancer.
Academic Projects
- Isolation & genetic variation in antibiotic producing in microorganisms.

[Guest]

Sruman Bandaru
sruman.bandaru AT gmail.com



Career objective :
To work in a creative and challenging environment using cutting edge technologies where I could constantly learn and successfully deliver solutions to problems, which provide an environment to improve my technical and analytical abilities in Clinical Research
Academic Profile :
· Bachelors in pharmacy from Rajiv Gandhi University of health sciences, Bangalore in the year 2007
· M.B.A in clinical pharmacology and intellectual property rights
· Registered Pharmacist under Karnataka State Pharmacy Council.
· Underwent training in ICH GCP conducted by SIRO Clin Pharm Pvt.Ltd
Industrial work :
Undergone industrial training from Pelcoat formulations, Hyderabad as a part of my course curriculum.
TECHNICAL SKILLS :-
SAS Tools :
SASV9, SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/MACROS,
SAS/GRAPH, SAS/STAT, SAS/ODS
Experience : 1
· Currently working with Apotex Research Pvt Ltd (India) with Clinical Operations Department as Clinical Research Associate from 20th July 2009 to till date.
Job description :
Ø CRA
· Monitored clinical trials via site evaluation, initiation,interimand close-out visits; performed review/data collection and ensuredcompliance with multiple protocols, FDA regulations and ICH/GCPguidelines for Phase II, III, and IV trials; completed various dutiessuch as file audits, regulatory documents review; collection of querysubmission/resolutions, data review, and protocol training.
· Conducted audit for all internal files for three large Phase
IIIulcerative colitis studies.
· Documented audit findings and circulated information to theclinicalteam.
· Reviewed all monitoring reports to verify that all action itemswerefollowed up to resolution. Documented and tracked all outstandingaction items.
· Reviewed monitoring reports to track and document all protocol
deviations.
Clinical SAS Experience :
· Even I got opportunity to Sucessfully exicute Randomizaton Schemes for five bioequivalence studies using SAS PROC PLAN which include Two way cross over and Three way cross over.
· Capable of exicuting Randomization Schemes for Phase Trials.
Experience : 2
· Worked with Synapse Clinical Research Organization as Clinical Research Associate with Clinical operations department from May 2nd 2008 to July 2nd 2009.
Job description :
· Regional monitoring of clinical studies while assuringadherence toGood Clinical Practices (GCP) and International Conference ofHarmonization (ICH) guidelines, while in compliance with studyprocedures.
· Conducted various site visits including site validation, studyinitiation, interim, site audit and closeout visits to theinvestigator sites verifying all data was consistent and accurateagainst all source documents.
· Tracked patient enrollment, reconciled queries and completedstatusupdate reports on projects.
· Therapeutic experience includes : CNS monitoring phase II and IIIstudies.
· Completed monitoring guidelines, Lead CRA training, attended
Investigator meetings and mentored new employees.
· Performed the following training : interim and closeout visits,
timemanagement, and regulatory document review.
· Utilized electronic CRFs for a phase II study.
Experience :3
· Worked with Wipro Business process outsourcing for 5 months from December 6th 2007 to May 1st 2008
Job description :
· To handle incoming calls of customers and resolve queries about their capital one credit card accounts.
Other activities :
Represented our college at 2nd national pharmacy students convention for the poster presentation on the topic “PHARMACISTS FOR BETTER QUALITY OF LIFE”
Paper Presentation at International biopharmaceutical association (IBPA) :
Advances in chemotherapy for leukemia-A review, published on July 2007
Paper presentation at International biopharmaceutical association (IBPA) :
Oncological clinical trials-A review, published on October 2005

[Guest]

RESUME

SHIVARAMARADHYA.G.N
Email ID : shivaram.aradhya AT gmail.com
-----------------------------------------------------------------------------------------------
Career Objectives :
- To sharpen by learning skill and yield good productivity in the various tasks that I take up.
- Seek a challenging career in Diagnostics where I can utilize my conceptual, technical skills efficiently for organizational growth and for self-satisfaction.
Skill sets : Laboratory techniques
- Staining techniques.
- Rapid plat form Test.
- Culture techniques.
- Phlebotomy.
- Operating fully automated automated analyzers
Key Strengths
: Hard working nature.
: Enthusiasm to work in a competitive environment,
: Always trying to improve my skills and knowledge
: Following experienced people to learn more things
Educational Qualification
- SSLC from board of secondary education,karnataka
- Diploma in medical laboratory Technology-Vocational education board, Karnataka
- (BSc Medical Laboratory Technology)
Additional Training
- Revised National tuberculosis control program – Govt of Karnataka,
- Care, Breeding & Management of Laboratory Animals – CARF NIMHANS,
Work Experience :
Name of the organization From To Post Held
Gurushree Hospital
05-01-1995 28-09-1999 Lab Technologist
Mathru Nursing Home 10-07-1999 15-03-2001 Lab Technologist
Samarth Laboratory 20-03-2001 10-03-2004 Lab Technologist
Raja Rajeshwari Medical college & Hospital 15-04-2004 13-08-2007 Lab Technologist
Shivamoga Institute of Medical sciences & Hospital 21-08-2007 05-06-2009 Lab Technologist
Padmashree Diagnostics ISO 15189 NABL Accredited Lab 15-07-2009 25-06-2010 Lab Technologist
M S Ramaiah Hospital & Medical College 01-07-2010 29-08-2011 Lab Technologist
J Mitra & Co,Pvt,Ltd 02-09-2011 Till Today Technical executive

Date :
Place : Bangalore (SHIVARAMARADHYA.G.N)