Training Quality Assurance

BHAWAN P. PATEL

**********@*****.***

*** ****** *****, */*, Gita Products,

Near bankers heart institute, Rana Street, Golwad

Old Padra Road, Vadodara-390020, Valsad-396001

Gujarat, India Phone No: +91-937******* Gujarat, India

OBJECTIVE: To seek full time employments in the field of Bioequivalence and Clinical trials studies and hone my skills by working efficiently and effectively with challenging projects.

EDUCATION:

Pune University, Maharashtra, India

Bachelor of Pharmacy with higher secondary class

PROFESSIONAL EXPERIENCE:

From October 2005 to November 2005:

Worked as Trainee Quality Assurance personnel in Sidmak Lab Ind.

JOB PROFILE:-

Batch Size Calculation

Line Clearance

Performing Dissolution test

Friability Tests

Hardness Tests for tablets

From April 2006 to till date:

Clinical Research Associate

(RESEARCH ASSISTANT GRADE II)

Clinical Research Associates, in Clinical Pharmacology Unit, Sun Pharmaceutical Industries Ltd., Tandalja, Vadodara, India

JOB PROFILE:-

Designing of Research Protocol, Patient information sheet and C.R.Fs and/or eCRFs as per different regulatory guidelines.

To manage Investigational study sites and performed on-site quality review of CRFs data and completed Clinical Reports of studies as per regulatory guidelines for USFDA, EMEA, and ANVISA etc.

Conduct study feasibility, identify sites, and conduct site evaluations.

Submitting research proposal to Ethics Committee.

Submitting adverse events and serious adverse events to Ethics Committee and Sponsor and regulatory agencies.

Conducting protocol training before initiation of trials.

Locating and assessing the suitability of facilities at a study center.

Monitoring trials and ensure research protocol compliance as well as Good Clinical Practice.

Setting up the study centers, which includes ensuring that the study center has the trial materials, infrastructure and training site staff to ICH GCP, local regulatory requirement, trial specific procedures and industry standards.

Initiating/activating the sites for conduct of trial.

Monitoring the trial throughout its duration, this will involve visiting the study centers if conduced in multi center.

Verifying that data entered on to the CRFs is consistent

Perform investigational product accountability, dispensing for studies.

Collecting completed CRFs and making clinical reports after completion of the study.

Ensuring all unused trial supplies are accounted for.

Helping the site to resolve the data clarification forms.

Closing down study centers on completion of the trial.

Reporting protocol deviation/ SOP deviations.

Clinical Data Review.

Making of Clinical Report.

Archiving study documentation and correspondence.

Manages, coordinates, attends and participates in investigator and coordinator meetings.

Instrument Handled:

Motara ECG machines

Nebulizer

Glucometer

Infusion Pump

Megafuge Centrifuge Machine

Area of exposure:

Study Title: Pharmacodynamic study of Compound XXX in Subjects with Symptoms of Asthma: A Randomized, Open Label, Crossover study.”

Study Title: A randomized, open label, balanced, crossover study to compare the bioavailability of compound XXX Extended Release Capsules (GRS) adult, human subjects when administered 1) along with High fat High Calorie meal. 2) along with Normal meal & 3) In fasting condition ( Food- Effect Study)

Study Title: A randomized, crossover, relative bioavailability study of Compound XXX given as single dose after high calorie high fat meal (fed conditions) and Compound tablets given three times at 8 hour interval, with the initial dose administered under fasting condition, in healthy human adult subjects.

Study Title: Safety, efficacy and pharmacokinetic study of XXX nano-dispersion injection in patients with metastatic breast cancer : A randomized dose ranging active controlled parallel group and multicentric study.

Study Title: Study to assess the dose proportionality of Compound XXX ER Capsules (GRS) 15mg, 30mg and 60 mg in healthy human adult subjects when administered under fed conditions.

Study Title: Absolute bioavailability and pharmacokinetic study following intravenous administration of compound XXX injection and oral administration of xx mg tablets in healthy human adult subjects, under fasting conditions.

Study Title: Mass balance study in urine and faeces and for the Pharmacokinetics of Compound XXX and its metabolites in plasma in healthy human adult male and female subjects under fasting conditions.

Study Title: Dose duration response study of XXX Emollient cream 0.1% in healthy human subjects.

ADDITIONAL INFORMATIONS:

HIGHLIGHTS:

Experienced in Pharmaceutical bioequivalence and Clinical trials research Phase I.

Trained in ICH-GCP, IRB/IEC, and FDA rules and regulations.

Knowledge of Drug Research and Development Process.

Received training of MCC, MHRA, TCA, TPD, EMEA, and USFDA, ANVISA guidelines by internal talks and by seminars.

Good communication and interpersonal skills. Self -starter and strong believer of hard work.

Skills to work well both independently and as part of a team to develop and maintain harmonious environment.

Performed Phase I studies like QT QTc, Steady State, Time Effect Studies, Food Effect Studies, Nasal Spray Studies, Pharmaco dynamic Studies.

Performed more than 100 pivotal studies for different regulatory submissions.

TRAINING:

Handling Bio-study samples organized by World Courier, India.

Received extensive training in ICH-GCP principles from Arcus clinical trial support solution

[Training conducted by: DR. ANUPAMA RAMKUMAR (M.D.)]

Clinical Site Monitoring training for site selection, initiation, monitoring, and closeouts.

Adverse Event Reporting training and Pharmacology for Clinical Research Professionals.

Training for dispensing, handling and maintaining accountability of Investigational Drug Products.

Training for the preparation of Case Report Form (CRF) and raw data recording in CRF.

Training of different dosage forms such as nasal, rectal, local application, sub lingual, intravenous for bioequivalence studies.

Procedure for obtaining informed consent form for volunteers participating in phase I and bioequivalence studies.

COMPUTER OPERATING SYSTEMS:

Microsoft Office: Word, Excel, Power Point.

Windows 98/2k/XP/Vista.

Power Point

LANGUAGE SKILLS:

Speak, Read, Write and Understand English, Hindi and Gujarati.

Educational Qualification:

Examination University/Board Year Of Passing % Of Marks

B.Pharm Pune University, India 2005 56%

Major Subjects studied:

1. Pharmaceutics:

• Pharmaceutical Dosage Forms (Tablet, Capsule, solution, suspension, emulsion, elixir)

• Drug Delivery System

2. Pharmaceutical Chemistry

• Nomenclature, synthetic chemistry, structure activity relationship

3. Pharmaceutical Analysis

• Principles of HPLC, LCMS, MS, IR, Different Chromatographic Techniques

4. Pharmacology

• Mode of actions, Pharmacokinetic, Phamcodynmics, metabolism, Exceation.

5. Pharmacognosy

6. Microbiology

7. Biotechnology

8. Anatomy Physiology

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