www.c3i-inc.com C3I Support Services Pvt Ltd Hyderabad : Staff Nurse

[mskavi]

C3I Support Services Private Ltd Hyderabad / Secunderabad : Staff/Research Nurse - Night Shift

Designation: Staff/Research Nurse - Night Shift

Job Description:
We are looking forward to Hire Staff/Research Nurse to work with us in our Clinical Operations Team.
MUST BE OPEN TO WORK IN SHIFTS
LOCATION HYDERABAD

Desired Candidate Profile:
Must have EXCELLENT communication skills.
• Extensive knowledge in ICH-GCP
• Applicable regulatory guidelines (schedule Y,US-FDA)
• Other guidelines(ICMR&INDIAN GCP)
• Pediatric care
• Medical care
• Surgical care
• Psychiatric care
• Care in obstetrics
• Pharmacology
• Therapeutics
MUST BE REGISTERED NURSE

Address:
C3I Support Services Private Ltd
B4,Vanenberg IT Park Plot#17,Software Units
Layout Madhapur
HYDERABAD,Andhra Pradesh,India 500081

Email Address: mkataria@c3i-inc.com
Website: http://www.c3i-inc.com

[Guest-IJT]

respected sir/madam,

I am Tejal Kakadia , have been completed my post gradualtion in clincial research, microbiology and PGDC in clincial reserach management. i have 1 year working experience as a quality assurance auditor in very reputed CRO. I am a well trained with monitoring process, ICH-GCP guildlines, GLP and faced variouse regulatory audit in prespective view of handling accurate data and compeltion of CRFs. by coming to my possitive points, I am a selfmotivated and have capablity to except the challenges in very professional ways. If given me chance as a clinical reserach associator, I can give my the best effort which makes your organisation in leading position. i have enclosed my CV with below so kindly see that.


Hope your positive response.

tejalkakadia AT gmail.com

AIM:
To be a part of an organization that allows me to grow as an individual and obtain a senior role within the organization in a creative and challenging environment. To secure a rewarding assignment to lead a team through skilful management and by motivating, training and supporting the team to achieve higher standards of performance, while maintaining a positive learning curve.

EXPERIENCE:
- Research Officer Trainee: At Accutest Research laboratories Pvt LTD, Ahmedabad since March 2009 till date.
o Quality Assurance auditor– IP and retrospectrive audit, BA/BE studies and clinical trial phase III, auditing and monitoring process.

- Assistant Trainee Researcher: At Prudent Clinical Research since February to March 2009 till date
o Therapeutic Area – Acute Decompensated Heart Failure, Phase III, Feasibility and monitoring process.

- Research Trainee: At Zydus cadila “at Ahmedabad (Gujarat, INDIA) since 1st January to 29th April, 2005.
o Therapeutic Area – microbiological tests on pharmaceutical products guided by Dr. Rajesh Guar (Head, department of microbiology).

- Microbiologist trainee: As a trainee in Bio fertilizer department and central laboratory of “Krishak Bharti Co-operative Ltd (KRIBHCO)” at Surat (Gujarat, INDIA) from May 2004 to June 2004.

TECHNICAL EXPOSURE:
- Successful faced two regulatory audit on clinical data accuracy part at accutest research laboratories PVT LTD.
- Well trained on ICH-GCP, GLP by accutest research laboratories PVT LTD.
- Under trained to faced sponsor’s audit as a quality assurance auditor.

WORKING EXPERIENCE:

ACCUTEST RESEARCH LABORATORIES PVT LTD, Ahmedabad.

1.Quality Assurance Auditor from Date: (March 2009 till date)

As a Research Officer Trainee in Quality Assurance department, I have a responsibility of handling all aspects of in-process audit(IP Acceptance, dispensing process, Dosing, blood collection, separation and storage process, sample segregation, IP retention or removal), Retrospective audit (ICF and protocol audit, in process label checking , clinical report summary, CRF audit, TMF audit, sample transfer record audit ), clinical final report auditing including audit plans conduction at timely manner and reporting audit findings and its resolution processes. Also reporting the day-to-day trial scheduled progress to the QA Head, taking care not to miss out any of the Standard Operation procedures and the protocol guidelines. The care was taken to assuring the quality of the data generated by following the protocol, ICH GCP guidelines and Regulatory Requirement guidelines. Ensure the proper collection, verification, and reporting of qualitative data and audited clinical Final report. Capability to handle the healthy relationship with user departments in professional way and successfully completion of projects more efficient and timely manner.

Job Responsibilities:
- In-process auditing (IP Acceptance, dispensing process, Dosing, blood collection, separation and storage process, sample segregation, IP retention, disposal or removal)
- Retrospective audit
- Statistical Time point deviation audit
- Development of audit plans; conduct audits as per audit plan with provided timely manner and report audit findings.
- Review and verification of the raw data like ICF, randomization schedule and code, protocol, CRF, clinical final report audit and TMF.
- Direct communicate with user department to resolution of findings or queries by taking proper action against non compliance to improve the work flow of system.
- Providing surety of the guidelines, protocol and SOPs compliance during the study.
- Label checking and sample transfer record audit

Additional Responsibilities:

- Took several training sessions for monitoring and audit.
- Member of the auditor group within the company.
- Took GCP,GLP, Bio-west handling and safety training.
- Well trained with respect to many sponsor audit and regulatory audit of different countries.


PRUDENT CLINICAL RESEARCH
2.Associate Research Trainee, Date: (February to March 2009 )

As Associate Research Trainee, I have a responsibility of assisting my seniors in feasibility and monitoring Clinical trial proceedings, including PI identification, site initiation, maintenance and management of trial site activities. Also maintaining healthy professional relationship with the third party vendors, PI, CRC and also with in the peer group. The ability to maintain good relationships with the people has always helped me get my work done quickly and more efficiently on time.

Job Responsibilities:

- Designing of general feasibility questionnaires
- Identification of sites to conduct clinical trials
- Obtaining feedback from the qualified sites and remaining in constant follow up of qualified sites.

Additional Responsibilities:

- Took several training sessions for monitoring and documentation.
- Assistant research trainee of Global feasibility group within the company.

FEASIBILITY: Assisting the senior feasibility specialist to identify potential PI and trial site for conducting clinical trial by following the standard SOPs and protocol. Then generate the reports and document the same in order to provide the feedback to the Global Feasibility coordinator. Design the feasibility questionnaire and follow-up with the identified sites to obtain the completed feasibility questionnaire feedback .

Zydus Cadila Health Care Pvt, LTD, Ahmedabad

3. Research Trainee - Date: (January 2005 to April 2005)

As a research trainee I have been performed a dissertation program on microbiological tests on pharmaceutical products guided by Dr. Rajesh Guar (Head, department of microbiology). I have been well experience regarding microbial analysis process and the documentation of all the data reports and taking care not to miss out any of the Standard Operation procedures. The care was taken to handling all the microbiological test process done on pharmaceutical products and qualitative results generated to accept or reject the lot or batch number of pharma products. Ensure the proper sterility testing, environmental monitoring, water analysis tests were performed in microbiology laboratory.


Job Responsibilities:
- Identification of microbial endotoxins in pharma product by performing the LAL test.
- Performing the Microbial Limit Test for different pharma products like capsules, tablets, syrup etc.
- Assuring the sterility process of drugs to identify amount of microbs present in the injectable preparations and inhalers.
- Identification of any new microorganisms present on pharma products, water and environment and its role for pathogenisity..
- Performed the water analysis test for raw water, injectable water, highly purified and purified water.
- Check the environmental monitoring regularly at pharmaceutical product manufacturing areas.

Was appreciated by the senior microbiologist and Head of the department:

- For being proactive and taking the ownership of the work assigned.
- For the ability to perform multi-tasks and work independently.
- Strong sense of urgency.


KRISHAK BHARTI CO0OPERATIVE LTD( KRIBHCO)
4. Research trainee - Date: (May 2004 & June 2004)

The primary responsibility was to research on the H2s gas generation project by Psuedomonas aerogenosa from the underwater plant of the bio fertilizer plant of Kribhco. The microbiological background and identification of microorganism’s skills has helped me to exceed my targets.

I have been appreciated for my microbiologist skills coupled with the lab technicians skills and commitment to reach the targets.

Additional Responsibilities: Microbiological analysis of soil and water, in order to provide valuable and more effective product to enhance bio-fertilizer brands. Involved in collection of data for microorganisms contaminates the bio-fertilizer fermentation plants and the water used for the injection in the fertilizers.

ACADEMIC ACHIEVEMENTS:

1. M.Sc. in Clinical Research from Cranfield University - UK, with 60 % through 2007-2009.
2. Post Graduate Diploma in Clinical Research Management from Institute of Clinical Research (India), Ahmedabad, with 62.2% through 2007-2008.
3. M.Sc. in Microbiology from Sardar Patel University – Vallabh Vidhyanagar, with 56 % through 2004-2005.
4. Bachelor in Microbiology from Sardar Patel University – Vallabh Vidhyanagar with 53% through 2002-2003.
5. H.S.C. in Science from Gujarat Higher Secondary Education Board (GSEB), Gandhinagar, with 52.15 % through 1999-2000.
6. S.S.C from Gujarat Higher Secondary Education Board (GSEB), Gandhinagar, with 79% through 1997-1998.

Summary of Skills
- Quality assurance auditor and auditing trial related all activities.
- In process & raw data auditing and queries resolutions.
- Clinical monitoring.
- Site Feasibility & Site Identification.

Leadership Expertise

- Project Coordinator in quality assurance Dept. in acutest research laboratories PVT Ltd, managing all audit related process.

Awards Obtained
- Got 1st prize in poster making competition on National Science Day celebration held in 2003 (DBT Sponsored) at Department of Bioscience, S. P. University, Vallabh Vidyanagar ( Gujarat , INDIA ).

- Awarded first winner by ICRI, Mumbai for add-mad competition representing on clinical research work as a part of cultural program.


- An overall well performed QA auditor in acutest research laboratories Pvt Ltd, for active participation at working responsibilities, quality of work, dedication towards target and effective presentation skill.

WORKSHOPS/ CREDENTIALS

- Attended seminar on Regulatory Affairs in the field of Clinical Research held by K.B. Institute of Pharmacy at Gandhinagar.
- Submitted project work on various topics like Interleukin-1ß antagonist in type-II to diabetes mellitus, Grant proposal for newer asthma device, HRT in breast cancer, protocol designing and ICH- GCP guidelines as law to Cranfield University - UK.
- EU guidelines for the successfully completion of trials at acutest research laboratories, Ahmedabad.
- Effective audit management and resolutions of queries at acutest research laboratories.
- Successfully completed online four workshop program on US-FDA regulatory affairs organized by Cranfield University – UK at ICRI –Ahmedabad.
- Attended a survey to assess “the Informed Consent Process in developing countries “at ICRI, Mumbai in April, 2008.
- Microbiological formation of environmental pollutant conducted at the department of Biosciences at V.V.Nagar.
- “Mycorrhizae “and “Yoghurt “conducted at the department of Department of dairy technology at Anand.
- “Regulatory approval process for clinical trials in different countries” at ICRI, Ahmedabad.
- Submitted thesis work in clinical research management course on OUTSOURCING IN CLINICAL RESEARCH to ICRI – Ahmedabad .
- Worked for thesis submission at cranfield university at UK on “A Methodological analysis to ascertain better Project Management with a view to improve First Patient-In (FPI) to Last Patient Out (LPO) timelines in India when compared with other countries.”

OTHER DETAILS:

Languages Proficient:
- English (Read, write & speak)
- Hindi (Read, write & speak)
- Gujarati (Read, write & speak)

Hobbies:

- Meeting people
- Swimming
- Travelling
- Web searching

Marital Status:
- Single

STRENGHTS
- Willing to take challenging jobs
- Effective organizational and time management skill
- Job satisfaction is a major priority
- Sense of responsibility
- Work as team player and Highly inquisitive
- Excellent communication skill and positive attitude

COMPUTER SKILLS

Excellent hands on MS word, Excel and PowerPoint.

AREAS OF INTEREST
- PROJECT CO-ORDINATOR OR QUALITY ASSURANCE OFFICER
- CLINICAL RESEARCH ASSOCIATE OR TRAINING & MANAGEMENT OF PROJECTS

Declaration:

I Tejal D.Kakadiya hereby declare that the above-furnished information is correct and to the best of my knowledge.

Place: Ahmedabad
Date: 07th September, 2009
Tejal D.Kakadiya

[Guest]

JUVERIYA FATIMA

Email :missmsc2010 AT gmail.com,missmsc2010 AT live.in.
CAREER OBJECTIVE
A hard-working and dependable B.sc (MCC)graduate and post graduate in M.sc (micro biology) with the ability to work well both independently and in a team. To pursue a challenging career and reach new peaks of success. To be a source of strength and dedication .To whom so I may be working with , in the field and leading to organization growth.
STRENGTHS
- Quick grasp and an ardent learner.
- Effective planning, organization and management skills.
- An analytical mind with a problem solving approach.
- Innovative and a firm believer in hard work.
- Effective communication and Interpersonal skills.
- Self – motivation ,Hardworking , Adaptive and capable of motivating other team members , optimistic and independent.
TECHNICAL SKILLS
Windows xp : operating & installation
Operating system : Windows 98/2000/ XP, VISTA, Linux Formatting & troubleshooting
D C A : Microsoft word, excel, power point.
Internet Concept : Browsing.
EDUCATION
BACHELOR IN COMPUTER SCIENCES
Passed in the year 2008 from Osmania University, India.
MASTER OF SCIENCE ( MICROBIOLOGY )
Passed in the year 2010 from Osmania University, India.
ABOUT MYSELF
I am an amicable person, I more often try to cut cost and prefer taking calculated risk. I believe that confidence, positive attitude and optimistic approach towards the problem is the key to success in life. I respect all the religion around the world all of them teaches to serve and benefit humanity.

PERSONAL SKILLS
Very much extrovert in nature. Honest and sincere with the task being placed for the accomplishment of the organizational objectives. Co-operative with the persons around in the organization for attaining group goals.
- Proficient in communication
- Great sense of commitment
- Time to time interaction with the concern authorities for smooth running of the task.
- Good absorption ability in a new working environment