www.nib.gov.in Recruitment 2012 National Institute of Biologicals : Technician
Name of the organisation : National Institute of Biologicals ( nib.gov.in ) Name of the post : Recruitment for Technician in 2012
The National Institute of Biologicals, an autonomous institute under the Ministry of Health & Family Welfare, Government of India, is a scientific regulatory body to ensure high quality & safe diagnostic, preventive and therapeutics biomedicine.
The following position is available for contractual appointment under External Quality Assessment Scheme (EQAS) under NACP of National Aids Control Organization (NACO).
Qualification & Experience : (i) B.Sc. Or DLMT with Two-Three years laboratory experience in Medical microbiology/immunological laboratory techniques. Candidate with DLMT degree and experience in immunological techniques will be preferred.
Job Responsibilities : To undertake technical laboratory work related to panel preparation and EQAS, assistance in maintenance of laboratory equipment implementation of SOPs for all lab. Techniques, implement guideline for Biosafety and Biomedical waste management, assist in timely procurement of laboratory equipment and consumables required for the laboratory, maintenance of laboratory records as per instructions of seniors, assists the laboratory for all laboratory related issues for carrying out the day-to-day work. These duties will be carried out by the candidate under the supervision of Officer/Laboratory in –charge.
Last Date : The last date of receipt of complete applications is 16-01-2012
Last edited by mariammal; January 12th, 2012 at 12:16 PM.
Name : neeta vilas nalawade Email : neeta.nalawade AT yahoo.com Designation / Skillset : clinical data processor/ clinical data coordinator
Hi,
Myself Neeta, I have completed M.Sc in Microbiology & PG diploma course in clinical research & Clinical dat managment course in oracle clinical 4.6 . Please tell me if anybody knows openings at any CDM dept. at pune location.
I have almost 1 years of experience at I3 Statprobe Pune in Clinical data management(CDM).
here is my CV;
Resume :
PORFESSIONAL OBJECTIVE :
Seeking a career in Database Management where I can utilize my extensive computer and medical apparel knowledge, strong organizational abilities, strong organizational abilities, demonstrating quality and communications skills.
1. Clinical Data Processor From Dec-2010 –Till 10 June 2011
I3 Statprobe Pune India Roles & Responsibilities :
- Perform first pass and second pass entry of the data
- Scan and index new data received
- Assist Case Record form management
- Log Case Record Form
- Visually check data listing
- Provide quality control on complete work
- Cross train across all active project
- Assist with other other miscellaneous activity as requested
2.Clinical Data Management Internee 12th OCT 2010 -3rd Jan
PPCE Pvt Ltd Pune.
We have been oriented on Oracle suite of products like Oracle Clinical (Ver. 4.6 HTML), Oracle TMS (Ver.4.6.1) both on theoretical and had on aspects of the study.
PROJECT-I
- Worked on Phase III trial on Ulcerative Colitis Roles & Responsibilities :
- Annotating the CRF
- Study data Base Designing
- Global Library (DVG’s, Question Group
- DCL &DCM creation for Physical Examination (PE), Vital Signs (VS), Inclusion/Exclusion, Lab test, AERS etc.
- Understanding Data Entry Guidelines designed as per the study
- UAT (User Acceptance Test)
- Data Entry (First &Second)Pass
- Discrepancy Management
- Validation & Derivation procedure
- Data Closure and Locking.
Organization :PPCE (P)Ltd. Pune Tools : Oracle clinical (4.6html), Oracle TMS (4.6.1 html)
3. Clinical Research Co-ordinator From Jan-2009 –Dec 2010
Poona Hospital And Research Center-Pune - Clinical Trial Indication :
- GI(Ulcerative Colitis ) Phase III
- Crohn’s Disease Phase III
- Maintenance pahase of above mentioned study phase III Overall Responsibilities :
- Clinical Research Coordinator (Blinded)
- Schedule patient visit and organize for all routine and specific Investigation.
- Reporting and Coordinating of SAEs in specified time lines.
- Maintain During accountability and relevant logs.
- Maintain source documents and completion of CRFs and eCRFs.
- Submit the DRFs timely and answer data queries in time.
- Communicating and coordinating with IRB for all protocol related duties. SUMMARY :
- Knowledge of 21 CRF PARAT 11, Good Clinical Data Management Practice (GCDMP).
- Good in Data Base Designing, Glib, Data Management in Oracle clinical (4.6) in Clinical Domain.
- Knowledge in primary SOC allocation and matching verbatim to preferred terms (PT’s)
- Knowledge on version of dictionaries, dictionary maintenance.
- Good Comprehension of FDA guidelines, Good Clinical Practice (ICH GCP).
- Knowledge of clinical Trial Data like Demographic Data, Adverse Event (AE),Serious Adverse Events (SAE), and Laboratory Data (Lab Data).
- Perform all functions all activities of related to Data Entry like First Pass and Second Pass Data Entry, Review of Data Entry, and Database updates. Well versed in reading hand written patient documents.
- Good Knowledge of Clinical Trial Management System (CTMS) & all phases (Phase-IV) of clinical trial.
- Code Case Report Form (CRF) verbatim terms using standard or client supplied dictionaries to standardize nomenclature.
- Define edit check to be programmed for the study project and reviewing programmed edit checks.
- Good knowledge in understanding SOP, Qualification Protocol.
- Good Knowledge in accessing data from databases like Oracle, MS Excel, Ms Word.
- Experienced in doing pilot projects.
- Good analytical and comprehension skills. POFESSIONAL QUALIFICATION :
- Advanced Certificate Course In Clinical Research during 2009
- Completed Post Graduation in MSc from Pune University during year 2009 SKILLS :
Oracle Clinical (4.6 html) - Data Plan :
Defining programs,
Defining Organization Units,
Defining Regions,
Defining Studies. - Data Design :
Easy Study Design.
Creating Intervals.
Creating Events.
Creating Single Regimen Treatment.
Creating Patient Positions.
Addition Of Investigators.
Addition Of Sites. - GLIB :
Creating DVG’s
Creating Questions.
Creating Question Groups.
Creating DCM’s & DCI’s. - Data Definition :
Copying DCM’s, DCI’s from GLIB. Validation Procedures Eg. :Bach Validation
Test a Study
Test Data Entry
- Data Entry - Discrepancy Management :
- Database Closure (Locking).
PROJRCT SKILL SET : - Database :Oracle Clinical (4.6), Oracle TMS (4.6.1) - Languages : MS-CIT - Operating System :Windows 98/2000/XP professional. - Packages : MS-office.
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More Information about this submission and submitter:-
___________________________________________________
Submission ID : 4392763
Date & Time : 20th Jul 2011 1:42 PM (UTC)
IP Address : 115.240.12.206
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Predicted Country : India