www.nimhans.kar.nic.in Recruitment 2012 National Institute of Mental Health & Neuro Sciences : Clinical Research Associate

[muthukalee]

Name of the organisation : National Institute of Mental Health & Neuro Sciences ( nimhans.kar.nic.in )
Name of the post : Recruitment for Clinical Research Associate in 2012

NATIONAL INSTITUTE OF MENTAL HEALTH & NEURO SCIENCES,
(DEEMED UNIVERSITY) , BANGALORE

Applications are invited from eligible candidates for filling up the post of “Clinical Research Associate” on adhoc basis for the Drug Trial project entitled “Efficacy and Safety of AP 12009 in adult patient with recurrent or refractory anaplastic astrocytoma (WHO Grade III) As compared to standard treatment with Temozolomide or BCNU: A Randomized, actively controlled, open label clinical phase III study, (SAPPHIRE)’ – under Dr.S.Sampath, Prof. of Neurosurgery & Principal Investigator

Name of the post : Clinical Research Associate

No. of post : One

http://www.nimhans.kar.nic.in/notifications.htm

Education Qualification :
a) M.Phil or M.S.W
b) M.B.B.S or
c) M.Ch Neurosurgery

Maximum age limit : 40 Years

Emoluments :
a) Rs.18,000/- p.m.
b) Rs.25,000/- p.m.
c) Rs.50,000/- p.m.

Duration of the Post : 3 Years
Initial appointment will be made for a period of 6 months which will be renewed thereafter depending up on the performance of the candidate.

Eligible candidates fulfilling the criteria, may apply on a plain paper with curriculum vitae and copy of the testimonials either addressed to
The Director,
NIMHANS,
P.B.No.2900, D.R.College Post,
Bangalore – 560 029
either post or email to sampath@nimhans.kar.nic.in Candidates who apply, should invariably mention the Notification No. & date without fail, otherwise the applications will not be considered. Late applications will not be accepted.

The last date for receipt of filled in applications together with the relevant documents is 09.01.2012 upto 4.00 p.m. Late applications will not be entertained.

[Guest-IJT]

Name : Shruti
Email : shrutishedge23 AT gmail.com
Designation / Skillset : Clinical Research Associate

Resume :
Career Objective :
To achieve a challenging and creative position by using my interpersonal skills, analytical thinking, hard work and determination & to contribute in the growth of the organization.
Clinical research knowledge :
- Clinical Research fundamentals.
- ICH GCP, Indian GCP, ICMR Guidelines.
- Drug and Cosmetic act-Schedule Y, USFDA, European Union rules and regulations.
- Principles of Pharmacology & Drug Discovery & Development.
- Roles & Responsibilities of Key Stakeholder.
- Protocol development, Preparations & Planning for Clinical Trials..
- Essential Documentation filling & maintenance in Clinical Research & Regulatory Submissions.
- Clinical Trials Project Planning & Management.
- Monitoring essentials and checklists.
- Informed Consent process, enrollment, Case reports, Study reports, Source documents.
- Study Start up Process.
- Feasibility studies, Pre site visit, routine monitoring, adverse event reporting and Study close out.
- Drug & biological sample accountability, Coordination in investigational site
- Clinical Monitoring Essentials Compliance.
- IEC / IRB submission or notification procedure for approval of Study Procedure, Documents, Safety Reports / updates etc.
Professional Qualification :
Academic Credentials University
PGDCTM (Post Graduate Diploma in Clinical Trial Management)-student Cliniminds, Pune
B Sc (Pure science-Chemistry) Fergusson college,
Pune University,
Maharashtra.
HSC SMJC,Talegaon Dabhade,Pune, Maharashtra.

SSC R. P. Vidyaniketan
Talegaon Dabhade, Pune, Maharashtra.
Practical Hands-on :
- Presentation on case report form
- Presentation on Investigator Responsibility
- Presentation on Clinical Trial in European union & United States
- Presentation on 21 Part CFR part 11
- Protocol designed for Phase 1 Clinical Trial of the Vaccination for the patients with Metastatic Melonoma using gp 100-derived epitope peptide restricted to HLA-a*2402
- Informed Consent Document designed for the same study.
- Case Report Forms Designed for the same study.
Soft Skills :
- MS Word, Excel, Power point. Tally
- Internet.
Strength :
- Self analytical understanding.
- Positive attitude in adverse situations.
- High degree of self thrust and motivation.
- Confident, strong will and easily adaptable to any environment
- Innovative thinking.
Expereience :
Completed 4 months internship (from 1st july 2011 to 31st july 2011)in Poona Diabetes Centre.

Declaration :
I hereby declare that the information given above is genuine to the best of my knowledge & if you give an opportunity to work in your organization, I will put my best efforts.
Place :
Date : (Ms Shruti Damodar Shedge)
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4437638
Date & Time : 2nd Aug 2011 5:38 PM (UTC)
IP Address : 121.245.128.201
Browser Info : Mozilla/5.0 (Windows NT 5.1; rv:2.0.1) Gecko/20100101 Firefox/4.0.1
Predicted Country ;: India

[Guest]

Resume
Miss Ann Maria Thachil
E-mail; annmariathachil AT hotmail.com
Objective;
To hold a challenging position that offers career enhancement opportunities and encourages personal dedication and self development.
Strength and professional competency;
- Good communication and interpersonal skills
- Able to maintain positive attitude towards the responsibilities with an aim to deliver the best health care
- Able to work under pressure
- Ability to anticipate needs and situations
- Able to respond well to the needs and preference and paying attention to detail.
- Thorough professional knowledge (medicines & diseases, ICH-GCP, EUdirective, US-FDA, ICMR, schedule -Y, indian-GCPetc…)
- Compassionate and ready to travel 65% of my working time because I believe that in clinical trial traveling is also an integral part.
- Thorough sincerity and honesty, I am confident and determined to do my best in any task at hand
Designation;
- Working as a Director of Clinical Operations in Exodus Research Acer.
- Worked as a team leader in Altree lab Cochin.
- Worked as a Clinical research Executive in clinfound.
- Worked as a clinical research Associate in Altree lab.
Working experience;
- Clinical research associate in Altree lab

Tenure; 2008 July 10th to 2009 February 20th
Area of responsibilities; diabetic, respiratory distress (phase 3)
- Clinical research Executive in clinfound
Tenure; 2009 February 25th to 2009 June 30th
Area of responsibilities; rheumatoid arthritis (phase 3)
- Team leader in Altree lab Cochin.

Tenure; 2009 July 10th to 2010 March 10th
Area of responsibilities; oncology (phase 1), ophthalmology (phase 2)
- Director of Clinical Operations in Exodus Research Acer.
Tenure; From 2010 may12th onwards
Area of responsibilities; specific population study (AIDs) (phase 1), cardiology (phase3), low back ache (phase 1), Arthritic conditions OA & RA (phase 1), H-pylori, Asthma, DM, pre DM, type 2 DM, Ulcerative colitis, Depression, Alzheimer’s, Psoriasis, Allergic response (PROOF OF CONCEPT STUDIES)
Duties and Responsibilities
- Writing and developing trial protocols.
- Presenting protocols to a guiding committee.
- Preparing study detailed documents and study booklets
- Mediating with consultants, doctors or investigators on leading the trial.
- Setting up the study centers and training the site faculty to industry standards.
- Collecting completed Case Record Forms (CRFs) from hospitals and general recitations.
- Supervising the trial’s end-to-end duration.
- Filing and comparing the trial documentation and studies.
- Discoursing results with a medical actuary who writes technical trial studies.
- Preparing terminal reports and at times manuscripts for publication.
- Coordinate the monitoring of the trial and has to make sure that functioning is smooth by properly managing the staff
- Establish audit procedures and ensure that data for the trial is being entered properly and accurately.
- Participate in meetings of corporate research teams and ensure that his colleagues are aware of relevant issues
- To assume full responsibility for financially managing the clinical trial programme including resource allocation, preparation of reports and budget planning.
Academic Qualifications;
COURSE BOARD/UNIVERSITY YEAR OF PASSING
Certified clinical research professional Altree lab, cochin, Kerala 2008
Basic BSC Nsg Rajiv Gandhi university of health sciences 2003-2007
Higher secondary education Board of higher secondary examination, Kerala, India 2001-2003
Secondary school leaving certificate Board of public examination,kerala 2001