Clinical Research Professional Resumes in India-Maharashtra-Mumbai City: Dr. Milind

Clinical Research Professional Resume

Contact Candidate

Name:

Dr. Milind

Location:

India-Maharashtra-Mumbai City

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Clinical Research Professional

Personal Website:

Objective:

To seek a position in Clinical Resaerch Field

Resume Text:

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inical research:
Phase II
• Co-Monitoring for 3 sites done for an Oncology trial
During the co monitoring main task was to find out the mistakes which were ignored in prior monitoring visits by the other monitors. The findings were like
o No signature of subject on ICF
o FDA 1572 was incomplete
o Protocol violations
o Protocol deviations
o Screening, Accountability logs were incomplete
o Site was ignorant about ‘Lab Monitoring Sheet’
o ISF was incomplete e.g. not holding C.V.’s of Lab personnel
o AE pages in CRF were incomplete
o Data not captured on CRF
o Concomitant medication page not filled in CRF though data was present in source
o IP accountability was not up to date

Post Marketing Surveillance:
• Four site initiations done
• During monitoring visit
o Investigative site compliance checked & trained the site on ICH-GCP
o Full source document review done for less data discrepancies
o Investigational supply review done, drug accountability checked
o Trained the investigator & his team on informed consent procedure
• 20 monitoring visits done for two phase IV trials

Data Management:
• Preparing protocol for Phase IV trials.
• Preparing CRF for Phase IV trials.
• Customized ISF, CRF, AE track sheets
• Preparation of ‘Clinical Monitoring Plan’

April 07 to October 07 Clinical Research Coordinator
Dr.B.A. Memorial Railway Hospital, Mumbai
Achievements-
• Screened and enrolled the required number of patients in the trial well within time limit.
• Prepared customized source document template for the trial to capture maximum data present on the CRF in the source files of patient
• Ensured correct and accurate data in the CRF and consequently less data query generation. Faxed the solved data queries within 24 hrs.
• Maintained up to date documentation screening logs, source documentation, correspondence with EC to ensure correct filing of documents
• Updated EC about the various aspects of the trial time to time and got EC approval of various documents like DGFT approval within 4 working days.
• Ensured 24 hr reporting of any AE/SAE occurring at the site.

January 06 to March 07 Consulting Homoeopath & Counsellor
Dombivli
Achievements-
• Conducted camp for 10th std. students for stress management
• Conducted camp for increase awareness for Homoeopathy in Pediatric diseases

January 05 to December 05 Residential Medical officer
D.M.K.K., Dombivli

ACADEMIA

• Post Graduate Diploma in Clinical Research (PGDCR)
 Academy For Clinical Research, Mumbai
• December,2007 Secured First Class
 Involves detail training about
• Monitoring clinical trials with site initiation, PI meetings, site preparation, close out etc.
• International guidelines including FDA, Canadian, ICH with ICMR, Schedule-Y etc.
• Skills of managing project like Time, Cost, Risk and Resources management.
• Designing Protocol, CRF and ICF.

• M.S. in Counseling & Psychotherapy (Pursuing)
 Institute For Psychotherapy & Management Sciences

• Bachelor of Homoeopathy, Medicine and Surgery (BHMS)
 Maharashtra University of Health Sciences, Nashik, India
• December, 2004

ACADEMIC ACHIEVEMENTS

• Topper in Forensic Medicine & Toxicology in 2nd yr B.H.M.S. in S.H.M.C. Shirpur
• Stood 2nd in Final year B.H.M.S. in 2003 from S.H.M.C. Shirpur
• Secured Silver Medal in Homibhabha Young Scientist Award

ASSIGNMENTS UNDERTAKEN WITH ACE

• Importance of Informed Consent and Reconsenting in Clinical Trial.
• Preparation of protocol in fixed dose combination of Manidipine and Delapril.

SUBJECT EXPERTISE
CLINICAL RESEARCH
• Regulatory Affairs- includes
 All International and National Guidelines for GCP
E.g. ICH, FDA, Canadian, ICMR, Schedule-Y, Vaccination, Transplantation guidelines.
 Responsibilities- Monitor, Investigator, Sponsor, CRO.

• Project management- includes
 Detail study about what is project.
 Management skills like time, cost, risk, stress, resource etc.

• Ethics- includes
 Informed consent procedure & importance of informed consent.
 EC composition.

• Methodology- includes
 Guidance for industry 21 CFR part 11
 Practical issues in trial design
 E-trail

• Bio-statistic & Data management- includes
 ICH E-9
 Good clinical data management

COMPUTER SKILLS
 Well versed with applications such as Windows (95/98/XP) and Microsoft Office.
 Efficient use of the internet and possess exceptional keyboard skills.

PERSONAL OUTLINE

Name : Dr. Milind Jayant Phulmamdikar
Date of birth : 11th Nov 1981
Nationality : Indian
Marital Status : Single
Sex : Male
Language Proficiency : English, Hindi, Marathi
Learning Gujarati

REFEREES

Reference will be provided on demand

Dr. Milind Jayant Phulmamdikar

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