To work for a leading, dynamic and challenging organization in the area of clinical trials, where my experience, accomplishments are put to best use.Professional Summary:
** 2 Year and 10 months of experience in clinical trials as a Clinical research coordinator.
** Clinical Trial preparation involving planning, development and evaluation of patient information and inform consent forms.
** Regulatory/Ethical submission and communication with relevant authorities
** Determining eligibility based on inclusion exclusion criteria.
** Enrollment and follow up of recruited subjects to minimize dropouts
** Performing the trials according to the protocol and GCP.
** Maintenance of investigator files at the site.
** Management of Trials at the site.Work Experience:
** Currently working as a Clinical Research Coordinator (CRC) since Nov-30-2009 in CREW SMO INDIA Pvt Ltd, Hyderabad.
** Worked as a Clinical Research Coordinator (CRC) from Jun-2008 to 25-Nov 2009 at Clinical Research Centre in Apollo Health City, Under Dr.P.C.RATH
For Device trials in the Cardiology Department Apollo Hospitals, Hyderabad.Responsibilities as Coordinator:
** Coordinate site selection and study feasibility assessments.
** Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals.
** Recruitment and co-ordination of trial subjects covering informed consent, screening and visit coordination.
** Ensure that IRB approval of protocol and informed consent form is obtained prior to initiation of the study.
** Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
** Confer with subject and physician to explain purpose of study. Coordinate to obtain written consent for subject to participate in a study prior to initiation of any protocol procedures.
** Maintain accurate records of the receipt, inventory, and dispensation of study drug and materials.
** Obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
** eCRF filling (Inform, Mednet,Oracle base Data management)
** Case Record Form filling.Education Qualification:
** M.Sc. Sponsored links :
(BIOTECHNOLOGY), 2005-2007, Yeswanth college of IT (Biotechnology & bioinformatics), S.R.T.M University (Nanded).
** B.Sc. (Biotechnology, Chemistry & Biochemistry), 2002-2005, Chaitanya Degree College, Kakatiya UniversityTraining:
** Attended training on “Fundamentals of Clinical Research and GCP" with Subject Matter Expert Dr. Arun Bhatt and was awarded certification by Academy for Clinical Excellence, Bombay School of Pharmacy.
** Attended training on different Clinical data bases (Inform, Oracle based Data management)
** Succesfully participated in GCP training for phase II clinical trail conducted by Torrent pharmaceuticals limited, IndiaTechnical Skills:
** 21 CFR Part 11, ICH-GCP, Schedule “Y”, ICMR, FDA Guidelines, CRF, BA/BE Studies, Knowledge of Computer usage in a web-based environment, Strong collaboration and team building skills.
** Good working knowledge on different Clinical data bases (Inform, Oracle based Data management).Software Skills:Operating system : Windows Package : M.S. OfficeStrengths:
** Able to work effectively and efficiently in a matrix environment.
** Capable of working independently as well as in a team.
** Self-motivated & target oriented.
** Eye for detail and Quality.Declaration:
I hereby declare that the particulars provided above are true & correct to the best of my Knowledge.
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