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Clinical Research Associate Resume Sample, Experience : 3 years

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Name of the Candidate:[Private]
Name of the Post Applied:Clinical Research Associate
Job related skills / software:Clinical Trial, Preparation Planning, Development
Sub Category:Clinical Research
Years of Experience:3 years
State:Andhra Pradesh
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:M.Sc. / MSC : Master of Science
Major / Specialization:Biotechnology
Email Id:[Private]
Are you looking for job now?:No
Can the recruiter contact you?:No
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Resume Format / CV Sample Template / Example / Model :


Objective :
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.
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(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 University
**    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, India
Technical 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. Office
**    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.
I hereby declare that the particulars provided above are true & correct to the best of my Knowledge.


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