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<pre>Array ( [var] => cut_url ) </pre> Resume for Karna C. for Researcher / Scientist / Biotechnology & Pharmaceuticals in Bangalore City, India. Search More Resumes for Researcher / Scientist on Resumark.com #WWU7EODKV
 

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Resume for Karna C. for Researcher / Scientist / Biotechnology & Pharmaceuticals in Bangalore City, India




Occupation: Researcher / Scientist Industry: Biotechnology & Pharmaceuticals
Country: India City: Bangalore City
State: Karnataka ZIP: 560060



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KARNA C. A                                    

House No., Jeelugula, Karimnagar, India

Contact: + , ; Email:       

CLINICAL RESEARCH PROFESSIONAL

Seeking a challenging and rewarding opportunity in the industry which is in line with my academic background and which effectively utilizes my analytical and technical skills  

PROFILE  

  • Trained and Certified professional, offering a comprehensive experience of over years in Clinical Research. Currently handling the responsibility as Monitor & Senior Clinical Research Coordinator with Suven Victa,  a division of Suven Life Sciences.
  • Possessing core competencies in PreClinical Research and Clinical Trials Phases IIV and performing Site Selection, Initiation, Monitoring, Recruitment, Retention, Compliance and Study Closeout activities in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements.
  • Well versed in Clinical Trial Procedures, Standard Operating Procedures SOPs, Protocol, Good Clinical Practice GCP, and possess ability to apply GCP/ICH Guidelines, IND Submission and IRB/IEC Regulations.
  • Comprehensive experience conducting trials and scientific study of effects, risks, efficacy and benefits of pharmaceutical products. Proven ability in administering Quality Control procedures and well equipped Good Clinical Practices.
  • Proficient in handling SAE forms like CIOMS, CDSCO. Articulate communicator with a strong work ethic, continuously striving for improvement coupled with excellent administrative aptitude with an eye for detail and the commitment to offer quality work.
  •  

    PROFESSIONAL EXPERIENCE 

    SUVEN VICTA, A DIVISION OF SUVEN LIFE SCIENCES PVT LTD, BANGALORE                    since Jun’ Monitor & Senior Clinical Research Coordinator 

  • Participating in clinical site initiation visits; advises and trains site personnel on protocol and regulatory requirements for study conduct; participates and/or conducts site meetings.
  • Conducting of site internal monitoring to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with SOPs, ICH GCP guidelines.
  • Reviewing of onsite files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
  • Assisting the study coordinator and monitor during the transmission of clinical case data to the data management unit, close out visits etc.
  • Reviewing the TMF in a timely manner to ensure that up to date study documents are placed in them and attending the Project team meetings and providing site updates to the project team
  • Updating the daily report to Quality control manager and organizing for the sponsor's Audit.
  • Handling safety data of various drugs in different phases of trial as well as marketed drugs. Receive followup and report adverse events.
  • Reviewing and process adverse events reported by Investigators. Prepare Safety report as per ScheduleY format to be reported to regulatory authorities and also other investigators, who are part of the study.
  • Researching and providing medical and scientific information to health care professionals and to various functional areas within the company.
  • Conducting and analyzing, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries.
  • Reviewing clinical trial protocols, bioequivalence study protocols and provide inputs, support the clinical trial team
  • Generating concise, accurate and wellwritten case narratives and code medical information as per given standard operating procedures.
  • Responsible for effective and efficient development of the safety management plan, including development of specific processes to assure consistency within the project.
  • Effectively maintaining the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process.
  • Performing consistent coding of diseases, adverse events, and medication according to the projectspecific coding conventions.
  • Supporting the generation of Annual Safety Updates, Periodic Safety Reports, and other cumulative safety reports including data retrieval, analyses and quality control and reconciling the SAEs in accordance with project specific guidelines.
  •  

    GLOBAL CLINICAL RESEARCH SERVICES PVT LTD, HYDERABAD AND BANGALORE                  

    It is an Initiative of Global group Hospitals        

    Monitor & Senior Clinical Research Coordinator                                           Apr’Jun’

    InHouse Monitor & CRC                             Mar’Mar’ 

  • Responsible for Clinical Research studies and ensured that they are conducted in accordance with the protocol, standard operating procedures, good clinical practice as well as applicable regulatory requirements.
  • Obtained and processed regulatory and administrative documents from investigator sites. Compile and format Clinical and Regulatory data for submission to regulatory agencies in standardized format using electronic tools.
  • Coordinated with authoring departments to finalize Clinical Trial documents and ensure that all clinical and nonclinical data is ready for submission and all components are compiled, accessible in the correct format according to established regulations, guidelines, SOP to reflect information/data from source documents.
  •  

    Clinical Trials Undertaken

  • Phase III: Metastatic Breast Cancer, VTE, Cislpatin Chemotherapy
  • Phase II & III: Chronic Hepatitis C Genotype , &
  • Phase III & IV: Orthopedics 
  • Phase II & III: Cardiology 
  • Phase II & III: Pulmonology 
  • Phase II & III: Diabetology 
  •  

    MEDWIN HOSPITALS, HYDERABAD                                   Jun’Feb’

    Clinical Trial Assistant 

    ICICI DIRECT, HYDERABAD                 Nov’Jan’

    Team Lead 

    EDUCATIONAL CREDENTIALS 

    Pursuing Master of Business Administration, Project Management

    Sikkim Manipal University Distance Education 

    Completed a Certification course in Clinical TrialsTraining, Biostatistics and SAS Clinical

    Biomed Informatics, Medwin Hospitals, Hyderabad 

    Master of Science, Biotechnology

    Bharathidasan University, Tamilnadu; % 

    Bachelor of Science, Microbiology

    Kakatiya University, Warangal; % 

    Class XII

    Kakatiya Junior college; % 

    Class X

    Arunodaya Gurukula Vidhyalayam; % 

    Technical Skills

    MS DOS, MS Office, Windows //XP & Internet Applications 

    Dissertations Undertaken 

    Title A detailed study on the effect of various Carbohydrates and Ph parameters in the production of BioPetrol from Saccharomyces Cervisiae
    Organization Nthrys Biotech Labs, Hyderabad.
    Synopsis A project to study the production & concentration of  Biopetrol using  by different types of media’senergy sources and various Ph parameters with the help of small fermentors like liters to liters. Concentration has been analyzed by using potassium dichromate in the titration process.
    Team
     
     

    Projects Undertaken

  • Undertook a project on Master data analysis of migraine Investigational drug with the Comparative drug.
  •  

    Workshops Attended

  • Attended certificate program in Clinical research by Quintiles
  • Attended online NIH GCP workshop & Quintiles GCP certificate program
  • Participated in GCP workshop & opportunities in Clinical Research at Global Hospitals, Hyderabad in Jan .
  • Participated in Workshop on Clinical Research in NIMS, Hyderabad on Aug .
  •  

    Date of Birth: May st,

    Language Proficiency: English Hindi, Telugu, Tamil and Kannada

    References: Available on Request


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