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House No., Jeelugula,
, ; Email:
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
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.
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.
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
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
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.
the safety database and corresponding entry guidelines, including accurate
entry of data and assurance of quality of data through quality control
Performing consistent coding
of diseases, adverse events, and medication according to the projectspecific
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.
RESEARCH SERVICES PVT LTD, HYDERABAD AND BANGALORE
It is an Initiative
of Global group Hospitals
Monitor & Senior
Clinical Research Coordinator
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
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
Clinical Trial Assistant
ICICI DIRECT, HYDERABAD
of Business Administration, Project Management
Sikkim Manipal University
Completed a Certification
course in Clinical TrialsTraining, Biostatistics and SAS Clinical
Medwin Hospitals, Hyderabad
Master of Science,
Bachelor of Science,
Kakatiya Junior college;
MS DOS, MS Office,
Windows //XP & Internet Applications
|| A detailed study on the
effect of various Carbohydrates and Ph parameters in the production
of BioPetrol from Saccharomyces Cervisiae|
|| Nthrys Biotech Labs, Hyderabad.|
|| 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.|
Undertook a project on Master
data analysis of migraine Investigational drug with the Comparative
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:
English Hindi, Telugu, Tamil and Kannada
Available on Request