Objective:

Seeking for the position in Clinical Research Industry rendering competitive environment that will utilize my experience in designing, researching, analyzing and monitoring clinical trials of multiple projects will ensure quality, safety and reliability of the products.

Summary:

Around 5years of experience in Clinical Research Industry.

3 years of Monitoring and SAS Programming, SQL experience.

Maintained Laboratory Regulatory Compliance.

Worked with Clinical Data Management tools Openclinica and Adobe Lifecycle,

Medidata.

Worked with different IVD (In-Vitro Diagnostic) devices.

Involved in the implementation of Project Plans related to the Clinical Monitoring responsibilities.

Good Knowledge of the Drug development process, Clinical research process and Medical terminology.

Experience in Monitoring Phase I, II, III & IV Clinical Trials.

Managed projects under therapeutic areas.

Thorough knowledge on all relevant regulations including GMP, GCLP, GCP, ICH guidelines, 21 CFR, pharmacovigilance, Trial Master Plan (TMP), clinical trials and IRB guidelines, HACCP, Food Safety and Knowledge on HEDIS.

Assisted with Protocol development, Design and review, verification and validation, sample and study documentation, data collection, interpretation and analysis.

Developed and assisted in development of study design, protocols, case report forms(CRFs) and other study-specific documents essential to appropriate implementation of clinical investigations.

Maintained accurate, legible and complete laboratory records.

Laboratory experience and working knowledge in quality control checks, solutions preparations and standardizations and calibrations

Expertise in using SAS procedures such as Tabulate, Report, Transpose, Sort, SQL, Means, Freq and ODS.

Expertise in generating the Safety and Efficacy tables by using SAS programming.

Experience in SAS Enterprise guide.

Proficiency in SAS Programming 9.3 (Base SAS - SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS)

Knowledge on SQL.

Worked on Immunology Assays. Performed ELISA using Blood samples

Good knowledge in Molecular Biology that includes all the techniques: PCR, qPCR, Electrophoresis, SDS PAGE, Isolation of genomic & plasmid DNA

Experience working in Protein Purification on Enzymes and HPLC on Antioxidants.

Undergone training in Digital Advanced Molecular Biology.

Biomolecular techniques – spectroscopic & colorimetric determinations, chromatographic techniques (paper, TLC, ion exchange, etc.), biochemical test for proteins, carbohydrates & oils.

Involved in Qualitative determination of DNA, RNA & Proteins.

Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

Excellent organizational, editorial and interpersonal skills.

Skills & Abilities:

Operating systems : Windows 8,10

MS Office : Word, Excel, PowerPoint and Outlook

Statistical tools : Base SAS v 9.3

Clinical Software : OpenClinica and Adobe Lifecycle.

Certifications:

Base SAS(9.3) Certified.

Trained in Clinical Data Management and SAS from India.

Clinical Research Associate /

Junior SAS Programmer Aug 2012 – Sep2015

Global Clinical Research Services Pvt. Ltd, India

Global Clinical Research Services (GCRS) is a comprehensive site management organization serving the Biopharmaceutical and Medical Device Industry.

Responsibilities:

Responsible for monitoring sponsor initiated and federally funded clinical research studies for normal volunteers and subjects diagnosed with Disease.

Assisted in the implementation of Project Plans related to the Clinical Monitoring Responsibilities

Worked with Medical devices where (Low Risk level, moderate individual risk level, High Individual risk level) was estimated with devices.

Worked with different IVD (In-VitroDiagnostic) devices like Blood Glucose Testing, Urine Test strips, Pregnancy test, clinical chemical analyzer, vitamin B12.

Conducted the Clinical Monitoring aspects of Protocols for 3-4 Sites.

Determining and reporting adverse events appropriately within the time periods required by GCP, the protocol, the IRB, the sponsor and regulatory all AE and SAE's.

Monitoring the trial throughout its duration by visiting each study center on regular basis (pre-study visit, site initiation visit, site monitoring visit, site closeout visit).

Verifying the data entered on to CRFs is consistent with patient clinical notes known as Source Data /Document Verification (SDV).

Collecting Completed CRFs from hospitals(sites).

Writing Monitoring Visit reports (Site Visit Reports).

Ensuring all unused trial supplies are accounted (Study Close Outs).

Closing down study centers on completion of the trial (Study Closeout Process).

Discussing results with Medical Statisticians.

Interaction and communication with Principle Investigator and study nurses, logistic support to the medical team, quality control on data and processes with primary focus on patient safety.

Conducted internal site monitoring to identify significant problems and to ensure that all clinical aspects of studies are being carried out in accordance with the protocol requirements, SOPs and ICH GCP guidelines.

Review of on-site files and records, Informed Consent Form, Informed Consent process documentation, source documents and case report forms for completeness, accuracy, consistency, and compliance.

Standard domains and review CRF’s to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in protocol.

Reviewed the Trial Master File in a timely manner to ensure that up to date study documents are placed in them.

Communicating the Ethics committee (EC) for the study documents submissions and follow-up the approval of the study and submission of study related documents and safety reports to the Ethics Committee after the approval accordingly.

Responsible to check lab samples have been taken and handled/shipped/stored as per the instructions provided in the lab manual.

Coordinate the study team meetings and activities. Responsible for the preparation of accurate timely monitoring visit reports and execution of Investigator meetings.

Used SAS/BASE to perform Sorting, Merging of Clinical Data and generated reports.

Used SAS Enterprise Guide for clinical trial data analysis.

Extensively worked on Data Mapping from existing raw data to CDISC SDTM.

Responsible for creating data sets, listings and reports for clinical trials data.

Worked with the Statisticians, Data managers to provide SAS programming in analyzing clinical Trial Data, generating final study, tables and listings.

Involved in validations, edit checks and extensively used the procedures like REPORT, SUMMARY, TABULATE, FREQ, TRANSPOSE, UNIVARIAE, SORT, MEANS.

Assisted in review and resolution of data queries, data review and collection, Regulatory document review

Ensured optimal quality of medical care for patients participating in a study.

Clinical Research Associate May 2011 – Mar2012

JNT University, India

Responsibilities:

Perform data abstraction, collection, and entry to support clinical research

Prepare submission for all reportable events (e.g., adverse events, protocol variations, etc.)

Develop, maintains, and/or monitors case report forms.

Ensure compliance with prescribed interventions and evaluations of the assigned protocol(s)

Provide data to the collaborating research organization (CRO) or study sponsor

Prepare data reports

Perform other related duties as directed to meet the goals and objectives of the department and the institution

Provide regular updates on all lab recruitment for respective studies

Collaborate with additional labs and clinics for study recruitment

Research Assistant Jul 2010 – Apr 2011

Bioworld Research Technologies, India

Assisted Research professor in Protein Purification and to detect Alkaline Protease Activity. This study was embarked upon investigating nutritionally important aspects of protein biology.

Responsibilities:

Worked as an Intern in the quality control department with respect to reviewing and auditing quality control data.

Successfully assisted researchers with experiments for the purification of proteins.

Worked with Protein purification techniques like Native PAGE, SDS PAGE & protein estimation.

Detection of Alkaline Protease Activity in cotyledons of Glycine max seedlings by Activity Zymogram Staining.

Alkaline protease activity was assayed using different varieties of Beans and Legumes.

Protease present in seedlings of soybean was assayed by Anson’s method of tyrosine estimation.

Protein content in germinated and un-germinated seedlings was estimated by Folin-Lowry method.

SDS PAGE was performed to view protein bands.

Activity of Alkaline protease activity was visualized in the Gelatin Zymogram.

Assisted with Protocol development, Design and review, verification and validation, sample and study documentation, data collection, interpretation and analysis.

Lab Assistant May 2009 –Jun2010

Best Biotek Research Labs Private Limited, India

Assisted a Research professor in Molecular Biology Techniques.

Responsibilities:

Arranged media, buffers and plates for sterilization techniques.

Maintained accurate, legible, and complete laboratory records

Hand on experience in molecular biology techniques includes PCR, qPCR, Electrophoresis, SDS PAGE, Isolation of genomic & plasmid DNA

Immunological Techniques include ELISA, Western Blot, Immunohistochemistry, Immunocytochemistry performed using blood samples.

Qualitative determination of DNA, RNA & proteins

Education:

BASE SAS 9.3 Certified.

Trained on Clinical Data Management and SAS 9.3, India.

Bachelors in Life Sciences from Osmania University, June 2007

Masters in Biotechnology from Bangalore University, June 2009

References:

Available upon request.

Contact this candidate