Clinical SAS professional offering 3+ years of experience in clinical research field with expert knowledge in clinical research regulatory requirements, study protocols, FDA, Good Clinical Practices, 21 CFR Part 11, HIPPA, CDISC, ICH guidelines and Standard Operating Procedures. Proven desire for achievement and continued professional growth.
Clinical data Coordinator, 11/2015 to Current Ascension – Novi, MI
Manage multiple oncology clinical trials simultaneously including Investigator-Initiated Trials as well as Industry Trials.
Responsible for day-to-day activities necessary to facilitate the successful completion of each study in accordance with study protocol and clinical research regulatory requirements.
Involved in recruitment, consenting, determining eligibility, enrolling, and coordinating care while on study.
Performed customized reports using sorting, PROC FREQ, PROC MEANS.
PROC SUMMARY for the datasets of patients enrolled in the study.
Created HTML, RTF, XML and PDF files using SAS/ODS facility.
Performed preliminary data validation of clinical trial data using PROC COMPARE.
Good understanding of Clinical Terminology and regulatory requirements.
Strong working knowledge regarding guidelines from ICH-GCP, 21CFR Part11, and SOP's and coding dictionaries such as MedDRA, WHODrug.
Biomed Informatics, Hyderabad India
Clinical SAS analyst
Biomed Informatics is training and services based enterprise, wherein I took up training and provided SAS Programming and analysis support for phase II (oncology) clinical trials project.
Data manipulation on SAS data sets using techniques such as merging, appending, concatenating and sorting.
Optimized performance using Data Validation and Data cleaning on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
Knowledge of regulation such as CDISC SDTM and ICH guidelines, also ADaM implementation of standardization for the analysis dataset.
Produced outputs in different formats such as HTML and PDF as requested by data management team.
Clinical Research Coordinator, 04/2014 to 09/2014 Karmanos Cancer Institute – Detroit, MI
Conducted activities of clinical research protocols including obtaining informed consent, reconsent, subject enrollment, subject eligibility criteria validation, maintaining patient charts.
Was responsible for submitting regulatory documents to WIRB like initial study approval, study amendments, annual continuations and terminations.
Performed documenting, reporting and follow-up with adverse events as necessary.
Maintained regulatory binders and all the communications done with IRB and sponsors.
Maintained detailed study related logs, and updated CTO OnCore database in a timely manner.
Resolved data queries in a timely manner.
E-clinic SAS analyst, 05/2012 to 12/2012 Zifo Technologies – Chennai, India
Zifo technologies Pvt.
Ltd is specialized Clinical Research Data Management service provider.
During that period I was trained in GCP, 21 CFR Part 11, CDISC, SDTM, CDASH standards.
Reviewed Protocols, Case Report Forms and Statistical Analysis Plans for clinical trials.
Validated SAS programs that produce derived/analysis datasets and analyses specified in the Statistical Analysis Plan.
EDC (Electronic data Capture) - CRF/eCRF designing, study validation and edit checks for products like Openclinica, e-capture.net, ClinCapture, Viedoc etc.
Successfully performed E-Workbook/ BioBook ELN 9.2 validation, and also involved in test execution.
Student Research Associate, 11/2011 to 04/2012 Alagappa University – Karaikudi, India
Performed an independent research work on genomics of Thermus thermophilus HB8 species.
Assisted students for finding homology sequences for the target proteins using BLAST, ExPASY, Clustal W databases.
Performed routine tasks related to molecular dynamics, protein structure validation, Active site prediction, stability validation, docking studies etc.
M.S: Clinical Research Administration, Eastern Michigan University - USA. Clinical Research Administration
Master's: Patient's perception of cancer related Depression/Anxiety during their treatment. March, 2017.
B.Tech - Biotechnology (4 years)
PSR Engineering College, Anna University Affiliation, Tamilnadu India.
Undergraduate Thesis: Computational Modeling, Molecular Dynamics Simulations, & Docking Studies of Multidrug-efflux Transporter from Thermus thermophilus HB8. April, 2012.
CITI Good Clinical practices, License 17954964 || CITI-HIPPA, License 17613865
National Institutes of Health - Protecting Human Research Participants, License 2021024
Attended IRB Training session at Wayne State University on the topics:
*The IRB Process for Exempt Research Projects
*Research Involving Drug, Devices, and Biologics
*Achieved University fourth rank among 120 students in Anna University, Tamilnadu, India.
*Excelled as best Out-going student award and many academic awards during 2008-2012.
*Enhanced clinical research accuracy by 30% through implementation of effective, contemporary clinical research methodology and data collection/validation strategies.