Clinical Research Associate - Biotech Resume Search
Clinical Research Associate - Biotech Resume Search
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Clinical Research Associate Resume


Desired Industry: Biotech SpiderID: 79426
Desired Job Location: Greenbelt, Maryland Date Posted: 6/19/2017
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 60000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel:
Highest Degree Attained: Bachelors Willing to Relocate: Yes


Objective:

Highly analytical, performance-focused, and innovative professional, with extensive experience in clinical research, data analysis

and verification, regulatory compliance, and medical laboratory operations. Highly familiar with practice harmonization techniques

of International Conference on Harmonisation (ICH), Good Clinical Practice (GCP), FDA regulations, and Standard Operating Procedures

(SOPs). Armed with investigative and problem-resolution skills in performing clinical trial monitoring processes, on-site visits,

case report evaluations, and programming preparation. Articulate communicator, with bilingual fluency in English and Persian.

Technically proficient with Microsoft Office Suite and SAS software.


Experience:

Clinical Experience

Amarex Clinical Research - Germantown, MD
Clinical Data Administrator 2013–Present
Take charge of the preparation of programming tables and listing templates; as well as monitoring of case report forms (CRFs),

project documents, supplies, and enrollments.
Provide hands-on assistance to other groups or inclusions in conducting quality checking of data listings and tables prior to

transmission to other groups as well as inclusion in interim and final reports.
Employ keen attention to detail in conducting clinical trial data sets and CRFs to address errors, discrepancies, and protocol

violations.
Perform data handling and database validation and execute data entry conventions in adherence to company procedures, while ensuring

on-time and accuracy of database completion.
Hold accountability in supporting regulatory submissions through clinical study database management.
Keep abreast of the regulatory requirements in facilitating data processing operations.
Work collaboratively with involved internal and external individuals in accomplishing projects, along with the study team in

evaluating case report data and handling data queries.
Fulfill key tasks in converting clinical study datasets to Study Data Tabulation Model (SDTM) of the Clinical Data Interchange

Standards Consortium (CDISC).
Maintained active participation in project team meetings to develop process recommendation, which led to the timely and successful

completion of administrative tasks.



Research Experience

University of Guelph, Department of Molecular and Cellular Biology - Guelph, ON, Canada
Research Project 2011–2012
Conducted research to study epigenetic mechanisms controlling gene expression at telomere in budding yeast.
Developed cloning and expression vectors in Escherichia coli and saccharomyces cerevisiae, while creating electro-competent and

chemically competent Escherichia coli cells.
Applied in-depth knowledge and experiences in cloning, recombinant DNA, and bacterial transformation techniques in performing

laboratory tasks.
Demonstrated competency in conducting PCR, RT-PCR, gel electrophoresis, plasmid purification, DNA and RNA extraction, protein

purification, SDS-PAGE, Western and Southern blotting techniques; as well as immunofluorescence, ELISA, and flow cytometry.
Utilized skills in laboratory equipment, including microscopes, centrifuges, balances, spectrophotometers, incubators, autoclaves,

pH meters, biological safety cabinets, PCR machines, and electroporators.

University of Guelph, Department of Food Science - Guelph, ON, Canada
Research Technician 2011–2012
Initiated the development of a new method for moisture migration control.
Displayed technical skills in creating a model that resembled moisture migration in biological systems.
Contributed significant inputs in developing laboratory instruments for new projects.

Earlier Positions Held:
Shiraz University of Medical Sciences
Professor Alborzi Clinical Microbiology Research Centre - Shiraz, Fars, Iran
Clinical Research Technician

Boo-Ali Medical Laboratory - Shiraz, Fars, Iran
Medical Laboratory Technician

Baladeh Health Center - Kazeroon, Fars, Iran
Medical Laboratory Technician


Education:

Education

Bachelor of Science in Molecular Biology and Genetics, Honors Degree
University of Guelph, Guelph - ON, Canada
Graduated with Distinction

Associate’s Degree in Medical Laboratory Sciences
Shiraz University of Medical Sciences - Shiraz, Fars, Iran



Certifications

Certified Clinical Research Professional (CCRP)
United States Food and Drug Administration (FDA) Clinical Investigator Training Course
Statistical Analysis System (SAS) Programming Certificate


Affiliations:



Professional Affiliation

Member, The Society of Clinical Research Associates (SOCRA)


Skills:


Professional Development

Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) Training, 2013, 2014, 2015, 2016
Electronic Data Capture (EDC) Training, 2014, 2015, 2016, 2017
Laboratory Safety and Workplace Hazardous Materials Information System (WHMIS) Training, 2011



Awards and honors

Token of Appreciation for Research and Publications
Token of Appreciation for Facilitation of Educational Workshops
Vice-Chancellor of University and Health Undersecretary, Fars Province, Iran


Additional Information:


Publications

Abbas, B. B., Abdolvahab, A., Gholamali, Y. P., Roshanak, B., and Rashidi, M. (2003). Clinical signs as a guide for performing HSV-

PCR in correct diagnosis of herpes simplex virus encephalitis. Neurol India, 51(3), 341-344.
Alborzi, S., Pourabbas, B., Rashidi, M., and Astaneh, B. (2006). Aflatoxin M1 contamination in pasteurized milk in Shiraz (south of

Iran), Food Control, 17(7), 582-584.
Alborzi, A., Soltani, J., Pourabbas, B., Oboodi, B., Haghighat, M., Hayati, M., and Rashidi, M. (2006). Prevalence of helicobacter

pylori infection in children (south of Iran). Diagnostic Microbiology and Infectious Disease, 54(4), 259-261.
Alborzi, A., Aelami, M., Astaneh, B., Pourabbas, B., Farshad, S., Kalani, M., ... Rashidi, M. (2008). Is Escherichia coli O157:H7 a

common pathogen in children with bloody diarrhea in Shiraz, Iran? Turkish J Pediatrics, 50(4), 349-353.
Behzad-Behbahani, A., Mafi-Nejad, A., Tabei, S. Z., Lankarani, K. B., Rashidi, M., Rasouli, M. R., ... Salah, A. R. (2005).

Indication of anti-HBc antibody screening and HBV-DNA detection in diagnosing latent hepatitis B virus infection. Iranian Journal of

Medical Sciences,30(1), 28-33.


Reference:
Available upon request.


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