SlideShare a Scribd company logo
1 of 1
Download to read offline
RAHUL GUNASEKERA
Bachelor of Science: Microbiology
University of California Santa Barbara
rahulgunasekera@gmail.com  661-860-6104
A dynamic, efficient, analytical researcher with an avid interest developing expertise to create and develop a tactical role
within a regulatory affairs environment. Past experience includes both clinical and laboratory research with reputed
physicians and scientists.
WORK EXPERIENCE
California Medical Research Associates – Clinical research coordinator – May 2014 – Present
 Contract with pharmaceutical sponsors to conduct clinical drug trials on patients
o Sponsors include Pfizer, Amgen, Roche, Salix, Bayer, Janssen, etc.
 Manage trial from implementation to completion satisfying all regulatory standards dictated by governing bodies
 Collaborates and communicates cross-functionally with doctors, patients, and pharmaceutical representatives
 Completes and compiles all documentation necessary to meet regulatory standards which include FDA submissions, electronic
case report forms, and developing and implementing SOPs
 Prepares and submits internal regulatory file applications and supporting documentation
 Responsible for the daily handling and accountability of investigational products
 Working knowledge of ICH Good Clinical Practice guidelines
Hema-Tek Histological Svc – Surgical/histological lab technician in MOH`S micrographic surgery – January 2014 – Present
 Process tissue samples from skin cancer patients using a hematoxylin and eosin stain to be viewed by a MOHS surgeon under
the microscope
 Use a microtome cryostat to cut histological slides, allowing rapid diagnosis in the operating room, for the surgical excision of
cancer
 Troubleshoot machine malfunctions
 Currently working at Loma Linda Medical University with Abel Torres, MD and Andrea Smith, MD
o Educate and train new medical residents and staff about MOHS procedure and methods
SCHOOL EXPERIENCE
Howard Hughes Medical Institute research program – 2012
 Assist researcher in conducting three novel experiments headed by post docs
Student Lab Assistant - 2012-2013
Laboratory of Dr. Anthony De Tomaso, Department of Molecular, Cellular, and Developmental Biology, UC Santa Barbara
 Utilize microscopy and staining techniques necessary for fluorescent microscopy including Phalloidin assay, TUNEL assay on the
model organism Botryllus schlosseri
Immunology Lab Student – 2013
 Culture a mammalian cell line from mouse thymus and spleen cells
 Develop lab reports and analyze results using Microsoft Excel, ImageJ, and Guava Soft Incyte software for flow cytometry
Co-founder of Immunology Club in UCSB 2012-2013
 Present both personal research and relevant research articles focused on current immunology subject matter to peers and
faculty
LAB SKILLS
Microscopy DNA Extraction Cell Culture ELISA Western Blot Sterile Technique PCR/Cloning Flow Cytometry

More Related Content

What's hot (20)

RESUME
RESUMERESUME
RESUME
 
Jeanne wendtland ccp13
Jeanne wendtland ccp13Jeanne wendtland ccp13
Jeanne wendtland ccp13
 
John Werbitsky-Resume
John Werbitsky-ResumeJohn Werbitsky-Resume
John Werbitsky-Resume
 
Gessner_Brent_Resume
Gessner_Brent_ResumeGessner_Brent_Resume
Gessner_Brent_Resume
 
Information Visualization in Medical Informatics
Information Visualization in Medical InformaticsInformation Visualization in Medical Informatics
Information Visualization in Medical Informatics
 
Shneiderman info vismedical-amia-panel-v2
Shneiderman info vismedical-amia-panel-v2Shneiderman info vismedical-amia-panel-v2
Shneiderman info vismedical-amia-panel-v2
 
cuvalledec12resume
cuvalledec12resumecuvalledec12resume
cuvalledec12resume
 
Resume 10-16
Resume 10-16Resume 10-16
Resume 10-16
 
cv (4)
cv (4)cv (4)
cv (4)
 
WGBMEResume
WGBMEResumeWGBMEResume
WGBMEResume
 
Resume
ResumeResume
Resume
 
resume4
resume4resume4
resume4
 
Howeth, Debra resume 2016
Howeth, Debra resume 2016Howeth, Debra resume 2016
Howeth, Debra resume 2016
 
Faces of Success: Terence Ho ccp13
Faces of Success: Terence Ho ccp13Faces of Success: Terence Ho ccp13
Faces of Success: Terence Ho ccp13
 
neutralresumemergui17
neutralresumemergui17neutralresumemergui17
neutralresumemergui17
 
Porter, W. M. 112.004
Porter, W. M. 112.004Porter, W. M. 112.004
Porter, W. M. 112.004
 
Resume*
Resume*Resume*
Resume*
 
Resume-Adam Nathan
Resume-Adam NathanResume-Adam Nathan
Resume-Adam Nathan
 
Edward Asner Resume_Updated 20NOV2016
Edward Asner Resume_Updated 20NOV2016Edward Asner Resume_Updated 20NOV2016
Edward Asner Resume_Updated 20NOV2016
 
SaaS: Science as a Service
SaaS: Science as a Service SaaS: Science as a Service
SaaS: Science as a Service
 

Viewers also liked

18 Carmen Ardelean- CAVALER AL CETATII
18 Carmen Ardelean- CAVALER AL CETATII18 Carmen Ardelean- CAVALER AL CETATII
18 Carmen Ardelean- CAVALER AL CETATIIEmanuel Pope
 
LICENSE COPY AND CICPA PASS
LICENSE COPY AND CICPA PASSLICENSE COPY AND CICPA PASS
LICENSE COPY AND CICPA PASSMOHAMMAD AZAD
 
resumen de los videos
resumen de los videos resumen de los videos
resumen de los videos Noemi Chimbo
 
DF merchant services
DF merchant servicesDF merchant services
DF merchant servicesinfographads
 
Alameda perez. tarea 5
Alameda perez. tarea 5Alameda perez. tarea 5
Alameda perez. tarea 5Eco-Life
 
De magistris i poteri forti mi perseguitano.
De magistris i poteri forti mi perseguitano.De magistris i poteri forti mi perseguitano.
De magistris i poteri forti mi perseguitano.Daniela Petrecca
 

Viewers also liked (9)

Más dura será la caída
Más dura será la caídaMás dura será la caída
Más dura será la caída
 
1st reflection
1st reflection1st reflection
1st reflection
 
18 Carmen Ardelean- CAVALER AL CETATII
18 Carmen Ardelean- CAVALER AL CETATII18 Carmen Ardelean- CAVALER AL CETATII
18 Carmen Ardelean- CAVALER AL CETATII
 
LICENSE COPY AND CICPA PASS
LICENSE COPY AND CICPA PASSLICENSE COPY AND CICPA PASS
LICENSE COPY AND CICPA PASS
 
resumen de los videos
resumen de los videos resumen de los videos
resumen de los videos
 
Img 0002
Img 0002Img 0002
Img 0002
 
DF merchant services
DF merchant servicesDF merchant services
DF merchant services
 
Alameda perez. tarea 5
Alameda perez. tarea 5Alameda perez. tarea 5
Alameda perez. tarea 5
 
De magistris i poteri forti mi perseguitano.
De magistris i poteri forti mi perseguitano.De magistris i poteri forti mi perseguitano.
De magistris i poteri forti mi perseguitano.
 

Similar to Rahul Gunasekera Regulatory Affairs Profile

Similar to Rahul Gunasekera Regulatory Affairs Profile (20)

Samuel's CV.
Samuel's CV.Samuel's CV.
Samuel's CV.
 
Malvyn Fairclough Data Science CV
Malvyn Fairclough Data Science CVMalvyn Fairclough Data Science CV
Malvyn Fairclough Data Science CV
 
Marc Musolino Resume 2016
Marc Musolino Resume 2016Marc Musolino Resume 2016
Marc Musolino Resume 2016
 
DanaM 0116 plus R6
DanaM 0116 plus R6DanaM 0116 plus R6
DanaM 0116 plus R6
 
Thomas Cayton Grad Resume CA
Thomas Cayton Grad Resume CAThomas Cayton Grad Resume CA
Thomas Cayton Grad Resume CA
 
Ab. Tariq CV
Ab. Tariq CVAb. Tariq CV
Ab. Tariq CV
 
CV Larissa Rugg_23Mar2016
CV Larissa Rugg_23Mar2016CV Larissa Rugg_23Mar2016
CV Larissa Rugg_23Mar2016
 
KristenLBeuving-Word CV(05-15)
KristenLBeuving-Word CV(05-15)KristenLBeuving-Word CV(05-15)
KristenLBeuving-Word CV(05-15)
 
Resume_BB
Resume_BBResume_BB
Resume_BB
 
Resume
ResumeResume
Resume
 
Elisa Renee Swartz Resume April 2015
Elisa Renee Swartz Resume April 2015Elisa Renee Swartz Resume April 2015
Elisa Renee Swartz Resume April 2015
 
Dr. SUE ELIZABETH SHAJAN CV 2016[1]
Dr. SUE ELIZABETH SHAJAN CV 2016[1]Dr. SUE ELIZABETH SHAJAN CV 2016[1]
Dr. SUE ELIZABETH SHAJAN CV 2016[1]
 
Kalyan Resume
Kalyan ResumeKalyan Resume
Kalyan Resume
 
Martha ariza resume
Martha ariza  resumeMartha ariza  resume
Martha ariza resume
 
Marcus-Yaffee-Flier
Marcus-Yaffee-FlierMarcus-Yaffee-Flier
Marcus-Yaffee-Flier
 
resume update
resume updateresume update
resume update
 
OscarLara_resume_2015current
OscarLara_resume_2015currentOscarLara_resume_2015current
OscarLara_resume_2015current
 
Nesreen Jawhari Resume 2015
Nesreen Jawhari Resume 2015Nesreen Jawhari Resume 2015
Nesreen Jawhari Resume 2015
 
Tumour models London 1-3 December 2015 Agenda
Tumour models London 1-3 December 2015 AgendaTumour models London 1-3 December 2015 Agenda
Tumour models London 1-3 December 2015 Agenda
 
MAUREEN AKINYI CV
MAUREEN AKINYI CVMAUREEN AKINYI CV
MAUREEN AKINYI CV
 

Rahul Gunasekera Regulatory Affairs Profile

  • 1. RAHUL GUNASEKERA Bachelor of Science: Microbiology University of California Santa Barbara rahulgunasekera@gmail.com  661-860-6104 A dynamic, efficient, analytical researcher with an avid interest developing expertise to create and develop a tactical role within a regulatory affairs environment. Past experience includes both clinical and laboratory research with reputed physicians and scientists. WORK EXPERIENCE California Medical Research Associates – Clinical research coordinator – May 2014 – Present  Contract with pharmaceutical sponsors to conduct clinical drug trials on patients o Sponsors include Pfizer, Amgen, Roche, Salix, Bayer, Janssen, etc.  Manage trial from implementation to completion satisfying all regulatory standards dictated by governing bodies  Collaborates and communicates cross-functionally with doctors, patients, and pharmaceutical representatives  Completes and compiles all documentation necessary to meet regulatory standards which include FDA submissions, electronic case report forms, and developing and implementing SOPs  Prepares and submits internal regulatory file applications and supporting documentation  Responsible for the daily handling and accountability of investigational products  Working knowledge of ICH Good Clinical Practice guidelines Hema-Tek Histological Svc – Surgical/histological lab technician in MOH`S micrographic surgery – January 2014 – Present  Process tissue samples from skin cancer patients using a hematoxylin and eosin stain to be viewed by a MOHS surgeon under the microscope  Use a microtome cryostat to cut histological slides, allowing rapid diagnosis in the operating room, for the surgical excision of cancer  Troubleshoot machine malfunctions  Currently working at Loma Linda Medical University with Abel Torres, MD and Andrea Smith, MD o Educate and train new medical residents and staff about MOHS procedure and methods SCHOOL EXPERIENCE Howard Hughes Medical Institute research program – 2012  Assist researcher in conducting three novel experiments headed by post docs Student Lab Assistant - 2012-2013 Laboratory of Dr. Anthony De Tomaso, Department of Molecular, Cellular, and Developmental Biology, UC Santa Barbara  Utilize microscopy and staining techniques necessary for fluorescent microscopy including Phalloidin assay, TUNEL assay on the model organism Botryllus schlosseri Immunology Lab Student – 2013  Culture a mammalian cell line from mouse thymus and spleen cells  Develop lab reports and analyze results using Microsoft Excel, ImageJ, and Guava Soft Incyte software for flow cytometry Co-founder of Immunology Club in UCSB 2012-2013  Present both personal research and relevant research articles focused on current immunology subject matter to peers and faculty LAB SKILLS Microscopy DNA Extraction Cell Culture ELISA Western Blot Sterile Technique PCR/Cloning Flow Cytometry