Published on: Mar 3, 2016
Transcripts - Nathan_Saralla
CLINICAL TRIAL ASSISTANT at NOVO NORDISK PHARMA (M) SDN
(+60) 0143292425 | email@example.com | 31 years old | KAJANG, Selangor
Current CLINICAL TRIAL ASSISTANT (CTA)
Novo Nordisk Pharma (M) Sdn Bhd
UNIVERSITY COLLEGE SEDAYA INTERNATIONAL
Bach Degree, Biotech (2008)
Jan 2014 - Present
(1 year 1 month )
CLINICAL TRIAL ASSISTANT
NOVO NORDISK PHARMA (M) SDN BHD | Kuala Lumpur, Malaysia
Monthly Salary MYR 3,500
Finance and Agreements
•Payment to vendors/sites within 100% of budget agreement/invoice
•Timely reporting for any deviation /increase to former budget
•Preparation of agreements within agreed timelines
•Payment processing according to Finance training and guidelines
•Agreements in CMS within SOP timelines
•Maintenance of Agreement logs
Effective Start up of Clinical trials
•All Green light documents in eTMF within timely manner after site initiation
•organizing logistics of BG meters, auxiliaries to site/affiliate within agreed timelines
Effective trial execution
•Maintenance of logs SUSAR, EC reporting, HA reporting, Shipment etc
•Ensuring calibration of thermometers within limits
•Liasing with vendors for translation, printing and photocopying and meeting organizations for projects
•Collecting of Ethics committee SOP to remain updated of new requirements for trial sites in scope
•Ensure logs of trial product shipments are within approved limits of HA
•Assist with variation submission as required for continuation of trial
•SSV, SIV, MV, SCOV reports and follow up letters uploaded to eTMF within agreed timelines
•TMF maintainence and TOC up to date at all times
•Ensure files audit ready at all times
•IMPACT quality index 90%
•Protocol/ SIIC amendments submission within agreed timelines from LTM/CRA discussion
•Adherence to all NNSOPs, GCP, local regulatory and EC requirements for clinical trials
Temperature deviation reporting
•Assisting CRA for temperature deviation reported within 1 week of occurrence when required
•temperature deviation reporting right first time 100% of time
•100% SAEs & MESIs reported within timeline
•100% SUSARs reported to BPFK within timeline
•100% safety reporting to ECs within timeline
•100% SUSARs reported to investigators within timeline
•maintanence of SUSAR tracking log at all times
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•Regular revision of ITF maintenance at site
•Regular maintenance of TMF (country & site) and eTMF
•Regular update and maintenance of details in IMPACT
Effective site closure
•Archiving of TMF within 2 months of site closeout or as agreed with ITM
•Assisting CRA with ITF archiving as and when required
Completion of Isotrain and other training requirements as organized by other departments
Ensure logistic arrangement for internal and external stakeholers e.g. CRA, CRM (when required),
/IOCMR/HQ colleagues, inspectors etc. is
performed in timely manner
Ensure Organisational effectiveness
Create storage room and stationary shelf inventory
Maintain the storage room neet and tidy at all times
Oct 2012 - Present
(2 years 4 months )
Monash University Sunway Campus Malaysia Sdn Bhd
•Assisted in preparation of research and summaries (for example, providing information and collating
data as directed by supervisor, etc),
•Prioritized and organized research activities in conjunction with supervisor.
•Independent day to day planning of research activities.
•Presented data and contributed as required in lab/ institute meetings.
•Assured responsibility for general lab maintenance (e.g, ordering, autoclaving, waste runs, lab
•Assisted in database record management and record keeping.
•Other duties as directed.
•Attended meetings and subcommittees as required.
•Attended professional development courses as required.
•Support Drug Discovery’s GLP and OSH compliance and requirements, for example, by supporting
information to relevant officers or representatives.
•Knowledge of ethical guidelines and adherence to research protocols and/or requirements and
compliance of laboratory to these standards.
Skills and Experiences
* Bachelor of Applied Science (Biotechnology) with Honours degree.
* Experience in molecular Biology.
* Demonstrated knowledge of research methodology.
* Ability to work independently.
* Excellent written and oral communication skills.
* Excellent organizational skills and activity to maintain accurate research records.
* Motivated and dedicated.
* Ability to work as part of a team.
Apr 2011 - Sep 2012
(1 year 5 months )
TECHNICAL SALES EXECUTIVE
FC BIOS SDN BHD
The duties of technical sales of life sciences are similar to those of retail sales consultants. As technical
sales personnel, I have persuaded clients to purchase products, lead price negotiations and, ultimately,
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close the sale. One major difference lies in the fact that technical sales field encourages teamwork.
Technical sales have given me an avenue to get involved and collaborate with scientists, inventors and
engineers to customize products for clients and customers. At times, I have to act as a technical sales
consultant to educate potential clients regularly to break down the complexity of the product's
components and functions. This strategy often brought new business to the forefront and requires me to
follow up via face-to-face meetings, email correspondence or online chats.
May 2007 - Jun 2010
(3 years 1 month )
UNIVERSITY PUTRA MALAYSIA
Task 1: "Screening for human Fatty Acid Amide Hydrolase Gene Mutation Associated With Drug
Bsically, I have learn to do DNA extraction, gel electrophresis for DNA quantification, PCR work,
diterminating cycle, ethanol precipitation, DNA sequencing and etc.
Task 2:" The effects of Graciliria changii on breast cancer cells"
Basically, for this experiment, I have tested on natural extract on mices which was later induced with
breast cancer. The weight and tumor size was measured with comparisan with positive and negative
controls. Finally, the mices was sacrificed and the liver, spleen and tumor lesion was harvested for
Nov 2005 - Dec 2005
(1 month )
MALAYSIAN INSTITUTE FOR NUCLEAR TECHNOLOGY
I WAS WORKING UNDER A RESEARCH PROJECT “MELECULAR BREEDING FOR NEW MUTANT
VARITIES OF ROSES". I ALSO ACTIVELY INVOLVED IN MICROPROPAGATION OF PLANT TISSUE
2008 UNIVERSITY COLLEGE SEDAYA INTERNATIONAL
Bachelor's Degree in Biotechnology | Malaysia
2002 KAJANG HIGH SCHOOL
Higher Secondary/STPM/"A" Level/Pre-U in Sciences | Malaysia
Advanced MOLECULAR BIOLOGY
Intermediate STEM CELL RESEARCH
Basic JAVA, PROTEOMICS
Proficiency level: 0 - Poor, 10 - Excellent
Language Spoken Written Relevant Certificates
Bahasa Malaysia 10 10 -
English 10 10 -
Tamil 10 5 -
Jobstreet English Language Assessment (JELA)
Date Taken 16 Mar 2011
Expected Salary MYR 5,000
Preferred Work Location Kuala Lumpur, Putrajaya, Selangor
IELTS BAND 7
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1. Ferdaos N., Nathan S., Mohd Yazid N., Karuppiah T. , Nordin N . Expression of OCT4 in Amniotic fluid stem cells derived from human
full-term pregnancy. 8th Malaysia Genetics Congress, 4-6th August 2009. Awana Genting, Pahang.
2. Norshariza Nordin , Saralla Nathan, Meng Li, John O Mason. Overexpression of WNT1 during Early and Late Stages of Neural
Differentiation of Mouse Embryonic Stem Cells (mESc). 8th Malaysia Genetics Congress, 4-6th August 2009. Awana Genting, Pahang.
3. Nordin N. , Nathan S., Li M. and Mason J. Inducible Transgene Expression in Undifferentiated Mouse Embryonic Stem Cells and
Embryoid Bodies. 2nd Malaysia Tissue Engineering & Regenerative Medicine Scientific Meeting (2nd MTERMS), 22-23 July 2008.
4. Ferdaos N., Nathan S., Nordin N. Prospective Full Term-Derived Pluripotent Amniotic Fluid Stem (AFS) Cells. 2nd Malaysia Tissue
Engineering & Regenerative Medicine Scientific Meeting (2nd MTERMS), 22-23 July 2008.
5. Nordin N., Nathan S., Li M. and Mason, J. Generating more neurons in vitro: Roles of Signaling molecules (Wnt) during neural
differentiation process of mouse embryonic stem cells. Exhibition on Research Invention and Innovation, UPM (PRPI), 29-31 July 2008.
6. Nordin N. , Nathan S., Li M. and Mason J. Stage-Dependent Activity of Wnt1 during Neural Differentiation of Mouse Embryonic Stem
Cells (mESc). Exhibition on Research Invention and Innovation, UPM (PRPI), 28-30 July 2008. Bronze medal
7. Ferdaos N., Nathan S., Mohd Yazid N., Karuppiah T. , . Prospective Pluripotent Full-term Amniotic Fluid Stem Cells). Exhibition on
Research Invention and Innovation, UPM (PRPI), 28-30 July 2008. Bronze medal
Persatuan Genetik Malaysia (PGM 0473)
Tissue Engineering Society of Malaysia (TESMA)
Malaysian Medical Relief Society (MERCY)
Woman Aid Organization (WAO)
Pameran Reka Cipta,
Penyelidikan dan Innovasi (PRPI) UPM Making More Neurons in Vitro: The Roles of Wnt Signalling During Neural Differentiation of Mouse
Embryonic Stem Cells (ES) Cells- Silver Medal Pameran Reka Cipta,
Penyelidikan dan Innovasi (PRPI) UPM Nio-Cool: Virgin Coconut Oil with therapeutic properties and its functional by product- Bronze
Training/ Seminar Attended
The Sharing of Experience and Best Practices in Publishing Articles For International Refereed Journal
Kursus Penentukuran Dan Buku Lab: Skop Penyelidikan Dan Pembangunan Kemersil
One-Day Seminar On Pediatric Neurotransmitter Diseases
2ND Malaysia Tissue Engineering & Regenerative Medicine Scientific Meeting
Translational Research in Oncology
Fume Hood Safety and Certification
Short course on Confocal Laser Scanning Microscope
Regional Advanced Course On Confocal Laser Scanning Microscopy: Live Cell Imaging
Telephone Number 014-3292425
Address 32, JALAN BUKIT MEWAH 72, TAMAN BUKIT MEWAH FASA 8, 43000 KAJANG, Selangor, Malaysia.
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