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Clinical Research

Toronto, Ontario, Canada
January 11, 2018

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JAIMIN VAIDYA, Contact No.: +1-437-***-****,



B. Pharm with 3 years of experience in clinical research

In-depth knowledge of clinical research procedures with their relevance to regulations and guidelines such as ICH GCP, TCPS

Profound understanding of critical aspects like protocol, informed consent procedures, various ethical aspects, source data quality and integrity as well as role of IRB.

Highly proficient in MS Office and multiple other software

Multiple certifications and awards throughout professional and academic life

Proven ability of working under stringent time frame and pressure


Ethics in clinical research

Regulations and guidelines

Standard operating procedures

Good Clinical Practice

Good Laboratory Practice

Quality management system

Protocol and ICF development

Bio-availability and Bioequivalence


Multi-tasking abilities

Meticulous approach

Creative problem solving

Good communication skills

Fast learner

Analytical mindset

Critical thinking

Administrative skills


Clinical Research Trainer (Aug-2013 to Aug-2016) Cliantha Research Ltd. Ahmedabad, Gujarat, India


Coordinated with all different departments to understand their training needs

Studied relevant regulations and guidelines and provided training to other employees

• Guidelines like Good Clinical Practice, Good Laboratory Practice, Good Clinical Laboratory Practice and other ICH guidelines as well as other requirements set forth by Health Canada, USFDA, WHO, EMEA, CDSCO, TGA and MHRA

Gained complete knowledge about various SOPs, practical execution of SOPs, repeating SOP and protocol deviations, studied relevant regulatory aspects and then provided training to ensure synchronization and continuous improvement in the functioning

• Delivered training on all various aspects of clinical research such as clinical trial activity, bioanalytical lab, quality assurance, pathology lab, medical writing, pharmacokinetic analysis and data management

Fulfilled department specific training needs such as Bioanalytical method validation, Software validation, protocol and ICF writing, SAE management, basics of statistical JAIMIN VAIDYA, Contact No.: +1-437-***-**** 2

procedure, management of Investigational product, responsibilities of Investigator and different regulatory requirements for Ethics Committee

Involved in up-gradation of system by reviewing and providing inputs in organizational SOPs

Responsible to create creative contents and assessments for training purposes

Was trained on specific aspects such as e-CTD, cold chain management and IATA regulations, ISO 15189-2012, Quality Management Systems, handling controlled drug substances, temperature mapping, Pharmacovigilance and mastering auditing skills

Relationship Executive (Oct-2012 to May-2013)

Cryobanks International India Pvt. Ltd., Ahmedabad, Gujarat, India Responsibilities

Met gynecologist regularly and discuss aspects related to stem cell banking

Identified and counseled expecting parents about stem cell banking and its advantages

Managed entire process cycle from client enrollment to the collection of umbilical cord


Received Appreciation certificate for my dedication and contribution in an annual GCP training organized at “Ahmedabad Management Association” by Cliantha Research Ltd.

Was able to learn different aspects of clinical research and gained ability to provide training to all different departments of a full service CRO in just 3 years of span which reflects my quick learning ability and ability to work hard.

While pursuing B. Pharm, I have been the founder member and the Vice-President of

“Nirma Institute of Pharmacy Students’ Association -NIPSA” consisted of more than 150 students: Year 2011-12.

o Participated in “Rural Awareness Drive” for awareness of health & hygiene at village KHANDOR-UMBRI, Gujarat, India under the banner of NIPSA. o As a part of NIPSA participated in “URBAN HEALTH DRIVE” -for awareness of health & nutrition at AHMEDABAD, India.


B. Pharm- “First class - Distinction” (from July-2008 to May-2012)

Institute of Pharmacy, Nirma University, India

Marketing Management (Post graduate certification with honors) (from Sep 2016 to Sep 2017)

Humber College -Institute of Technology and Advanced Learning, Toronto, Canada References are available upon request

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