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Clinical Research Assistant/Coordinator

Toronto, Ontario, Canada
October 15, 2018

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Denisha Kathiriya



To become a qualified Clinical Research Coordinator and have the opportunity to join a progressive success oriented research team that acknowledges and encourages employee accomplishment and advancement. I am capable of applying clinical research regulatory requirements such as GCPs and ICH guidelines. I am apparently conscious of the diversity and aware of broadly ranged patient needs and situations. HIGHLIGHT OF SKILLS

● Excellent problem solving skills,

● Experience working with a multidisciplinary team in a healthcare setting

● Excellent written and verbal communication skills, excellent organization, prioritization skills,

● Ability to learn quickly and work independently, Ability to work under pressure and attention to detail in fast-paced environments, Ability to perform multiple concurrent tasks

● Able to lead and motivate staff, able to take any challenge with an objective to succeed

● Ability to thrive and adapt in a rapidly challenging and expanding environment, Punctual and exhibits excellent work ethic

● Computer knowledge-Proficient in Microsoft Office (Word, Excel, PowerPoint, Access), Internet and Windows Operating System, Intermediate computer & keyboarding skills, with a high level of accuracy

● Typing speed 58 W.P.M. with accuracy

● Multilingual: English, Hindi, Urdu, Marathi and Gujarati

● Valid Driver’s Licence (Ability to travel to different hospitals/clinics) CORE COMPETENCIES

● Extensive knowledge of medical terminology

● Knowledgeable with Investigator’s brochure, Informed consent form (ICFs), and standard operating procedures (SOPs)

● Certified in Standard First Aid and CPR (Level C)

● TCPS-2 (Tri-Council Policy Statement 2)

● Knowledge of research regulations and guidelines, such as ICH/GCP guidelines

● Declaration of Helsinki and FDA CFR and Health Canada TPD

● Knowledge of IATA shipping regulations

● Ability to enter data fast and accurate, including open-ended questions. Extensive knowledge of various softwares like REDcap and Access etc.

● Enthusiastic & able to maintain engagement throughout phone interviews

● Strong understanding of computers with CATI (Computer Assisted Telephone Interviewing) Program.


Clinical Research Intern Present

Princess Margaret Hospital (Prince Margaret Cancer Centre-UHN) Post-Graduate Diploma in Clinical Research 2017-2018 Oxford College of Arts, Business & Technology – Scarborough, ON Post-Graduate Diploma in Emergency Medical Services 2013 Symbiosis International University - Pune, India

Bachelors of Homoeopathic Medicine and Surgery 2012 Saurashtra University - Rajkot, India


Clinical Research Intern

Princess Margaret Hospital – Toronto, ON Aug 2018 to Present

● Interact with patients and physicians in collecting data and medical charts for clinical studies

● Responsible for screening and review of health chart for screening, recruitment of study subjects, conducting follow-up visits and end of visits with study participants

● Approach for study to a patient and obtain proper written informed consent from each study participant prior to participation in the study

● Counselling with the patient regarding their follow-up visits, to obtain study related questionnaire and study related questions

● Conducting qualitative surveys and interviews and analyzing the data

● Formulate and submit ethics reports, study consents, and patient questionnaires - input and management of clinical data by performing quality checks (QCs), work with Microsoft Excel, Access, Powerpoint and Word and patient databases (EPR) - assist in sample tracking and sample collections

● Clinical data entry into databases and data extraction from patient database into CRFs with high quality and accuracy with minimum error

● Execute study-related and CGC related administrative tasks - work under the direction of Senior Clinical Research Coordinator, including Principal Investigator

● Coordinate and schedule patient visits as per study protocol, maintain patient visits in a calendar with updates and schedule patients appointments

● Perform and submission of amendments in Protocol, CRFs, Consent forms according to recommended changes from PI

● Literature search about various aspects of study related data with PubMed, Protein, PMC, SNP, UniGene, MedGen and, and various other databases.

● To perform delegated protocol specific activities completely and accurately Market Research Interviewer (part-time)

Numeris – Toronto, ON Jan 2018 to April


● Conducting surveys via telephone using persuasive communication skills to encourage participation in Numeris' ratings research

● Knowledge of the medical device industry and Market Research methodologies

● Multi-tasking skills, adherence to firm targets

● Performed audits for data entered

● Data entry with high accuracy and efficiency

● Reliable attendance for scheduled shifts

● The ability to follow outlines of the survey

● Always remain neutral on their opinions, to avoid collecting any skewed or biased data.

● Report any technical problems to the team leaders to avoid losing respondents.

● Making outbound calls to our clients regarding research on Politics, Healthcare, Economics, TTC, Internet, Television, Radio, Mobile, Customer-satisfaction, and many more.

● Trained on various projects with different skill-sets of different subjects and collaborate with quantitative and qualitative research projects Customer Service Representative

Teleperformance - Scarborough, ON July 2017 to Nov 2017

• Provided excellent customer service at all times with customers on inbound calls & when required to call the customer back.

• Followed up to customer inquiries by taking specific action in a timely manner

• Familiar with phone apps and downloading

• Provided assistance to customers regarding their queries related to product

• Solved problem to help customers resolve issues on the first call, Instructed, explained and provided solutions to customers regarding their products

• Provided Inside Sales and Upsells to existing customers

• Entered data from customers into various software programs

• Appropriately communicated with upset customers to resolve their inquiries and issues regarding orders

• Promoted and offered products and services by consulting, gathering information, and evaluating customer needs

• Thrived as a team player in a fast-paced, high-energy, change-oriented environment

• Participated in additional training courses when needed and successfully completed training as per requirement of project and campaign

• Performed other related duties and assignments as required and as assigned by supervisor or manager

Senior Executive-Medical Reviewer Jan 2017 – May 2017 Lambda Therapeutic Research Limited - Ahmedabad, India

● The medically assessed safety profile of the client’s product range, evaluated adverse events and provided causality

● Reviewed data entry, drug coding, MedDRA coding and listedness

● Assessed expediting and reviewed narrative of ICSR in accordance with Company’s controlled documents (e.g. SOPs, WIs, Guide) along with relevant regulations and guidelines

● Reviewed literature for selection of ICSR and article of interest (for signal detection and aggregate reports)

● Performed signal detection for client’s medicinal product and assessed benefit risk balance of the client’s medicinal product

● Prepared, revised, reviewed SOPs, Wls, templates, guides and guidance training documents

● Communicated urgent safety issues to Line manager and QPPV

● Ensured compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements and timely submission of ICSR

● Worked with the Medical review team leader/Aggregate Report/ ICSR team leader to escalate issues or tasks outside the normal scope of work

● Provided backup medical support on products/projects where required

● Gained knowledge of local and national requirements for Pharmacovigilance requirements

● Interacted with staff at various levels and in various functional areas to resolve any issues that came up during reviews

● Provided input into responses to inquiries from regulatory authorities or health care professionals on safety issues

Medical Analyst Nov 2014 – Dec 2015

Medusind Solutions - Ahmedabad, India

● Prepared medical report summarization as per the patient’s documentation containing medical data/information

● Communicated daily with physicians on the call regarding report generation, new updates and live portal changes

● Searched for the correct patient in the database (EHR-EMR) or as per hospital system

● Browsed the correct citations/guidelines and rationale in relation to request given for treatment

● Ensured resolution of all prospective and current patients’ inquiries in a timely manner and according to standard guidelines

● Segregated medical documentation and prepared the medical summary

● Prepared the final reports as per the given treatment request according to treatment guidelines and medical laws of a particular province

● Prepared the audited report with certification, partial-certification, and/or non-certification of a given treatment request

● Conducted training sessions for new employees

● Awarded as a Bright spark winner and Mountain mover 2 times Resident Medical Officer

Sahyadri Multispeciality Hospital - Pune, India Dec-2013 – Jun-2014 MJM Multispecialty Hospital - Pune, India Aug-2012 – July-2013

Ashirwad Multispeciality Hospital - Rajkot, India Jun-2011 – Feb-2012

Ratnam Multispeciality Hospital - Rajkot, India June-2008 – May-2010

● Examined patients and edited their histories, ordered laboratory tests, X-rays and other diagnostic procedures and consulted with other medical practitioners to evaluate the patient’s physical and mental health

● Prescribed and administered medications and treatments, performed and assisted in routine surgery, provided emergency care, provided acute care management, vaccinated patients and provided prenatal and postnatal care

● Assisted routine and emergency admissions in ICU, ICCU, NICU, & PICU along with resuscitation of patients and stabilization of all emergency cases

● Prepared documentation of treatment charts, diagnostics, transfusions, consent reports, lab tests, and MLC forms

● Reviewed medical charts and reported all details about treatment in case files

● Prepared discharge reports with a detailed summary of the hospitalized patient

● Advised patients and their families on health care including health promotion, disease, illness and accident prevention

● Provided counselling and supported patients and their families on a wide range of health and lifestyle issues

● Coordinated and managed primary patient care

● Reported births, deaths, and contagious and other diseases to governmental authorities Workshops

Basic Life Support (BLS) & Advanced Cardiovascular Life Support (ACLS) Oral and Practical presentation by Intensivist, India 2014

Emergency Medical Services: Seminar conducted through an oral and practical presentation by Review of Paramedics, India 2013

Seminar on Cardiac Emergency, the Audio-visual presentation on Cardiology including various emergency case scenarios, as well as causative factors, India 2012 Seminar on Homoeopathic case studies, Concept of Materia medical and Organon of medicine elaborated by Dr. Praful Vijaykar India 2011

References Available Upon Request

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