DENISHA KATHIRIYA

Toronto ON, M*S *L*

adsr5j@r.postjobfree.com

Cell: 437-***-****

HIGHLIGHTS OF SKILLS

● Excellent written and verbal communication, organization, and prioritization skills with the ability to set priorities and adapt to a rapidly challenging and expanding environment

● Self-motivated and driven to reach goals/objectives with limited management oversight

● Actively participated in Sponsor/CROs audits and was selected as a panel member to interview new research coordinators and research assistants

● Strong computer skills: proficient in Microsoft Office (Word, Excel, PowerPoint, and Access), Statistics (SPSS), Internet (Web applications), macOS, Windows OS and keyboarding skills with a high level of accuracy with a typing speed of 65 W.P.M.

● Highly flexible (including weekends & holidays), ability to travel to multiple sites, experienced working in a hybrid set-up or remotely

● Canadian citizen with a valid Driver’s license

● Pursuing Health Informatics at McMaster Universtiy WORK EXPERIENCE

Clinical Research Coordinator/Associate June 2021 to Present Winterlight Labs – Toronto, ON

● Study Protocols: Monitor single/multi-centre trials, Phase I-IV studies as assigned, ensure compliance and adherence with study protocols, ICH-GCP guidelines, SOPs and applicable regulatory requirements (TPD, FDA, EMEA)

● Regulatory/IRB Submissions: Generate and maintain IRB/REB documentation for internal and international regulatory agencies (Health Canada, FDA, ISO, and EU MDR, review regulatory documents during audits and ensure investigator files (ISF) are accurate, current and identical to Trial Master File, and establish company SOPs

● Study Start-up: Liaise with clinical trial and research sites globally to coordinate study start-up activities including site identification, site activations, site initiation visits, site onboardings, site training, coordinating study logistics, data collection, data monitoring, and study closeout visits according to GCP and regulatory requirements

● Site Onboarding: Conduct study initiation visits to review all study procedures and provide training to the principal investigator and site staff to ensure expectations of study are understood both in person and virtually

● Documentations & Site Training: Generate, maintain and update Clinical Operations documentation including study-specific monitoring reports, cheat sheets, checklists, and protocol-specific training materials such as training slides and videos

● Monitoring: Conduct monitoring visits to verify rights, safety and well-being of patients are protected, ensure accuracy of study data and that the study is being conducted according to the protocol, GCP and regulatory requirements

● Data Collection: Perform data collection by identifying/resolving discrepancies and open queries efficiently and accurately with the highest data quality and liaise with sponsors/CROs, sites, CRAs, study coordinators and assistants to resolve queries in a timely basis by tracking, quality checks (QC) and maintaining logs 1

● Study Closure: Conduct study closeout visits to ensure all essential documents are filed appropriately, to ensure PI and site staff understand the ongoing responsibilities and clear all relevant study materials from the site, and track and provide documents required for the shipment clearance, as required

● Recruitment & Screening: Participate in recruitment and screening of study subjects

(healthy & unhealthy participants) for internal R&D projects and academic collaborations, consent interviews, administering cognitive and/or neuropsychiatric assessments, data collection, annotation and segmentation of speech samples

● Meetings: Participate in internal team meetings and client meetings, prepare and distribute meeting minutes and maintain communication with clients to ensure they receive the project-specific updates with high accuracy, provide monitoring reports of activities and elevate site/study issues internally

● Communication is key: Maintain the communication and follow-ups with the study site personnel and study team members as appropriate with a good rapport with each throughout the conduct of the trials

● Additional/Technical Support: Main point of contact to support the Clinical Operations team, Research team, Engineering/access team to develop clinical programs, product development and database enhancements, testing and verifications and technical support to site staff on an as-needed basis

● The Team Growth: Interviewed, trained and onboarded new research coordinators, research assistants and graduate students

Clinical Research Coordinator Oct 2019 to March 2022 Scarborough General Hospital – Toronto, ON

Kent’s place – Lindsay, ON

● Identifies, analyzes, and interprets research participants and/or trial information according to protocol and SOPs, uses professional risk assessment judgment and decision-making skills to respond appropriately and proactively

● REB applications, formulating and submitting ethics reports and creation of summary reports and poster presentations for international conferences

● Individually performing clinical research activities including clinical assessments of research participants for creating source documents, screening and recruitment, obtaining consent forms and medical history, administering study questionnaires, medication assessments, symptom/adverse events monitoring, conducting follow-up visits, creating care plans for research participants, counselling and coordinating with PI, Sub Is, primary care providers, pharmacy and laboratory departments with the progress report

● Obtaining diagnostic tests and performing laboratory procedures (collection of blood, urine & stool samples), processing and shipping of samples according to IATA shipping regulations and lab manual safely and accurately, obtaining vitals such as blood pressure, respiratory rate, pulse oximetry, temperature and ECG accurately (Performing house calls as needed)

● Acts as a first of contact for research participant’s questions and concerns related to the clinical intervention being delivered in the study 2

● Collection and management of clinical data by transcribing and performing quality checks in the patient databases (EMR), data entry (REDCap, Medidata EDC & Rave, Medrio EDC, OpenClinica, Eurofins and ICON and data extraction from EPR, coding of adverse events, medical histories and concomitant disease using the MedDRA dictionary (coding) and medications using WHO drug dictionary with high quality and accuracy in a timely manner

● Interacting with Principal Investigator, Sub Is, and other departments on a frequent basis regarding initiating new research projects, implementation and interpretation of study protocols along with interacting with sponsoring agencies to answer open queries and fulfill requested resolutions in the database

● Organizing trial master file (TMF) documents according to SOPs and the current DIA model, including study documents & binders, email correspondence, training materials, and other study documents

● Performed amendments in Protocol, CRFs, and Consent forms according to recommended changes efficiently and accurately

● Reviewed literature on various aspects of study-related data with PubMed, Protein, PMC, SNP, UniGene, MedGen, clinicaltrial.ca and various other databases

● Successfully completed all mandatory pieces of training including GCP-TCPS, CRR, CAPCR, Clinicaltrials.gov along with Health Canada Inspections Division 5 Regulation

RELEVANT WORK HISTORY

Clinical Research Coordinator

Scarborough General Hospital – Toronto, ON

Kent’s place – Lindsay, ON

Oct 2019 to June 2021

Caregiver to a Parent

Rajkot– India

Feb 2019 to July 2019

Clinical Research Intern

Princess Margaret Hospital – Toronto, ON

Aug 2018 to Jan 2019

Market Research Interviewer

Numeris – Toronto, ON

Jan 2018 to May 2018

Senior Drug Safety Physician, Pharmacovigilance

Lambda Therapeutic Research Limited - India

Jan 2017 to July 2017

Medical Analyst

Medusind Solutions - India

Nov 2014 to Dec 2015

Resident Medical Officer

Sahyadri Multispeciality Hospital - India

Feb 2012 to July 2014

Internship Trainee

PDU Civil Hopsital - India

Jun 2008 to Feb 2012

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CLINICAL TRIALS

● 0000-NEU-CES-2157 Digital assessment of gait and speech in Parkinson's Disease (Regeneron PD Pilot study)

● A prospective longitudinal follow up study to assess the ability of clinical outcome assessments to track cognitive decline in Alzheimer’s disease (AD) (Novartis)

● Amsterdam DEFEAT-AD (DEFEAT-AD)

● Sunnybrook Depression/rTMS remote study (Academic collaborative study)

● CAMH Relapse Prediction SSD study (Academic collaborative study)

● A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease (Alector Al002-2)

● A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia

(Infront-AL001-2)

● A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene (Infront-AL001-3)

● A Randomized, Double-Blind, Placebo-Controlled Study of COR388 HCl in Subjects with Alzheimer’s Disease (Cortexyme-GAIN)

● A Phase 2b Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease. (Vivoryon-VIVIAD)

● A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH Study)

● A Double-Blind, Randomized, Placebo-controlled Multicenter Study to Investigate Safety and Efficacy of Elinzanetant for the treatment of Vasomotor Symptoms over 52 weeks in Post-Menopausal Women

● A Double-Blind, Randomized, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects with Moderate to Severe Vasomotor Symptoms Associated with the Menopause

(SWITCH-1)

● A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed with Osteoarthritis of the Knee (ANTIBE)

● A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection (CONSORTIUM)

● A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis (SERES-101)

● An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridium Difficile Infection (RCDI) (SERES-013)

● Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients with Metastatic Prostate Cancer (CHAARTED)

● Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial

● Healthy Bones Study: An Intervention to Improve Healthy Bone Behaviors in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) 4

● Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders with Cancer - The 5C study: A study protocol for a randomized controlled phase III trial

● Do quality of life, physical function, or the Wheatley Index at diagnosis predict 1-year mortality with Intensive chemotherapy in older acute myeloid leukemia patients?

● A prospective study examining elder–relevant outcomes in older adults with prostate cancer undergoing treatment with chemotherapy or abiraterone

(TOPCOP 1)

EDUCATION

Post-Graduate Diploma in Health Informatics Present McMaster University – Hamilton, ON

Post-Graduate Diploma in Clinical Research (Allopathy) 2017 2018 Oxford College of Arts, Business & Technology – Toronto, ON (Grade A+) Post-Graduate Diploma in Emergency Medical Services (Allopathy) 2011 2013 Symbiosis International University - Pune, India (Distinction) Bachelors of Homeopathic Medicine and Surgery 2006 2011 Saurashtra University - Rajkot, India (University first-rank holder)

(Anatomy, Physiology, Pathology, Biochemistry, Parasitology, Surgery, Gynecology, Obstetrics, Psychology and Pharmacology-Allopathy & Toxicology) (Assessed by WES with GPA 4.3) CERTIFICATES

● A Primer on Clinical Research: SOCRA (Online)

● Informed Consent for Research Part I & II: SOCRA (Online)

● Institutional Review Board Overview: SOCRA (Online)

● Good Clinical Practice (GCP/ICH): 22 March 2022

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

● Health Canada Inspections Division 5 Regulations

● Personal Risk Assessment Community – Clinic & Acute Care: Public Health Ontario

● Infection Prevention and Control/Risk Assessment & Risk of Transmission: PHO

● Behind the Statistics in Clinical Research: The University of Cape Town, Research, and Innovation (Online)

● Design and Interpretation of Clinical Trials: The Johns Hopkins University (Online)

● Data Management for Clinical Research: Vanderbilt University (Online)

● Clinical Epidemiology: Utrecht University (Online)

● Standard First Aid & CPR/AED Level C

● Certificate of Phlebotomy: 26 Oct 2021 (Renewed)

● IATA Certification: 19 Oct 2021 (Renewed)

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