Marie Cathrine
sydney,NS, Canada
Summary
Pharmacy professional with extensive experience in clinical trial management and pharmacovigilance. Demonstrated success in enhancing patient safety through precise documentation and effective communication. Skilled in coordinating complex research studies while promoting teamwork in dynamic environments. Dedicated to improving health outcomes and delivering exceptional customer service.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER)
Pondicherry, India
12.2019 - 06.2022
- Coordinated observational and interventional research studies (Phase I/II) focused on pulmonary tuberculosis under INDO-US TB projects funded by the NIH (USA), Warren Alpert Foundation (USA), ICMR (India), and DBT (India).
- Conducted patient-oriented research and supported research initiatives such as literature reviews, scoping reviews, and data analysis.
- Acted as liaison between sponsor, Principal Investigator, and study site to facilitate communication.
- Maintained compliance with protocols in accordance with ICH-GCP guidelines, overseeing clinical trial operations, and ensuring the appropriateness, accuracy, and completeness of trial master files.
- Medical and therapeutic review of case reports, eCRFs, and source documents, including assessment of seriousness for causality and reporting of SAEs, including root cause analysis and CAPA plan.
- Monitoring of site recruitment and participant statuses. Ensured the site readiness for inspection and regulatory audits.
- Collects and prepares documents and presentations to be approved by the Scientific Advisory Committee and the Institute Ethics Committee (IEC/IRB).
- Checks for registrations and alerts, as applicable to the trial.
- Performed logistical and administrative tasks associated with the start-up, execution, and close-out of the clinical trial.
- Coordinated with all site initiation and monitoring visits, and collaborated with project personnel and investigators to develop and complete necessary documentation for continuing renewals, annual reports, and proposal amendments.
- Served as the regulatory tracking lead for the RePORT India Consortium, which includes tracking the IRB and study amendment approvals of research sites in India and the US.
Pharmacy Assistant II
Lawtons Drugs - Continuing Care Services
Sydney, Canada
01.2024 - Current
- Prescription refill processing
- Administrative Duties: cycle counts, narcotic counts, return to stocks, TML’s, manual third parties
- Adhere to and implement all applicable company standards
- Prescription assembly - data entry, refills, compounding
- Product order receiving/inventory
- Behind-the-counter (BTC) product coordination, and management
- Filing prescriptions, ordering and replenishing supplies, cleaning
- Drug order creation and receiving using Pharmaclik
- Assist with other pharmacy operations as required
Pharmacy Assistant I
Lawtons Drugs - Continuing Care Services
Sydney, Canada
10.2022 - 12.2023
- Prescription assembly, refills, compounding
- Prepare prescription packages (Pill Pack, Unit Dose, Pacmed)
- Behind-the-counter (BTC) product coordination, and management
- Perform administrative duties (i.e. filing, supplies, delivery coordination)
- Assist with other pharmacy operations as required
Clinical Pharmacist
Sri Ramakrishna Hospital
Coimbatore, India
12.2018 - 12.2019
- Compared prescription details against safety standards to support patients.
- Educated patients on possible drug interactions, potential side effects and optimal methods of administration.
- Prepared packaging and labels for prescriptions, verifying accuracy of dosage, side effects and interactions.
- Interacted with health care professionals to support timely and proper processing of prescriptions.
- Counselled patients on new medications and OTC products.
- Educated Type 2 Diabetes Mellitus and Hypertensive patients on medication therapy, proper nutrition, and lifestyle modifications.
Education
Post Baccalaureate Diploma - Healthcare Management
Cape Breton University
Sydney, NS, Canada05.2024
Doctor of Pharmacy -
Sri Ramakrishna Institute of Paramedical Sciences
Coimbatore, TN, India12.2019
Skills
- Pharmacovigilance
- ICH-GCP
- Clinical trial management
- Documentation
- SAE reporting (CIOMS)
- Electronic Data Capture (EDC)
- Medical terminology
- Therapeutic and clinical knowledge
- Site monitoring
- MS Office
- Google Workspace
- Kroll
- REDCap
- SPSS
- EpiData
- VeevaVault TMF
- Attention to detail
- Ability to work independently
- Strong interpersonal skills
- Organizational skills
- Adaptability
- Strong communication skills
- Problem solving
- Creative thinking
- Time management
- Teamwork and relationship building
- Customer service
Certification
- Good Clinical Practices, CITI
- Health Canada Division 5, CITI
- TCPS 2: CORE 2022 (Panel on research ethics)
- CPR/AED/First-Aid, National CPR Foundation
- Professional Diploma in Clinical Research, Catalyst Clinical Services
Languages
- English, Fluent
- French, Basic
- Tamil, Fluent
Scientific Contribution
- Potential drug-drug interactions between anti-tubercular and non-tubercular drugs among patients with Pulmonary tuberculosis in Puducherry and TamilNadu, Cathrine John Marie, Senbagavalli Pb, Komala Ezhumalai, Selby Knudsen, Sonali Sarkar, European journal of Pharmaceutical and Medical Research, 2021, 8, 1, 427-440
- Study on Drug Utilization pattern of Non-Steroidal Anti-Inflammatory agents in Geriatric patients at a tertiary care teaching hospital, Chitra DB, Raju J, Jacob JL, Cathrine JM, European journal of pharmaceutical and medical research, 2019, 6, 12, 457-46
- METTL13 Mediated eEAF1A Methylation and RAS Driven Pathway in Various Cancers-A Potential Therapeutic Target, Siby E, Revanth R, Jacob JL, Cathrine JM, Chander SJU, International Journal of Pharmacy and Pharmaceutical Research, 2019, September, 16, 2, 527-541
References
References available upon request.
Timeline
Pharmacy Assistant II
Lawtons Drugs - Continuing Care Services
01.2024 - Current
Pharmacy Assistant I
Lawtons Drugs - Continuing Care Services
10.2022 - 12.2023
Clinical Research Coordinator
Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER)
12.2019 - 06.2022
Clinical Pharmacist
Sri Ramakrishna Hospital
12.2018 - 12.2019
Post Baccalaureate Diploma - Healthcare Management
Cape Breton University
Doctor of Pharmacy -
Sri Ramakrishna Institute of Paramedical Sciences
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