James Mathew
Clinical research professional with substantial experience in pharmacy and education
About
A clinical research professional with substantial experience in pharmacy and education, currently pursuing a position in an innovative organization. Skilled in executing clinical trials in compliance with international standards and regulatory frameworks, including ICH-GCP. Proficient in the safe and efficient implementation of trial protocols, as well as in reporting and documentation.
Possesses advanced certifications in clinical research along with a robust background in pharmacy practice and academic coordination.
Experience
Clinical Research Coordinator 1 (Volunteer) - Biopharma Services Inc. - North York
(2024-10 - 2025-03)
- Coordinating conduct of the clinical trials at BPSI. Primarily the type of trails assigned will be standard Bioequivalence studies with the assistance leads clinical aspects of assigned bioequivalence trials.
- Act as the point of contact for the Clinical group for assigned trails when dealing with internal and external customers.
- Preparation of study related documents.
- Review completion of study documents (case report forms and source documents)
- Perform clinical and study procedures as per study protocols as training and experience allows.
- Detailed review of subject and study documentation, case report Forms (CRFs) and source documents.
- Ensure the conduct of Clinical trails according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, protocol and Standard Operating procedures (SOPs) always.
- Work with QA group during Audits and Audit Follow-up and in the development /revision and implementation of standard operating for the Bioequivalence trials: ensure that the SOPs are consistent with GCP, and regulatory guidelines: review and update SOPs as required.
- Responsible for remaining current with regulatory requirements (TPD, FDA, etc.).
Pharmacy Assistant - Wal-Mart Pharmacy
(2008-08 - 2024-02)
- Assist Customers with prescriptions refills, requests for over-the counter Medications and other health care products.
- Resolved customer complaints promptly in a professional manner.
- Adhered to all legal requirements relating to the safe dispensing of medications.
- Completed daily paperwork associated with filling prescriptions accurately.
- Managed inventory levels of medications and supplies
- Provided guidance on the selection of over-the-counter medications and supplements.
- Maintained inventory records by restocking shelves with pharmaceuticals.
- Received telephone calls from physicians, nurses, or other health care professionals requesting information's about medications or supplies.
- Verified accuracy of medications orders and entered data into pharmacy system.
Senior Lecturer & Course Coordinator in Pharmacy - Master skill University of Health Sciences - Malaysia
(2006-08 - 2008-01)
- Mentioned new faculty members on best practices for teaching at university level
- Conducted lectures, tutorials, seminars, workshops and laboratory class for undergraduate and graduate students.
- Maintained accurate records of student attendance and grades throughout the semester.
- Provided guidance and mentorship to junior lectures on curriculum development.
- Assisted in developing new courses based on current trends in the field study.
- Evaluated student progress through assessments such as quizzes, exams, presentations, projects and reports.
- Advised students on their professional development paths by providing resources or connections with potential employers.
- Conducted regular assessment of students performance through assignments, tests, and examinations to monitor progress and provide timely feedback.
Senior Lecturer - Devaki Amma memorial College Of Pharmacy - India
(2005-05 - 2006-08)
- Taught courses in Hospital and Clinical Pharmacy, emphasizing the integration of clinical research in pharmaceutical education.
- Advised students on their professional development paths by providing resources or connections with potential employers.
- Created syllabus outlines for each class according to departmental guidelines.
- Collaborated with other departments across campus to create interdisciplinary courses that foster creative problem-solving skills among students.
- Reviewed student assignments and examinations to assess performance levels.
Staff Pharmacist - Thengana medical mission Hospital and Research Center
(2002-01 - 2003-08)
- Compounded and dispensed medications, and managed inventory control with a focus on accuracy and regulatory compliance.
- Managed filling and dispensing of prescriptions in accordance with established polices and procedures.
- Provided medication counselling to patients on proper use, side effects and potential drug interactions.
- Assisted with inventory control processes such as ordering supplies, reconciling invoices.
Education
Post Graduate Diploma in Clinical Research - Clinical Research - Oxford College (2025-03)
Master Of Pharmacy - Pharmacy Practice - Annamalai University (2005)
Post Graduate Diploma in Hospital management - Hospital management - Annamalai University (2003)
Bachelor Of Pharmacy - Pharmacy - Rajiv Gandhi University of Health Sciences (2002)
Bachelor Of science - Science - Mahatma Gandhi University (1996)
