James Mathew

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.

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.

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)