Clinical Research Coordinator - PAKISTAN NATIONAL JOINT REGISTRY - Remote
(2020-12)
- Coordinate all study activities/sites to ensure protocol and regulatory requirement(s) are met (e.g. data collection, data processing, PI set-up, data completion, data entry etc.)
- Protocol Training for clinical research staff
- Adverse Event Reporting and Serious Adverse Event reporting to appropriate departments(s)
- Proper Collection, handling and processing of data
- Supervise, administer and /or assist in data administration
- Maintain study files for each study and site
- Write and/or review source documents forms
- Appropriate control, inventory, storage, and record keeping of study documents
- Assist site coordinator and data officers in data management
- Write and Revise SOPs, internal procedures and ensure the accuracy of generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies
- Maintain adequate, accurate, complete and legible records.
- Provide study updates and statistic reports to management (e.g. study update, month end report, data follow up, data completion)
- Responsible for remaining current with regulatory requirements (MOH, TPD, FDA, EMEA etc.)
- Responsible to deliver training to study staff and team members
Regulatory Affairs Officer - ALGENE MEDICAL PVT LTD.
(2023-01)
- Responsible for all product development matters of company framed time to time.
- Assisted in the development and maintenance of regulatory files, records and reporting systems.
- Correspondence with DRAP for regulatory compliance
Internee - BIONCOS GLOBAL
(2020-04 - 2020-06)
- Learned about product development, product registration dossiers, DRAP website and guidelines
- Assisted in the development and maintenance of regulatory files, records and reporting systems.
Internee - WILSHIRE Laboratories
(2019-10)
- In Production, Q.A, Q.C and Warehouse Department
- R&D Department
