Currently working as a Research Pharmacist at Shifa International Hospitals Limited (SIHL) (www.shifa.com.pk/scrc) a 550-bedded quaternary care hospital, attached to the Shifa College of Medicine as a teaching hospital. My job entails the following:
▪ Facilitation, day-to-day conduct, and regulation of all investigator-initiated and pharmaceutical clinical trials conducted at Shifa International Hospital from feasibility, regulatory and ethical approvals, legal review, clinical Trial Agreement (CTA), financing and budgeting, trial initiation, subject recruitment, follow-up, inspections to closeout.
▪ Maintaining close liaison with Principal Investigators, Pharmacy, and Quality Assurance departments to ensure the highest quality clinical research compliant with Good Clinical Practices (GCP).
▪ Preparing and maintaining Investigator Site Files (ISF) and Pharmacy Binders.
▪ Ensuring the Accountability of Investigational Products (IP) and Maintaining Dispensing Records. ▪ Ensuring strict compliance with International Conference of Harmonization-Good Clinical Practices (ICH-GCP) guidelines in the conduct of all clinical trials.
▪ Member DSMB that reviews data periodically to assess the safety and efficacy of the intervention.
Analyze the collected data and compare it against predetermined benchmarks, DSMB oversees these aspects to ensure that the trial is progressing smoothly and that participant safety is a top priority. Gather All trial reports monthly and present quarterly to DSMB, and take records of meeting minutes.
▪ Provided pharmaceutical care to patients by ensuring appropriate medication selection, dosing, and monitoring.
▪ Collaborated with healthcare teams to develop and implement medication therapy management plans.
▪ Gained hands-on experience in dispensing medications, counseling patients on medication use, and monitoring drug interactions.
▪ Participated in hospital rounds, contributing valuable insights regarding drug interactions and therapeutic outcomes.
▪ Assisted the pharmacy team in managing inventory, medication therapy management (MTM), and providing patient education.
▪ Regulatory submissions for clinical trials, including Dossiers, Protocol Amendments, Monthly Updates, and Close-Out Reports, to IRB, NBC & DRAP. Changes, progress, and outcomes. submissions ensure adherence to ethical standards, participant safety, and scientific integrity, fostering trust between researchers and regulatory authorities.
▪ Creating new research policies, Specifically: POLICY FOR HANDLING AND STORAGE OF INVESTIGATIONAL (STUDY) DRUGS.
▪ Mentor and train junior researchers and pharmacy staff in laboratory techniques and research methodologies.
Counselling of participants regarding study objectives.
▪ Randomization
▪ Electronic Data Capturing
▪ Weekly follow-up
▪ Maintaining site documents (ISF)
▪ Complete (e)CRFs/Assist Investigator in Solving Queries
▪ EC Correspondence & Documents Submission
▪ Assisting in sample shipment
▪ Manage IP Receipt /Storage /Temperature Monitor
▪ Perform IP Dispensing / Return / Destruction / Accountability
▪ Perform IP Instruction and IP Compliance Assessment
▪ Final reviewing and completion of the subject’s files
▪ Alignment of all the data electronically in various trackers
▪ Dairies Entering
▪ IP Shipment Receiving
▪ Maintaining IP dispensing log
▪ Maintaining IP Temperature log
▪ Maintaining IP inventory log
▪ Maintain IP destruction record
▪ Maintaining Calibration certificates related to pharmacy Equipment
▪ Maintaining Regulatory & financial documents
▪ Team lead