About

I am a Research Pharmacist with more than 7 years progressive experience in the conduct of clinical trials. I am trained in pharmacy, medicinal chemistry, and clinical research. As a member of the senior clinical management team I participate in strategic and operational decision making involving clinical trial selection, protocol development, institution review boards (IRBs) submission, protocol planning and progress review, monitoring and close out activities. I am also a reviewer with the Kenya Medical Research Institute (KEMRI) center for clinical research where I review protocols and other clinical trial related documents. My key competencies include investigational products supply chain management, implementation of International Conference on Harmonization (ICH), Good clinical practices (GCP) and Human Subject Protection (HSP) guidelines, regulations and policies, formulation and implementation of general and study specific procedures (SOPs), pharmacy quality control/quality assurance plans and pharmacy establishment plans in line with local and international regulatory requirements. As Pharmacist of Record (POR), I organize, facilitate and train clinic research staff on all general and protocol-specific procedures, and handle the day-to-day pharmacy operations. I am also the liaison officer between National Institute of Health (NIH) Division of AIDS (DAIDS) Pharmaceutical Affairs Branch (PAB) and the site on all issues regarding IP management.

Skills

  • Strategic Planning
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Experience

Faith Riziki

Work experience
  • Key Responsibilities;
  • Coordination of all research pharmacy operation and perform the day-to-day pharmacy activities including investigational product preparation and dispensing.
  • Supply chain management of Investigation products and Investigation New Drug (IND) including shipment handling both locally and internationally.
  • Liaison contact between the site and DAIDS PAB on all issued related to pharmacy operations and practices.
  • Quality Management-Development and implementation of Quality Control and Quality Assurance plan, and Pharmacy establishment plans (PEP) for ACTG, IMPAACT, HIV vaccine trials network (HVTN), Military HIV Research Program (MHRP) and industry-based stand-alone protocols.
  • Supervision and training of pharmacy and other clinic research staff on all protocol related and general standard operating procedures related to the pharmacy operations
  • Part of the clinic management team tasked with day to day running and operations of the clinical research site (CRS)
  • Key Achievements;
  • Streamlined investigational products importation and clearance process that led to a reduction in lead time by 50%
  • Implemented a storage plan that significantly reduced pharmacy dispensing errors

Faith Riziki

Work experience
  • September, 2014 - September, 2015
  • Fulltime
  • Key Responsibilities;
  • Clinical research participant care- medication dispensing, adherence counseling, monitoring of progress and medication response, including adverse events and their management.
  • Facilitating study drugs importation -Application of import permits, and follow up on clearing of drugs at customs.
  • Temperature monitoring and documentation for all pharmacy storage areas (lockers, fridges and freezers both in pharmacy and freezer farm.) to preserve the integrity, stability, and effectiveness of study products for each protocol.
  • Study product control which includes ordering, receiving, storage, accountability, inventory, dispensing, drug returns, and drug destruction.
  • Pharmacy related protocol document retention, archiving, and destruction according to the laid down procedures by DAIDS and other non network sponsors.
  • Key Achievement;
  • Implemented movement of closed out protocols to a permanent archive thereby creating about 70% free storage space in the pharmacy for incoming protocols and drugs that needed room temperature storage.

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