TMG

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Democratic Republic of Congo Research Pharmacist to Support the Randomized Controlled Trial of Ebola Therapeutics

by TMG
Jan , 31

Required Criteria:

  • BA Pharmacy professional degree and active pharmacy license in any country
  • Three years experience
  • At least conversational proficiency in both English and French
  • Must be able to relocate to Kinshasa, Democratic Republic of Congo for agreed upon period of time necessary to support the Ebola Randomized Clinical Trial
  • Must be available for occasional travel to study sites depending on needs of study, as determined by study sponsors. Country and international travel approx. 20%
  • Able to assist with logistics coordination and cold-chain of pharmacy products once in-country

Desired Skills/Experience:

  • Clinical research
    • Good Clinical Practices, in particular as they relate to pharmacy and investigational product management
    • Ethics
    • US Regulations
  • Cold-chain best practices and
  • Aseptic technique
  • Vaccines / Immunizations
  • Intravenous (IV) infusion preparation and administration

Specific Tasks Include:

Pharmacist will work in the ICC in partnership with a Congolese pharmacist as the primary pharmacist representative in-country for the US government partnership. This pharmacist will closely coordinate and operationalize plans as directed by the study sponsors and under guidance from the NIH Clinical Research Operations Manager for International Research Pharmacy Operations in order to:

  • Support pharmacy operations locally, including management of pharmacy-related inventory and receipt of shipments where applicable
  • Facilitate communications between French and English pharmacy team members
  • Ensure translation accuracy of critical pharmacy materials such as standard operating procedures and training materials. May occasional provide translations of documents when urgently needed.
  • Assist with training and continuing training reinforcement of local pharmacy staff
  • Coordinate with logistics management team to ensure appropriate tracking of orders of IP and pharmacy related material across the logistics stream to the end user at the ECTs
  • Ensure Quality Control and Quality Assurance measures are implemented for pharmacy clinical research records such as randomization records, case report forms, temperature logs, accountability logs, and product preparation worksheets
  • Evaluate and advise on execution of cold-chain procedures at drug storage locations, as well as for en-route cold-chain processes
  • Provide consultation services to investigators and medical monitors on any questions regarding investigational product information
  • Foster an environment of Quality Management through continuous learning by
    • Assisting with investigations of queries and findings at sites
    • Assist with initial and refresher training with pharmacy staff on the study protocol, standard operations procedures, pharmacy manuals, and any other relevant documents critical to the success of the study
  • Other duties as assigned

To apply

Please send your cover letter and resume to HR at michellew{at}the-mitchellgroup.com by February 8th 2019.

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