The Mwanza Intervention Trials Unit (MITU) based at the National Institute for Medical Research campus in Mwanza, Tanzania is a collaborative research unit of the London School of Hygiene and Tropical Medicine and the National Institute for Medical Research. The mission of the Mwanza Intervention Trials Unit is to contribute to improving health through the development and evaluation of interventions against HIV and other health problems by conducting research, including clinical trials, to the highest international standards; to enhance the capacity to carry out such research in Tanzania and the East African region; and to contribute to the translation of research findings into health policy.
MITU is currently collaborating with other international research partners to implement a 5 year clinical trial to test dose reductions, safety and immunogenicity of human papillomavirus (HPV) vaccines to prevent cervical cancer. The study is being conducted with approximately 900 healthy female volunteers. The Unit is now inviting applications from motivated and suitably qualified candidates to fill the position of clinical trial pharmacist. Other HPV vaccine research studies may commence in the next year.
Job Position: Pharmacist
To ensure proper preparation, handling, cold chain maintenance and storage of vaccines according to the study protocol, standard operating procedures and Good Clinical Practice.
To manage temperature monitoring and deal with temperature out of range (TOR) events.
To perform dispensing and accurate, timely accountability of study vaccines and provide reports as needed to the study investigators, sponsor, monitors or regulatory authority. (this may involve travel to study sites within Mwanza region as well as the study clinic).
To ensure that all pharmacy-related activities are implemented according to the study protocol and good clinical practice.
To ensure compliance with all aspects of pharmaco-vigilance for the clinical trial, including liaison with the regulatory authorities where required.
To prepare and update trial pharmacy manuals, standard operating procedures and tally sheets for vaccine handling, vaccine accountability and other tasks as required in conjunction with the trial sponsor, investigators and trial manager.
To ensure correct pharmacy waste disposal procedures are in place and to organise and supervise disposal of unused or expired vaccines and drugs when required.
To stocktake and ensure other medications prescribed by study clinicians for study participants are stored and dispensed appropriately.
To advise on purchase of locally available medications
To assist with procurement of pharmacy-related equipment (such as temperature monitoring equipment) and its installation.
To carry out registration tasks at the study clinic when required.
To carry out Quality Control and Quality Assurance on study procedures and documents as per the quality plan.
To assist with maintenance of the trial Investigator Site File when required.
To assist with communications relating to the health costing study.
To report to the trial manager and study investigators, work with the wider clinical trial team and attend team meetings.
To perform any other trial-related activities as may be requested by the investigators.
A degree in pharmacy from a recognized University.
At least two years practical working experience as a pharmacist.
Excellent written and oral communication skills in English.
Experience in pharmacy activities for clinical research studies.
Experience in vaccine handling, maintenance of cold chain and managing temperature excursions.
Excellent numeracy skills and attention to detail.
Computer literacy including demonstrable proficiency with Word, Excel and PowerPoint.
Willingness to work outside of normal working hours on occasions as the work demands.
Willingness to undertake other research activities within the team as required.
Substantial experience in clinical trials or other clinical research, particularly studies/trials of vaccines.
Knowledge of cervical cancer, HPV and HPV vaccines.
Previous GCP training.
Experience in applying pharmaceutical regulatory and safety requirements.
Experience of communicating or liaising with the Tanzanian regulatory authority for clinical trials.
Interested applicants should send an application letter explaining in English why they are interested in applying for this post which also indicates the earliest date they would be available to start in the role, a detailed curriculum vitae and the names of two referees by email to email@example.com by 5pm on 09th July 2021. Only shortlisted applicants will be contacted for interview.
The deadline for submitting the application is 09th July 2021.