Reference Number: Pharmtech-22012019
Employment Type: Full time
Category: Clinical Healthcare and Research
Job Grade: 4.01
To carry out study related pharmacy procedures, ensure proper storage, handling, transportation and dispensing of study vaccines and/ or other pharmacy products. To conduct regular active quality assurance on documentation and vaccination procedures in line with the study protocol and standard operating procedures. The pharmaceutical technologist will assist in the conduct of studies within the KEMRI Wellcome Trust Research Programme.
- Principal Investigator
- Medical Officer
- Study Pharmacist.
BUDGET AND RESOURCE RESPONSIBILITY:
Entails working within a multi-disciplinary research team to ensure that pharmacy procedures are carried out accurately with meticulous record keeping, while strictly adhering to the study protocol. It requires a clear understanding of the study protocol and the ability to interpret and apply standard operating procedures.
- Ensure proper storage, handling, transportation and dispensing of study drugs or vaccines.
- Contribute to the development of standard operating procedures and accompanying forms to document the conditions of vaccine storage, handling, transportation and administration.
- Maintain complete and up-to-date accountability of investigational products.
- Monitor the stocks and condition of pharmacy equipment.
- Ensure timely reporting of any pharmacy related protocol deviation.
- Conduct study procedures, including vaccine constitution and correct labelling of the study products in strict adherence to the study protocol and standard operating procedures.
- Ensure that the study products are transported to the study sites in the correct packaging and temperature conditions and maintaining strict temperature logs as per the study protocol and standard operating procedures.
- Ensure safe custody of randomization information and take the necessary measures to prevent unblinding.
- Maintain strict confidentiality of study pharmacy records as per the study protocol
- Perform any other duties as may be assigned to them by the study MO or Principal Investigator or designee.
- Participate in the provision of routine pharmacy services.
- Diploma in Pharmacy Technology .
- Enrolled with the Pharmacy and Poisons Board.
- At least 2 years experience in a busy hospital pharmacy.
- Knowledge of Pharmacy law and regulations.
- Ability to work within in a team.
- Use of Windows, Microsoft Office software.
- 1-2 years’ experience in vaccine trials is desirable.
- GCP training.
- Previous experience in conducting quality assurance.
- Previous experience in ensuring cold chain management.
- Ability to work well in a team, prioritize and demonstrate the ability to set and meet objectives.
- Based at the KEMRI/Wellcome Trust office in Kilifi.
- Occasional travel to study sites.
- The post holder may be required to undertake other duties, which are broadly in line with the above key roles and responsibilities and as may be assigned by the supervisor.