- The pharmacist ensures timely and efficient provision of all pharmacy services at the KEMRI-Wellcome Trust Research Programme (clinical services and clinical trials). They will contribute to health research, clinical services and the academic endeavours of the programme by providing pharmaceutical services and technical assistance.
- They will be the focal person for matters relating to the quality, regulation and supply of investigational products.
- They will ensure compliance with the protocol, pharmacy law, national standards, regulations, and Good Practices.
REPORTS DIRECTLY TO:
- Head of Clinical Services
INDIRECTLY REPORTS TO:
- Head of Clinical Trials.
BUDGET AND RESOURCE RESPONSIBILITY:
This is a mid-level management position, and entails working with multiple projects. The job-holder will work closely with investigators, health professionals, research co-ordinators, sponsors, monitors, the Pharmacy and Poisons’ Board and National Quality Control Laboratory. It requires a clear understanding of clinical research methodology, pharmacy regulations; and the ability to use professional skill and judgement to resolve problems.
- Assume professional responsibility for all pharmacy services offered at the research site.
- Participate in protocol development, protocol submission, manuscript writing and review.
- Train and supervise pharmaceutical technologists and dispensers and unblinded research staff involved in Investigational Product(IP) handling.
- Contribute to the development of standard operating procedures and a quality system for all pharmacy procedures.
- Apply for import and export permits.
- Apply for drug testing at the NQCL.
- Apply for authorisation to destroy unwanted pharmaceuticals.
- Supervise contract manufacturing of IPs.
- Assist with applications for IP shelf-life extension.
- Offer QA oversight for drug manufacture, repacking and relabelling.
- Plan, supervise and document destruction of IPs.
- Participate in site monitoring visits, audits and inspections.
- Develop product specifications.
- Supervise shipment logistics, receipt, verification, storage, handling, and transportation of all clinical supplies.
- Maintain complete and current study related documentation & pharmacy records and support protocol compliance by all staff.
- Ensure that all pharmacy equipment is validated and in good working condition.
- Ensure timely reporting of any pharmacy related protocol deviation.
- Conduct study procedures, including drug manufacturing, repacking, relabelling, vaccine re-constitution and correct labelling of the study products.
- Quarantine expired/deteriorated products and refrigerated products exposed to temperature excursions.
- Restrict access to investigational products and participant randomization information.
- Participate in the provision of routine clinical services.
- Perform any other research, pharmacy, clinical or administrative responsibility as delegated or required.
- A Bachelor’s Degree in Pharmacy.
- Current registration with Kenya Pharmacy and Poisons Board
- At least two years’ experience working in a busy hospital pharmacy at a managerial level
- Knowledge of pharmacy law, pharmaceutical quality assurance and national guidelines on the conduct of clinical trials.
- Training in ICH-GCP
- Previous experience in clinical research or trials.
- Knowledge of Microsoft Office software, pharmacy computer applications and the internet.
- Ability to work well in a team, prioritize tasks and solve problems.
- A post-graduate qualification in pharmacy, public health, epidemiology or management.
- Research Ethics training.
- Based within the KEMRI/Wellcome Trust Research Programme.
- Occasional travel to study sites.
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All applicants are required to state their current/last salary.
Candidates must supply an email and telephone contact that will be used when offering interviews. Only shortlisted candidates will be contacted. Shortlisted candidates shall be required to produce ORIGINALS of their National Identity Card, academic and professional certificates, original transcripts and testimonials, detailed curriculum vitae and valid clearance certificate (certificate of good conduct) during the interviews.
The application closing date is 29 March, 2019.
KEMRI-Wellcome Trust Research Programme (KWTRP) is an equal opportunity employer. Direct or indirect canvassing will lead to automatic disqualification. KWTRP does not charge a fee at any stage of the recruitment process (application, interview, meeting, processing, training or any other fees).