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This role is responsible for monitoring and providing oversight within the clinical trials facility as well as specific monitoring responsibilities for allocated studies. This position provides oversight for monitoring activities at the Programme as well as monitoring of clinical studies conducted by internal researchers or affiliates in other institutions.
- Research Governance manager
- Study Monitors
- Manage CTF Monitor’s budget
- Develops Monitor’s budgets
- Manage and implement monitoring activities and schedules across the Programme.
- Lead the development of monitoring strategies, budgets, guidelines, procedures, and tools.
- Review monitoring plans and reports resolve issues and establish quality assurance.
- Manage monitoring records and ensure safe keeping and ease of reference.
- Conduct training needs and competency needs assessment for monitoring team.
- Coach and mentor study monitors and additionally organise/facilitate refresher/relevant training opportunities.
- Assess monitoring needs for study protocols and develop study specific monitoring plans.
- Conduct variety of monitoring visits as per monitoring plan including site assessment, site initiation, routine visits (onsite, remote, central) & close out visits.
- Verify protocol and regulatory compliance for each study.
- Review all laboratory procedures performed regarding samples, equipment and documentation.
- Review all pharmacy procedures performed regarding supplies, shipping and dispensing records, product accountability, adequate supply and replacement and blinding and randomization processes.
- Verify the site is collecting accurate and credible data (ALCOA); and
- Assess study and site management verifying activities are properly documented and complete and accurate records.
- Bachelor’s degree in sciences (Biological, Nursing) in a relevant field; Masters is an added advantage.
- Minimum 5 Years with 3 Years’ experience at Supervisory level
- Accreditation as a Clinical Research Associate or similar certification
- Demonstrate a working knowledge of GCP guidelines;
- Demonstrate high levels of integrity and confidentiality
- Excellent interpersonal, written, presentation and communication skills
- Good analytical, problem solving and critical thinking skills.
- Teamwork and ability to work with diverse teams
- Strong Flexibility, adaptability, multi-tasking and attention to detail
- Strong team coordination and Supervisory skills.
To apply for this post you must be a registered user. Log into your account then go to Vacancies, view the post and click on the button: “Apply for this job”.
Those who had applied to the prior vacancy announcement (Number PM2632021) do not need to re-apply.
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 10 November 2021.
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).