Research and Statistics Jobs in Kenya,Salary over Ksh80,000

259

 

Reference Number: QAO20170324

Category: Clinical Healthcare and Research

Grade: 6.01

Location: Kilifi

Country: Kenya

Summary:

OVERALL JOB PURPOSE: To work with the cross functional team at the Clinical Trials Facility to develop a comprehensive quality management system(QMS)/program that will ensure conduct of all clinical trials in compliance with approved protocols as well as local and internationally recognised regulations, policies, guidance and standards.

REPORTS TO:

Head of Clinical Research/Clinical Trials Facility

DIRECT REPORTS:

Head of Clinical Research/Clinical Trials Facility

INDIRECT REPORTS:

Research governance officer

KEY RESPONSIBILITIES:

Quality assurance

  • Develop, monitor and implement quality assurance compliance objectives and programs and report on progress/ level of compliance.
  • Develop, review, update and oversee implementation of quality standards, policies, procedures and monitoring tools.

SOPs and training

  • Coordinate development of CTF general templates, SOPs /work instructions and maintain them appropriately as well as assist trial teams in development of study specific procedures/MOPs.
  • Assist senior colleagues in mentoring and training new researchers on GCP, ethics applications and other research related issues.
  • Maintain CTF staff training database, identify and coordinate quality related training needs, develop training programs and materials and conduct relevant training.
  • Be proactive in closely monitoring changes to regulations and guidance relevant to the conduct of clinical research including clinical trial regulations, Good Clinical Practice (GCP) guidance, data protection regulations, ethical guidance and safety reporting.

Compliance and audits

  • Develop strategic audit plans, conduct audits in accordance with the plan, evaluate CAPA plans and drive CAPAs to closure in accordance with set standards and policies.
  • Identify areas of non-compliance and instigate corrective action and follow up as appropriate with support and supervision.
  • Identify and escalate critical quality issues appropriately to the Head of CTF and Research Governance office.
  • Participate in the review of clinical trials in terms of risk assessment, and assist with the construction of monitoring plans.
  • Coordinate regular QMS performance meetings to communicate objectives, discuss performance and identify areas of improvement.
  • Work with specific trial teams to identify process gaps/opportunities and implementation of continuous quality improvement initiatives.
  • Liaise with the external auditors, monitors and inspectors in conducting audit activities including scheduling audits, facilitating audits and working with relevant staff to implement actionable areas/findings.
  • Be part of the team whilst preparing staff and trial materials for inspections by other regulatory bodies, during inspection and with any follow-up actions that may be required.
  • Ensure maintenance and control of CTF QMS records and documentation.
  • And any other duties that may be assigned from time to time.

QUALIFICATIONS:

  • A BSc degree in sciences or equivalent
  • Training in quality management systems, quality assurance programs, project management or equivalent
  • At least 3 on job years’ experience
  • Experience of working in an academic or healthcare environment, or in a healthcare-related industry.
  • Current and strong working knowledge /interpretation/implementation of ICH Guidelines and other local government regulatory requirements governing clinical research.
  • Computer literacy with proficiency in Microsoft applications

COMPETENCIES:

  • Highly diplomatic, tactful and detail-oriented individual with exceptional critical reasoning and problem solving skills.
  • Flexible and adaptive approach to work.
  • Confidentiality and integrity
  • Excellent interpersonal and communication skills
  • Ability to work constructively as an individual and as part of a team in a multi-cultural environment
  • Ability to work under pressure and prioritise workload effectively.

Click here to apply

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