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Clinical Trials Co-ordinator.

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Reference Number: 
CTC100118
Category: 
Clinical Healthcare and Research
Grade: 
6.01
Location: 
Kilifi, with travel( Kenya and Uganda)
Country: 
Kenya
Summary: 
JOB PURPOSE:To oversee and manage the clinical trial according to Good Clinical Practice (GCP) guidelines, regulatory requirements and institutional guidelines.

REPORTS TO:

  • Site Principal Investigator
  • Chief Principal Investigator

SUPERVISES:

  • Clinical coordinators from trial Principal Investigator teams at the 5 study sites (2 Kenya and 3 Uganda)

BUDGET AND RESOURCE RESPONSIBILITY:

  • Ordering and accountability for trial materials and consumables
  • Petty Cash

JOB DIMENSIONS:

The KEMRI-Wellcome Trust Research Programme conducts high quality clinical trials focussing on conditions that present a high burden for developing countries. The Clinical Trials Facility (CTF) oversees the design, strategy, coordination and governance of high quality phase I, II, III and IV clinical trials across Africa. The CTF is involved in both investigator-led and externally-led multicentre trials. The CTF aims to maximise opportunities for learning and training in order to maintain a cadre of highly skilled and experienced African clinical trial staff from all disciplines.

COAST trial is a multi-centre randomised controlled trial involving 4200 children which has been designed to provide the evidence for the most clinically-effective and cost-efficient targeted use of oxygen as a life-saving treatment with respect to the optimal oxygen saturation threshold for treatment and mode of delivery funded by MRC-Wellcome DfID Joint Global Health Trials. Recently a further award for COAST Nutrition (an additional nutritional randomisation) and capacity development was received from EDCTP.  The trial is being conducted in five hospitals: Kilifi County and Coast Provincial General Hospitals in Kenya and three referral hospitals in Uganda (Mulago, Mbale and Soroti). The trial and activities are anticipated to run to 2021.

The post holder will have a high level of responsibility for ensuring trial integrity, adherence to regulatory requirements, managing staff and ensuring that the trial runs smoothly. The post holder, after a period of orientation and study specific training from the current study coordinator will need to be self-sufficient and be able to work unsupervised, often with an unpredictable timescale.  The post is intellectually demanding, and involves a high level of communication among trial staff, with trial sites, study participants, regulatory bodies and the wider community.

KEY RESPONSIBILITIES:

  • Help develop, review and amend protocols, CRFs and informed consent documents as required.
  • Prepare and submit regulatory documents and obtain all relevant approvals for study initiation, continuation and amendments, and communication with regulatory bodies.
  • Develop or revise SOPs for the trial together with the study team, participate in site initiation activities and conduct training on SOPs and ensure that clinical teams fulfil their roles and responsibilities.
  • Work in collaboration with the study team and relevant departments to ensure trial preparedness and smooth execution of trial activities. 
  • Maintain the Trail Master File and participant’s files appropriately, and put in place internal systems for quality control.
  • Oversee the day to day operations related to the conduct of the trial i.e. screening of potentially eligible participants, informed consent procedures, recruitment, sampling, monitoring visits, follow up visit scheduling, quality of data and close-out monitoring visits.
  • Line management of site trial staff, including conducting performance reviews as immediate supervisor.
  • Liaise with the Community Liaison Group to develop and implement site and community engagement strategies.
  • Coordinate monitoring and audits and ensure that all requirements are met including availability of documentation and relevant staff.
  • Coordinate ordering and distribution of resources, ensuring inventories are complete and estimate long-term requirements for supplies including obtaining import permits for study drugs and export permits for samples.
  • Work with the data manager to create interim reports and presentations.
  • Participate within the CTF in scientific and business meetings.
  • Other duties that may be assigned from time to time.

QUALIFICATIONS, SKILLS & COMPETANCIES:

Essential

  • A degree in nursing or life sciences, diploma in clinical medicine, or a Registered Nurse.
  • At least three years’ experience of involvement in clinical trials including trial organisation, hands-on work in clinical trials or trials monitoring.
  • Knowledge of regulatory requirements and best practices in clinical trials
  • Strong leadership, organisational and planning ability, with an ethical standpoint
  • Strong interpersonal and communication skills (oral and written)
  • Training in GCP and research ethics
  • Computer literate with proficiency in project management tools and Microsoft applications

Desirable

  • Experience in coordinating clinical trials
  • Experience in training or teaching
  • Experience in resource management

PHYSICAL ENVIRONMENT/CONDITIONS:

  • Based at the Clinical Trials Facility in Kilifi.
  • Regular travel, including travel outside of working hours, within and out of the country to visit trial sites for site initiation, training and trouble shooting.
  • Be available to work flexibly, out of hours if necessary.
  • Exposure to patients and materials considered infectious and/or biohazardous.

APPLICATION PROCEDURE:

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".

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 24 January, 2018. 

 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).