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TRIAL CLINICIAN - Mwanza Intervention Trials Unit (MITU)


The Mwanza Intervention Trials Unit (MITU) based at the National Institute for Medical Research campus in Mwanza, Tanzania is a collaborative research unit of the London School of Hygiene and Tropical Medicine and the National Institute for Medical Research. The mission of the Mwanza Intervention Trials Unit is to contribute to improving health through the development and evaluation of interventions against infections, cancer and other health problems by conducting research, including clinical trials, to the highest international standards. MITU aims to enhance the capacity to carry out such research in Tanzania and to contribute to the translation of research findings into health policy. The Unit is currently collaborating with other international research partners on an exciting 3 year clinical trial (the DoRIS trial) to compare the safety and immunogenicity of a one, two and three dose schedule of human papillomavirus vaccines that can prevent cervical cancer. The study will be conducted in healthy females in Mwanza city. The Unit is now inviting applications from motivated and suitably qualified candidates to fill the following position that will be based at the research laboratory of the National Institute of Medical Research (NIMR), Mwanza.

1. TRIAL CLINICIAN (1 POSITION)
The successful applicant will be a fully-registered medical practitioner (doctor), and will ideally have a post graduate qualification in epidemiology or a related field; proven technical expertise in the quality management of clinical trials related to infectious diseases and/or vaccines; experience in clinical/laboratory procedures in research and collaborative research involving human clinical, epidemiological or laboratory outcomes; proven skills and experience

Specific Responsibilities
Assist the Principal Investigators and Trial Manager with the implementation of the clinical trial in the Mwanza including:
Day-to-day management of the clinical trial site in Mwanza, Tanzania.
Dealing with clinical results and queries, reviewing case report forms, and other relevant study documentation and maintaining Study Master Files.
Participating in communication between MITU/NIMR, the London School of Hygiene & Tropical Medicine (LSHTM; the trial sponsor) and the other international trial partners.
Coordinating, training and supervising field team staff in MITU/NIMR (and other sites as required) in order to ensure that the trial is conducted to GCP and other international trial standards.
Participating in meetings and discussions to discuss research progress, findings and any other aspects of the study.
Participating in writing up of the trial findings in reports (e.g. for the TFDA) and peer-reviewed publications.
Preparation of reports for the trial governance bodies (e.g. Trial Steering Committee, Data and Safety Monitoring Board) and the funding agency.
Travel to progress and coordination meetings as required.
Undertaking other duties as may be required by the Principal Investigators of the trial and the Trial Manager.

Essential Qualifications
Candidates must be fully-registered medical doctor, with a medical degree from a recognised university.
At least one year’s relevant experience working on clinical trials, or as a research coordinator of a large epidemiological study.
Clinically active within the past 3 years and evidence of current registration to practice medicine in Tanzania.
Evidence of having practical experience in the management of research teams.
Evidence of having practical experience of assisting with leading or coordinating GCP compliant studies, including familiarity of study monitoring visits.
Evidence of having worked effectively both independently and as a member of a multidisciplinary scientific team.
Excellent inter-personal skills and a willingness to work with others to overcome problems as and when they arise.
Evidence of having worked effectively in a multicultural environment.
Excellent written and oral communication skills in English.
Ability to relocate to Mwanza to start work for MITU as soon as possible and no later than August 2016.

Desirable Qualifications
At least one year of experience working in on early phase clinical trials
Experience of working on vaccine-related research studies.
Experience of working in sub-Saharan Africa, and ideally in East Africa.
A postgraduate qualification in epidemiology or public health (or equivalent experience demonstrated through publications).

2. IMMUNOLOGY LABORATORY TECHNICIAN (1 POSITION)

The successful candidate will be responsible for processing of blood samples and performing immunology assays for the DoRIS trial.

Specific responsibilities
Performing tasks in accordance with GCP and GCLP guidelines.
Receipt and processing of human blood samples obtained from participants enrolled in clinical trials for recovery of peripheral blood mononuclear cells and subsequently performing cell counts with the use of both manual and automated techniques.
Cryopreservation of blood components.
Providing backup support to other laboratory areas including immunoassays such as ELISA.
Performing quality control of all performance techniques.
Accurate entry of sample information into the laboratory information management system and periodical maintenance of data spreadsheets.
Maintaining an inventory of sample aliquots produced and their location and the preparation of samples for transfer to the NIMR Archive.
Maintaining any documentation related to research assays and running the laboratory, such as standard operating procedures (SOPs).
Maintenance of equipment including keeping daily logs of equipment and routine cleaning of laboratory work areas.
Participation in organizing shipment of samples in accordance with the IATA guidelines.
Weekly meeting attendance and participation.
Following and ensuring strict safety procedures and safety checks.
Perform any other duties related to the DoRIS trial as may be assigned by the lab supervisor, lab manager and the principal investigators.

Essential qualifications
Bachelor’s degree in Biomedical Laboratory Technology or a related discipline.
At least one year’s work experience as an immunology technician.
Proven ability to draft and follow established SOPs.
Demonstrable ability to organize workflow efficiently.
Proficiency using MS Word, Excel and PowerPoint.
Work experience in a research laboratory setting
Experience in processing blood samples for immunological assays.
Fluent in spoken and written English

Desirable qualifications
Post graduate/advanced training in immunology.
Ability to multi-task since each clinical protocol may have unique processing requirements.
Experience working with clinical trials or research studies.
Trained in GCP and GCLP.
Previous experience working in a GCLP-compliant and/or accredited laboratory
Previous experience working in multi-disciplinary teams (e.g. with epidemiologists, clinicians)

3. SEROLOGY LABORATORY TECHNICIAN (1 POSITION)
The successful candidate will be responsible for performing serological assays such as HIV testing for the DoRIS trial, for quality assurance testing for pregnancy and for ensuring samples are stored appropriately in the MITU laboratory archive.
Specific responsibilities
Performing tasks in accordance with GCP and GCLP guidelines.
Receipt and processing of human blood samples and testing these using HIV rapid tests and ELISA for HIV and herpes simplex infections.
Receipt and testing of urine samples for pregnancy.
Cryopreservation of serum, vaginal samples and urine samples.
Providing backup support to other laboratory areas where required by the DoRIS trial team.
Performing quality control of all performance techniques.
Accurate entry of sample information into the laboratory information management system and maintenance of data spreadsheets.
Maintaining an inventory of sample aliquots produced and their location and the preparation of samples for transfer to the NIMR Archive.
Maintaining any documentation related to research assays and running the laboratory, such as standard operating procedures (SOPs).
Maintenance of equipment including keeping daily logs of equipment and routine cleaning of laboratory work areas.
Participation in organizing shipment of samples in accordance with the IATA guidelines.
Weekly meeting attendance and participation.
Following and ensuring strict safety procedures and safety checks.
Perform any other duties related to the DoRIS trial as may be assigned by the lab supervisor, lab manager and the principal investigators.

Essential qualifications
Bachelor’s degree in Biomedical Laboratory Technology or a related discipline.
At least one year’s work experience performing serological assays as a laboratory technician.
Ability to draft and follow established SOPs.
Ability to organize workflow efficiently.
Proficiency using MS Word, Excel and PowerPoint.
Work experience in a research laboratory setting especially using immunological assays.
Fluent in spoken and written English

Desirable qualifications
Post graduate/advanced training in immunology.
Ability to multi-task since each clinical protocol may have unique processing requirements.
Experience working with clinical trials or research studies.
Trained in GCP and GCLP
Previous experience working in a GCLP-compliant and/or accredited laboratory
Previous experience working in multi-disciplinary teams (e.g. with epidemiologists, clinicians)

Mode of application: All applications must be sent by email to the address below.
Letter of application addressed to Dr Severin Kabakama with details of WHICH POST you are applying for and how you meet EACH of the above criteria and your suitability for the post.
A daytime mobile telephone number and e-mail contact details.
Curriculum vitae (CV) including names and addresses of three referees (two must be from your most recent employers).
Copies of all relevant certificates and memberships and qualifications.

Closing date for applications
Applications received later than 10th July 2016 will not be considered
Interviews will be held at the earliest available opportunity and you will be notified by email if you are selected for interview.

All documents to be sent by email to recruitment@mitu.or.tz

A competitive remuneration package will be offered.

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