Internal quality officer Job Vacancy at NIMR

Background:

The  National  Institute  for  Medical  Research  (NIMR)  is  a  parastatal  organization established by an Act of parliament No.  23 of 1979 (CAP. 59, R.E. 2002) and became operational  in  1980.  NIMR-Muhimbili  Research  Centre  is  one  of  the  NIMR  Centres located  in  Dar es Salaam.  The  Centre  is  currently  conducting  research  on  HIV/AIDS, Tuberculosis, non-communicable diseases (NCDs) as well as other diseases of public health importance. The Centre is looking for qualified, experienced and well-motivated personnel  to  fill  the  following  vacant  positions  whose  duty  station  will  be  in  Dar es Salaam Region.

NIMR is collaborating with the Drugs for Neglected Diseases initiative, a Swiss foundation having its registered office at 15, chemin Camille-Vidart, 1202 Geneva, Switzerland (“DNDi”); St George’s Hospital Medical School,UK; FARMOVS (Pt) Ltd,  South African; Luxembourg Institute of Health, Luxembourg and Lilongwe Medical Relief Fund Trust  – Malawi to conduct an open-label, randomized, controlled parallel-group trial to evaluate the comparative bioavailability, efficacy and safety of sustained-release flucytosine versus immediate-release flucytosine in adults with cryptococcal meningitis. The study will be conducted in two regional referral Hospital in Dar es salaam, Tanzania.

We  have  exciting  and  challenging  opportunities  for one Assistant study coordinator, one  study doctors, two research nurses, one laboratory technician and one  internal quality officer to join the NIMR research team, evaluating the impact of slow release Flucytosine. The post holders will be based in Dar es Salaam.

JOB POSITION:   Internal quality officer (1 Post)

              PROJECT TITLE: 5FC-HIV project

              REPORTING: The Project Investigator

              DUTIES AND RESPONSIBILITIES:

1. Assures adherence to all regulatory requirements by the local Ethics Committee, Tanzania Medicines and Medical Devices Authority and any other Regulatory committees on record
2. Compile and prepare materials for submission to regulatory agencies.
3. Assume a lead role for the preparation, conduct, and responses to regulatory authority.
4. Ensures that written procedures are followed and evaluates quality systems, processes, procedures, and protocols for compliance.
5. Participates in developing SOP’s, guidance documents or other tools/templates pertinent to monitoring activities.
6. Collaborates with Study Investigator and staff to identify and implement ways to improve monitoring practices, procedures, and workflows.
7. Schedules and coordinates the activities for monitoring; conduct the monitoring reviews of the trials including issuing data clarification queries as necessary.
8. Writes monitoring reports and communicates monitoring results to Principal Investigators and study team
9. Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions.
10. Work with PIs on training in Clinical Research Compliance and data management during site initiation visits and based on topics/gaps noted from monitor visits.
11. Participates in ongoing process improvement practices including problem-solving, planning and implementation of identified solutions; assists with establishing program polices or procedures to ensure efficiencies and effectiveness within the project.
12. Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
13. Prepare and assist in preparing quorterly, annual reports and quality trending reports.
14. Evaluate quality events, incidents, queries, and complaints.
15. Document internal regulatory processes.
16. Communicate any critical compliance risks noted from these activities to senior management.
17. To perform any other related duties as may be assigned by the Supervisor.

              QUALIFICATION AND COMPETENCE:

1. Medical Degree in Medicine (MD), Nursing, Pharmacy or other related field,
2. Three years medical/clinical trials experience.
3. One to two years of clinical trials monitoring
4. Registration with the professional (e.g. medical council)
5. Training in Good Clinical Practice with a valid certificate
6. Knowledge and experience in conducting randomized controlled trials is preferable.
7. Proven managerial, organizational and report-writing skills;
8. Excellent written and oral communication skills in both English and Kiswahili;
9. Experience with Microsoft Word, Excel and PowerPoint.

             TERMS OF SERVICE: One (1) year contract, which may be renewed on the basis of

performance and mutual agreement.

             DUTY STATION:

The successful candidate will be based at NIMR Muhimbili Centre in Dar es Salaam Region.

  COMPENSATION: 

A competitive salary will be offered as per project budget.

        MODE OF APPLICATION:

1. Application letters should be written in English.
2. Applicants should indicate three reputable referees with their reliable contacts.
3. Applicants must attach their detailed relevant certified copies of academic certificates including form four certificates.
4. Application letters should be attached with detailed curriculum vitae.
5. Closing date for applications is 15^th July, 2024.
6. All applications should be addressed to:

Centre Manager,

National Institute for Medical Research (NIMR), Muhimbili Centre,

Muhimbili University for Health and Allied Sciences

Off United Nation Road, Maliki Road-Upanga, Plot 1048/5

4^th Floor Haile Debas Centre for Health Professional Building (CHIPE)

P.O. Box 3436,

Dar es Salaam.