Infectious Diseases Institute Regulatory Affairs Assistant Jobs in Uganda

Infectious Diseases Institute Regulatory Affairs Assistant Jobs in Uganda

Key Duties and Responsibilities

Working closely with the Monitoring and Regulatory Officer (MRO) on all
communications, submissions to local and US IRBs and the Sponsors in liaison
with the study PI’s and Study Coordinators.

Assists MRO in planning and conducting training of new and old staff in research
regulatory compliance and source documentation (New/ongoing studies).

Assist the MRO in the development of the QA/QC plan and work closely with the
PI’s and CQM chief in developing the site QM plans.

Quality Control review of the study regulatory files according to Regulatory
office schedules.

Assist the MRO in monitoring the compliance of studies, submitting SAE reports
to the local IRB and to other local regulatory bodies.

In liaison with the MRO, maintain all essential documents across studies
according to GCP and Sponsor guidelines, IDI policies and advice/ guidance from
study monitors

Assist the MRO and PI during external monitoring/Audit.

Follow-up on any regulatory pending issues (submission/approvals).

Assist the MRO in reviewing of all participant’s signed informed consents once
they are delivered to Regulatory office and maintain a confidential tracking log
for all IC’s across studies.

Responsible for tracking of all research regulatory documents e.g. Staff HSP/GCP
trainings and practicing licenses.

Ensure a centralized master files filling system is in accordance with GCP
guidelines

Ensure the functionality of the Regulatory affairs system (RAIS) including
keeping it updated at all times

Assist in ensuring the functionality of Scientific review committee including
organizing or scheduling its meetings

Required Qualifications, Skills and Experience

Good Clinical Practice (GCP) and Human Subjects Protection (HSP) certificates

Bachelor’s degree in a health-related field (preferably Biomedical Sciences)

Good knowledge of national and international research ethics guidelines

Experience of working in a research setting

How to Apply;

IDI will offer a competitive remuneration package to the successful candidate.

Candidates that know that they meet the above criteria and have what it takes to excel
in the above position, please send their CVs, which should include details of email
address (if any), present position, current remuneration, Certificate/testimonials and
address of three (3) Referees plus telephone contact to the stipulated email address not
later than 30th June, 2019.(Email your application and CV to hr@idi.co.ug and let’s
save the environment).

Key Notes:

IDI is an equal opportunity employer and does not charge a recruitment fee
or any other fees at any stage of the recruitment process

Internal candidates who meet the required specifications and have worked
with IDI for a period of at least one year will be given priority.

Make sure that your application letter, CV and certificates are attached as
one document

Indicate the Vacancy Code as the subject for your email

Only shortlisted candidates will be contacted

Any form of canvassing will lead to automatic disqualification.

The Senior Human Resource Manager
Infectious Diseases Institute — IDI Knowledge Centre, Makerere University Main
Campus;

College of Health Sciences, Makerere University

P.O. Box 22418, Kampala, Uganda

For more information and job application details, see; Infectious Diseases Institute Regulatory Affairs Assistant Jobs in Uganda
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