Organization: Baylor
College of Medicine Children’s Foundation
College of Medicine Children’s Foundation
Duty Station: Kampala,
Uganda
Uganda
Report to: Regulatory
Affairs Coordinator
Affairs Coordinator
About US:
Baylor College of Medicine
Children’s Foundation – Uganda (Baylor -Uganda) is a private not for profit NGO
that provides: HIV/AIDS care, treatment and prevention services; maternal child
health services; Health Professional training and Clinical Research.
Children’s Foundation – Uganda (Baylor -Uganda) is a private not for profit NGO
that provides: HIV/AIDS care, treatment and prevention services; maternal child
health services; Health Professional training and Clinical Research.
Key Duties and Responsibilities:
- The
Administrative Assistant – Regulatory Affairs will review submission
packages and facilitate submission to Ethical and regulatory bodies - Develop
and maintain tracking system to assess progress on submission - Maintain
up-to-date regulatory binders - Develop
Standard Operating Procedures that streamline regulatory procedures - The
jobholder will correspond with Ethical and Regulatory bodies - Ensure
timely renewal of practicing license and registration certificates of
researchers - Ensure
proper filing of study documents in properly labelled files while tracking
documents coming and leaving the office - Send
feedback to project leaders, about all documentation, submissions and
communication - Tasked
with archiving of completed studies documents - Ensure
payments are made to regulatory authorities in a timely manner - Ensures
that all study procedures and reporting are conducted - Ensures
that all source documents are appropriately stored and maintained - Serves
as the primary liaison between the CRS, investigators, sponsor, IRBs, and
other regulatory bodies for all regulatory-related matters - Ensures
that all SOP, protocol, and regulatory mandated timelines and IRB reviews
are followed - Actively
participates in internal, regulatory, and NIH compliance audits - Provides
training for regulatory and protocol related policies to study staff - Completes
forms/ source documents.
Qualifications, Skills and Experience:
- The
ideal candidate for the Baylor Uganda Administrative Assistant –
Regulatory Affairs job opportunity should hold a Bachelor’s Degree in
Nursing or Degree in Public Health, Public Administration & Management
or Office Management , Bachelor of Administration or any related Degree. - The
candidate must have previous research experience in managing regulatory
documents & short courses on research methods. - Administrative
Capacity working on clinical research projects & GCP training are
added advantages. - Broad
knowledge of ICHGCP, Clinical Research Regulations
How to Apply:
All suitably qualified and
interested candidates should send their applications to the address below
including a detailed CV demonstrating possession of the job requirements,
current position, names and addresses of three referees i.e. email and phone
addresses, copies of professional/academic documents, email address, and day
time telephone contact. The applicant must have at most a credit 6 in Math and English.
interested candidates should send their applications to the address below
including a detailed CV demonstrating possession of the job requirements,
current position, names and addresses of three referees i.e. email and phone
addresses, copies of professional/academic documents, email address, and day
time telephone contact. The applicant must have at most a credit 6 in Math and English.
Send applications via E-mail
to: [email protected].
to: [email protected].
The Human Resources Manager,
Baylor College of Medicine
Children’s Foundation-Uganda,
Children’s Foundation-Uganda,
Block 5 Mulago Hospital,
P.O. Box 72052, Clock Tower,
Kampala. Uganda
Kampala. Uganda
Deadline: 17th January 2018
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