Job Title: Regulatory Officer
Organisation: Makerere University Walter Reed Project (MUWRP)
Duty Station: Kampala, Uganda
Reports to: Head of Research and Scientific Affairs
Position Number: MUWRP-022/016
The Makerere University Walter Reed Project (MUWRP) is a non-profit HIV research program that was established in 2002 as a result of a memorandum of understanding between Makerere University and The Henry M. Jackson foundation for Advancement of Military Medicine Inc. of USA (HJF). The primary purpose of MUWRP is to develop, evaluate and provide interventions to mitigate disease threats of public health importance to Uganda. Activities include; vaccine development and building of vaccine testing capability in Uganda, conducting of epidemiological and basic research and provision of HIV Treatment, care and support in Kayunga, Mukono and Buvuma Districts.
Job Summary: The Regulatory Officer supports the expanded research program including research proposal development. The Regulatory Affairs Officer will provide and liaise with investigators and other research staff to ensure compliance with local and international regulatory and ethical guidelines/ regulations for research conducted at MUWRP.
Key Duties and Responsibilities:
· Collect and coordinate various ethical and regulatory documentation including initial submissions, continuing review reports, SAEs, protocol deviations, and close out reports.
· Work closely with ethical or regulatory body (in collaboration with the PIs) as well as initiating and maintaining pertinent correspondences.
· Maintain regulatory files/databases and chronologies in good order.
· In charge of tracking expiration of various protocol approvals at multiple ethical and regulatory bodies, drafting respective annual progress reports with timely submission as per institutional SOP.
· Work with the PI and study coordinators to maintain all essential and other regulatory documents accurately and efficiently.
· Work in close liaison with the PI and study coordinators to maintain protocol-specific source documents and CRFs, as well accurate log(s) of these.
· Developing SOPs and source documents as may be required and ensuring clinic staff are annually trained on applicable SOPs.
· Version control and tracking of all site-specific source documents and CRFs and ensuring only current IRB approved versions of protocols and informed consents (including applicable translations) are in use.
· Maintaining and tracking of research-staff CVs, GCP, HSP, SOP and protocol-specific trainings; and applicable practicing licenses as per local, international and sponsor requirements/ regulation.
· Maintain current knowledge of FDA and international regulations, standards and guidelines including GCP and ICH and keep clinical staff appraised of pertinent changes
· Coordinate monitoring and audit visits in conjunction with study coordinators
· Develop and conduct employee regulatory training
· Understanding and adhering to compliance standards as they appear in the HR policy manual, Code of Conduct, and Conflict of Interest Policy.
· Keeping abreast of pertinent international and local, clinical research guidance, regulations, and policies as they presently exist and as they are modified.
· Other duties as may be delegated by the Head of Research and Scientific Affairs.
Qualifications, Skills and Experience:
· The applicant should preferably hold a Bachelor’s degree in Nursing, Midwifery or Medicine, or Diploma in Medicine and Nursing will be considered.
· A minimum of two years of post-qualification professional experience, working in a clinical research setting.
· Current HSP and GCP certifications are a pre-requisite.
· Ability to provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy and clarity
· Proficient in scientific writing
· Ability to multi-task and meet deadlines
· Use of computers including word processing, spreadsheets, PowerPoint, email and Internet.
· Highly organized
· Ability to organize , plan and prioritize work
· Good communication skills (oral and written)
· Ability to work with a highly dynamic team
· Demonstrable understanding of the HSP and GCP guidelines and local guidelines for conducting research in human subjects as well as local approval processes for clinical trials.
· Ability to prepare and maintain essential and/or regulatory documents and study folders.
How to Apply:
All suitably qualified and interested candidates should download the application form, download here, attach it together with application letters, CVs, Photocopies of academic qualifications and three professional referees. The position number (Check top of advert) and preferred location should clearly be stated in the application letter.
Please send applications to:
The Human Resources and Administration Manager
Makerere University Walter Reed Project
Plot 42 Nakasero Road.
P.O. Box 16524 Kampala. Uganda
Deadline: 19th September 2016
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