Head, Clinical Trials Unit (CTU)

Description 

ROLE PROFILE

Job Title: Head, Clinical Trials Unit (CTU)

Reports to: Director: Institute of Global Health Equity Research (IGHER)

Location: Kigali, Rwanda, with occasional travel to Butaro, Rwanda 

Role:

The Institute of Global Health Equity Research (IGHER) at the University of Global Health Equity (UGHE) is looking to appoint Head, Clinical Trials Unit (CTU) to work on a range of clinical trial within the Institute that contributes to UGHE’s vision and mission through high-quality research and research training. As the epicenter of global health equity research and research training, IGHER generates and disseminates new and important knowledge for eliminating health inequities. It will also develop and deliver education and training that will ideally equip researchers to identify and solve problems related to health inequity.

One of the initiatives of IGHER is to establish a Clinical Trials Unit (CTU). The individual will join the collaborative research and clinical team working on various clinical research projects within IGHER. The post-holder will oversee and monitor all aspects of the conduct of the trial including the establishment of CTU, staffing and training to ensure milestones are achieved on time. The post holder will be actively participating in writing up of grant applications and study protocols. The individual will provide guidance and supervision of MBBS and MGHD students in the conduct of clinical studies.

KEY RESPONSIBILITIES 

• To lead the establishment of UGHE’s clinical trial unit at IGHER; develop annual and business plan, timelines, key deliverables and ensure trial objectives are clearly described and achievable;
• To conduct research facility readiness assessment; establishing clinical facility and research staff training needs;
• Work with partners to attract diverse clinical trials and research opportunities to the unit
• Recruit relevant clinical trials staff and faculty as required
• Organise and deliver trainings in research and clinical trials
• To lead and support clinical research including an Investigational medicinal product (IMP) clinical trials with strict monitoring and reporting requirements;
• Contribute to the development of clinical trials protocols, data collection tools, consenting procedures and co-ordinate ethics submissions;
• Ensure research reports are of high-quality and submitted on time;
• To develop SOPs/MOPs for participant recruitment, laboratory procedures, pharmacy procedures, data collection, management and overall conduct of clinical trials;
• Detect and promptly correct and report any errors in trial conduct and deviations from trial protocols as they arise;
• Ensure effective, ongoing, and regular communication between trial team members; and effectively manage the budget of the trial;
• To support the design of clinical trials research studies, including contributing to the development of case record forms, data management systems, and standard operating procedures;
• Monitor ongoing studies ensuring that the study protocols are adhered to consistently at different study sites;
• Oversee the recording and reporting of clinical adverse events, proactively anticipate and mitigate risks for all trials, and promptly liaison with study PIs;
• Liaise with independent Data Monitoring Committees, Steering Committees and other regulatory bodies related to the conduct of the study;
• Maintain excellent relations with stakeholders locally, external partners partners, donors and collaborators;
• Contribute to dissemination, in particular the publication, of research findings;
• To proactively develop new research ideas for generating future research income;
• To manage clinical research grants and promote and ensure compliance with good practice in relation to the conduct of research, the country ethics guidelines, and other relevant UGHE and donor’s policies;
• Make an effective contribution to the wider UGHE academic community including contribute to the academic life by teaching MBBS and MGHD students in clinical trials design and conduct;

QUALIFICATIONS AND EXPERIENCE

• A MBBS/MD with a special accreditation and qualification in clinical trials is mandatory. A PhD in research, especially in clinical trials is recommended.
• Experience and qualification in s, epidemiology, biostatistics, public health or global health (with a strong quantitative component) is recommended;
• At least 3 years of proven practical experience of working in clinical trials as a researcher;
• Experience of working as a clinician managing patients in a clinical environment or extensive experience of implementation and monitoring of clinical trials;
• Strong interpersonal skills, with the ability to foster collaborative relationships with colleagues and external partners;
• Proven track record of publishing original clinical research in peer-reviewed journals particularly focusing on clinical trials studies;
• Excellent communication skills with the ability to communicate effectively, both orally and in writing with meticulous attention to detail and accuracy in all aspects of work;
• Excellent time management skills and flexibility with the ability to work under pressure to meet tight timelines;
• Ability to develop ideas for new clinical trials research projects and research income generation;
• Ability to work within a multidisciplinary environment in low-resource settings;
• Ability to direct the work of a small research team and motivate others to produce a high standard of work;
• Ability to organize own work with minimal supervision; ability to work effectively, both independently and collaboratively;
• Advanced computer skills, including word-processing, spreadsheets, and G-suites