Joint Clinical Research Centre Clinical Trial manager Jobs in Uganda
Joint Clinical Research Centre Clinical Trial manager Jobs in Uganda
Overall Purpose of the Role To be part of a dynamic team leading the first African trial of a revolutionary new approach to HIV treatment – treatment by injections once every two months.
The post holder will be the main contact person for the 7 trial sites in 3 African countries and will be responsible for day-to-day oversight of the trial across all trial sites.
For the right candidate this post represents a unique opportunity to learn valuable international trial coordination skills and to play an exciting part in the future direction of HIV treatment in Africa.
Key responsibilities
The post holder will be responsible for the following:
Coordination
Collaborating with Project Manager to set targets for study sites and contracted organisations for study implementation
Coordinating site management activities.
Coordinating and supervising clinical monitoring team(s)
Arranging and overseeing site visits
Periodic checks / reminders to sites on stocks of essential consumables
Advising / assisting sites with procurement of consumables
Pharmacy supply chain management support: serve as primary liaison for site pharmacists
Quality assurance /quality control (QA/QC)
Support generation and maintenance of key documents and materials for the Quality Assurance /Quality Control Manual. These include but not exclusively SOPs, Pharmacy plan and monitoring plan
Assuring compliance with SOPs, local regulations, and CFR, ICH and GCP guidelines
To prospectively identify clinical trial quality /performance risk factors, determine potential impact and address them with study coordinating centre team
To support backup Site Monitoring Visits (SMVs) and writing SMV reports
Safety reporting
Organising SAE review and onward expedited and periodic reporting to appropriate competent authorities and stakeholders including pharmaceutical companies
Liaising with the Coordinating Centre Clinical Reviewer(s) for verification of clinical content of SAEs
Tracking and documentation of SAEs progress until resolution for
all sites
Preparation of annual summary of adverse events for ethics committees
Sample/laboratory oversight
Oversee and document batched sample shipping to central repository
Provide administrative coordination for shipments from sites to central lab repository in accordance with local and international requirements for biological specimen transport
Reviewing specimen shipping logs
Track storage documentation/ volume / freezer capacity at the central repository
Liaise with sites to ensure sample shipment timelines meet SOP / protocol requirements
Troubleshoot challenges along the specimen journeys with appropriate study staff
Liaise with central lab repository to ensure turn-around-time (TAT) for real time reporting of protocol-covered test results meet SOP requirements
Corporate/Local Responsibilities & Requirements:
The job holder must at all times carry out their responsibilities with due regard to the policies of JCRC:
Requirements
Essential
Desirable
Education/Qualifications / Training
Bachelors in nursing or life sciences
Or Diploma in clinical medicine from a recognized institution
Qualification in management
Clinical trials training
Previous work experience
At least three years experience in HIV research
Experience using and clear understanding of Electronic Data Capture (EDC).
Clinical trials research
Technical knowledge
Proficient with Microsoft Office Word and Excel.
Outstanding communication skills, both verbal and written.
Other
Available to travel.
Ability to work independently and prioritize duties.
How to Apply:
Apply to: The Manager Human Resources & Development
Email: hr@jcrc.org.ug
Deadline: 11th December 2020 at 5:00 PM
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