JUNIOR STUDY COORDINATOR
TWO (2) YEAR FIXED-TERM CONTRACT
MASIPHUMELELE: FISH HOEK
The Desmond Tutu Health Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa.
We have fantastic job opportunities across our businesses for talented people wanting to realize their full potential. Could that be you? If so, we invite you to explore the possibility of joining us to play your part in Desmond Tutu Health Foundations' exciting future.
The main purpose for this role is to implement study protocols and SOPs on site at the Masi CRS.
Minimum Requirements:
- Grade 12 with Bachelor's degree in a health related field; preferably in Nursing
- At least 1 year experience in Research Clinical environment, preferably
- At least 1 year work experience within a research environment or community-based environment
- Proficiency in MS Office (Word, Excel, PowerPoint, and Internet)
- Excellent communication (verbal & written) skills
- Ability to build interpersonal relationships and use these to manage study and site structure
- Strong administrative and logistical skills
- Strong planning and organising
- Strong Interpersonal skills
- Strong problem-solving and decision-making abilities
- Ability to work under pressure
- Ability to maintain effectiveness during changing conditions
- Detail-oriented
- Ability to work independently and as part of a team
Advantageous:
- Project management experience
- SANC registration
- Valid driver's license and own transport
- IsiXhosa speaking
- Previous experience working on clinical trials
- Good Clinical Practice (GCP) Certificate
- Knowledge of quality control, activities, systems and processes (QA/QC)
Responsibilities:
Clinical Trial Management
- The successful implementation and execution of trials and related study protocols and SOPs to ensure smooth and successful running of studies from start up to archiving
- Managing regulatory submissions
- Maintaining study site files (including Ethics communication, all versions of protocol and consent forms, staff details etc.) and documentation.
- Preparation of visit packs
- Responsible for staff training (including documentation) and oversight, data collection, and other administrative tasks.
- Awareness of study budget and line items
- Ensure that QC/ QA processes are followed
- Ensure that study specific lab and pharmacy documentation is complete
- Ensure that the site is audit and inspection ready
- Work with the monitors to resolve queries timeously
- Work with the clinical trial assistant to ensure that participant diaries are complete
- Review and update study specific SOP's
- Assist with development and updating of site QMP's
- Ensure compliance with QMP's
- SIV preparation and submissions with departments
- Set up of MTA's and vendors for translations and other requirements within the study design
- Monitoring of recruitment and ensuring recruitment and retention targets are met timeously and maintained
- Ensuring co-enrolments of different studies is managed effectively
- Troubleshooting of clinical issues for smooth clinical flow
Admin Support
- Assist community team and clinical trial assistants to draw up trackers for recruitment, retention, diary completion
- Assist PI with any presentations that need to be done on the study data
Communication
- Maintaining a positive relationship between site staff; between staff and participants and staff and any external stakeholders
- Maintenance of clear communication among all Principal Investigators (including international) and the South African-based research team, and other collaborators as needed
- Maintain a positive relationship with monitors and sponsor project managers
- Attend calls with study stakeholders
Other duties
- May have to attend calls outside of working hours to accommodate international sponsors
Values fit: Passion Innovation Progress Integrity Respect Excellence
Submit CV, motivation letter with certified copy of highest qualification and details of three (3) current contactable referees by closing date. Incomplete applications will not be considered.
Visit the DTHF Career page to view the advert (Reference number: Add) and apply: DTHF Career Page
NB: Only short-listed candidates will be contacted. We are committed to equity in our employment practices. It is our intention to appoint individuals with the aim of meeting our equity objectives. We reserve the right not to appoint if no suitable candidates are identified.
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