For our Parexel Johannesburg office, we are currently looking for an experienced Clinical Trial Coordinator.
A CTC will be dedicated to a single sponsor-one of the most prestigious BioPharmaceutical Companies in the world who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. A CTC will be employed on a permanent basis, receive a highly competitive base salary combined with an excellent benefits package. They will also receive numerous financial incentives throughout the year. For dedicated Individuals we offer a career path within Parexel, world-class trainings and professional challenges. At the same time, we offer a healthy work-life balance valuing our employees’ welfare just as highly as that of our Patients.
In this role you will be supporting the Study Manager and wider study teams from start up to close out.
Job Responsibilities
Trial and site administration:
- Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non‐clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request
Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents
- Assist with electronic Trial Master File (eTMF) reconciliation
- Updating manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Execute eTMF Quality Control Plan
- Obtain translations of documents
Regulatory & Site Start Up responsibilities:
- Provide and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions
- Publish study results for Global Clinical Trial Operations and Regulatory Affairs where required per local legislation
Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
- Development of country and site budgets (including Split site budget)
- Tracking and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval, and maintenance
- Updating and maintenance of contract templates (in cooperation with Legal Department)
We expect the applicants to hold a Bachelor’s degree in life science and have experience supporting clinical trials.
Our Talent Acquisition Team can answer any additional questions about the role or Parexel.
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