Clinical Trial Coordinator - Johannesburg
South Africa, Remote Job ID R0000030032 Category Project Leadership Date Posted 12/16/2024Overview
As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.
In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Collaborative
- Leadership
- Proactive
- Problem-solver
About This Role
Parexel FSP has an exciting opportunity for an experienced Clinical Trial Coodinator to join our sponsor dedicated function. The CTC is expected to work from the sponsor office in Johannesburg.
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)
Education
- B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience
- 1-2 years' experience as a minimum supporting clinical trials
- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
#LI-REMOTE
Potential Career Path
Parexel offers a growth path with diverse therapeutic areas and clients, so you can grow according to your interests.
- Associate Project Leader
- Project Leader
- Senior Project Leader
- Associate Project Director
- Project Director
- Director, Project Leadership
- Senior Director, Project Leadership
Employee Insights
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