Clinical Trial Specialist

4 days ago


Pretoria, Gauteng, South Africa PSI CRO Full time
Job Summary
We are seeking a highly skilled Clinical Trial Specialist to join our team. The ideal candidate will have a strong understanding of clinical trial management and be able to effectively communicate with investigative sites.

Responsibilities:
  • Maintain and generate relations with Investigative Sites.
  • Maintain and refine internal site databases in cooperation with Study Startup, Clinical Operations and Process Improvement.
  • Participate in the development of improvement strategies for the site identification process, implementation thereof, as well as related training activities.

Key Responsibilities:
Define the main study objectives and the optimal site profile. Create initial list of potential sites. Communicate with project teams on project/ regional level to fine-tune strategy and methodology of initial and follow-up site contacts depending on indication, regional specifics, and technologies in use. In cooperation with the project team, maintain a study site identification tracker for further site evaluation and selection activities. Liaise with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives. Perform due diligence check of regulatory and legal limitations applicable to the recommended investigators or clinical sites. Participate in project team meetings during study startup, as needed. Support the project team throughout study startup and further on, whenever additional rounds of site identification are necessary, and/or additional information on the site/investigator is needed.

Requirements:
University/college degree (Life Sciences/Pharmacy/RN/Healthcare field is a plus), or an equivalent combination of education, training and experience. Minimum 10 years of proven prior experience in Site Identification/Feasibility/Study Start-Up activities/Site Monitoring. Understanding of Good Clinical Practice, local laws and applicable regulations in the region. Full working proficiency in English. Communication and collaboration skills. Demonstrated ability to work in a dynamic environment, under compressed deadlines across several projects, each with unique requirements.

About Us
We are a global company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. We bring together passionate individuals who work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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