Clinical Research Site Leader

SUMMARY:
Are you an experienced professional in the field of Clinical Research who is deeply passionate about contributing to the South African community and committed to making a meaningful impact and taking on a leadership role?

Become part of an organisation dedicated to driving social change and take responsibility for a research site in East London, conducting clinical trials and various projects focused on community engagement, skill development, and alignment with health priorities.

POSITION INFO:
The clinical research site leader is responsible for providing administrative and operational oversight for the implementation of multiple clinical trials at the site. Key responsibilities include site management, stakeholder collaboration, staff supervision, meeting study deliverables, reporting, maintaining standard operating procedures (SOPs), and supporting team development.

KEY SUMMARY OF POSITION:

(For the sake of brevity and easy reading, only a key summary of the full job specification / job advert as provided by the client is provided below. Additional information and full details regarding the position and potential employer will be provided following our initial contact and the CV review)

PROJECT MANAGEMENT

• Lead and oversee multiple clinical studies, ensuring adherence to GCP, protocols, SOPs, and sponsor/internal standards; standardize study processes across planning, activation, recruitment, data management, and closeout phases.
• Monitor study performance, address findings from monitoring reports with PIs, maintain essential documents, provide stakeholder updates, engage with communities, and contribute to SOP development.

• Oversee daily clinic operations, including staff allocation across studies, performance evaluation, and prompt recruitment to ensure optimal site performance and resource availability.
• Act as the main point of contact for sponsors and stakeholders, and support study feasibility assessments by providing insights on site capabilities, patient demographics, and logistics.

• Supervise, mentor, and support site staff to uphold high research standards, including training based on quality and monitoring feedback.
• Promote professional development by guiding staff in scientific writing, presentations, and ongoing skill enhancement.

• Lead and contribute to scientific publications and research dissemination.
• Lead or significantly contribute to writing of grant proposals
  

• Master’s Degree in a Biomedical/Health related field (essential).
• Current registration with the Health Professions Council of South Africa, if applicable.
• Management qualification (essential).
• PhD in a Biomedical/Health related field (advantageous).
• Project Management qualification (advantageous).
• Valid GCP certification (advantageous).

• Minimum of 5 years’ experience managing clinical trials (essential).
• Minimum of 3 years demonstrated experience in clinical research site management and leading site research teams (essential).
• Comprehensive understanding of the current regulatory requirements pertaining to clinical trials (essential).
• Experience with regulatory submissions to SAHPRA, Ethics Committees, and other regulatory authorities (essential).
• Study trial document development including protocols, case report forms, and SOPS.
• Contribution to scientific publications and grant proposals.Minimum of 5 years’ experience managing clinical trials (essential).
• Minimum of 3 years demonstrated experience in clinical research site management and leading site research teams (essential).
• Comprehensive understanding of the current regulatory requirements pertaining to clinical trials (essential).
• Experience with regulatory submissions to SAHPRA, Ethics Committees, and other regulatory authorities (essential).
• Study trial document development including protocols, case report forms, and SOPS.
• Contribution to scientific publications and grant proposals.

• Proficiency in reading, speaking, and writing English.
• Proficiency in reading, speaking, and writing Xhosa (advantageous).
• Proficiency in Microsoft Office.
• Embracing and leveraging Artificial Intelligence (AI), to enhance operational efficiency.
• Willingness to work reasonable flexible hours, including weekends, if required, in accordance with the BCEA.
• Valid driver’s license (essential).