Senior Clinical Research Associate

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Conduct site qualification, initiation, monitoring, and close-out visits for assigned studies.

• Assume full responsibility for investigator sites, ensuring effective management in accordance with the Clinical Monitoring Plan (CMP) and study requirements.

• Ensure compliance of investigator sites with study protocols, ICH GCP, SOPs, and relevant regulatory standards.

• Develop and sustain strong, long-term relationships with investigators and site personnel, providing continuous training and support.

• Assist in study start-up activities, including the collection of essential documents, regulatory submissions, and interactions with Ethics Committees.

• Identify risks at the site level and implement corrective and preventive measures to guarantee study quality and timelines.

• Collaborate with cross-functional teams to support study delivery, including discussions on budget/contract and the development of informed consent.

⛳️ Requirements

• A degree in life sciences or a related field.

• At least 5 years of experience in clinical monitoring and investigator site management within a CRO or pharmaceutical setting.

• Strong understanding of ICH GCP as well as local and international regulatory requirements.

• Experience throughout the entire trial lifecycle, including start-up, monitoring, and close-out activities.

• Willingness and capability to travel up to 60%, possess a valid driver’s license, and be based in Johannesburg.

• Experience in diabetes, cardiology, or obesity is a plus.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.