About the Role
Our client, a rapidly growing pharmaceutical company, is seeking an experienced and dedicated Clinical Research Associate (CRA) to join their team based in Tembisa, Gauteng. This hybrid role offers the opportunity to be involved in critical clinical trial management, ensuring the smooth and compliant execution of studies. You will be responsible for monitoring clinical trial sites, verifying data accuracy, and ensuring adherence to protocols and regulatory guidelines. This position requires a proactive individual with excellent organizational skills and a keen eye for detail. You will work closely with investigators, site staff, and internal project teams to achieve trial objectives and contribute to the development of life‑saving medications. This is an exciting chance to advance your career in clinical research within a supportive and collaborative environment.
Key Responsibilities
- Conduct site initiation, interim, and close‑out visits in accordance with Good Clinical Practice (GCP) and study protocols.
- Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure all study‑related activities and documentation are compliant with local regulations and ICH‑GCP guidelines.
- Manage and monitor multiple clinical trial sites to ensure patient safety and data integrity.
- Communicate effectively with investigators, site staff, and study sponsors regarding trial progress and any identified issues.
- Train site personnel on study‑specific procedures, protocol requirements, and data collection.
- Prepare and present monitoring visit reports in a timely and accurate manner.
- Identify and report adverse events and serious adverse events according to protocol and regulatory requirements.
Requirements
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 3 years of experience as a Clinical Research Associate or equivalent role in the pharmaceutical industry.
- Thorough understanding of ICH‑GCP guidelines, clinical trial processes, and regulatory requirements in South Africa.
- Proven experience in monitoring clinical trial sites and managing data quality.
- Excellent communication, interpersonal, and negotiation skills.
- Strong organizational skills and the ability to manage multiple priorities effectively.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel to clinical trial sites as required (local and potentially regional).
Benefits
- Our client offers a competitive annual salary, comprehensive medical aid, and retirement benefits.
- This hybrid role provides a balance between working remotely and on‑site engagement.
- Opportunities for professional development and career advancement are available.
- You will be part of a dedicated team focused on advancing healthcare through innovative research.
- We foster a culture of respect, collaboration, and continuous learning.
- Enjoy a supportive work environment that values your contributions and promotes work‑life balance.