About the Role
Our client, a leading global Contract Research Organization (CRO), is seeking a motivated and experienced Senior Clinical Research Associate (CRA) to join their growing team in Bloemfontein, Free State . This role is integral to the successful execution of clinical trials, ensuring data integrity, patient safety, and adherence to protocol and regulatory requirements. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities for clinical studies across various therapeutic areas. You will serve as the primary point of contact between the sponsor and investigative sites, building strong relationships and ensuring smooth trial operations. This is an excellent opportunity for a seasoned CRA looking to advance their career within a supportive and dynamic organization that is committed to advancing medical research and delivering high‑quality clinical trial services. We value professionalism and scientific excellence.
Key Responsibilities
- Perform site selection, initiation, routine monitoring, and close‑out visits in accordance with study protocols and SOPs.
- Ensure the quality, integrity, and accuracy of data recorded on Case Report Forms (CRFs) and other study documents.
- Verify that investigational product is administered and stored correctly and that study supplies are managed appropriately.
- Monitor patient safety and report Adverse Events (AEs) and Serious Adverse Events (SAEs) according to protocol and regulatory requirements.
- Build and maintain strong working relationships with investigative site staff, acting as a key liaison.
- Ensure compliance with all applicable regulatory requirements, including ICH‑GCP guidelines and local regulations.
- Identify site‑specific issues and work collaboratively with sites and internal teams to implement corrective actions.
- Prepare monitoring visit reports and follow up on action items in a timely manner.
- Participate in study team meetings and contribute to the overall success of the clinical trial.
- Provide training and mentorship to junior CRAs and site personnel as needed.
- Manage multiple clinical trial sites and associated documentation effectively.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- A minimum of 5 years of independent monitoring experience as a Clinical Research Associate.
- Thorough knowledge of ICH‑GCP guidelines, regulatory requirements, and clinical trial processes.
- Proven experience in site management, patient recruitment, and data collection.
- Excellent understanding of medical terminology and clinical trial procedures.
- Strong organizational skills with exceptional attention to detail.
- Excellent interpersonal and communication skills, with the ability to build rapport with site staff.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel to investigative sites as required (estimated 50-70% travel).
- Demonstrated ability to work independently and manage time effectively.
- Certification from a recognized professional organization (e.g., ACRP, SoCRA) is preferred.
Benefits
- Competitive salary and performance‑based incentives.
- Comprehensive health, dental, and vision insurance plans.
- Retirement savings plan with company contributions.
- Generous paid time off and holiday schedule.
- Opportunities for professional development and advanced training.
- Access to a robust network of clinical trial sites and ongoing projects in Bloemfontein .
- Company car and travel expense reimbursement.
- Supportive team environment focused on collaboration and success.