About the Role
Our client, a rapidly expanding clinical research organization specializing in cardiovascular therapies, is seeking a dedicated Clinical Research Associate (CRA) to join their team in **Cape Town, Western Cape**. This role is critical in ensuring the successful execution of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. You will be responsible for monitoring investigational sites to ensure patient safety, data integrity, and protocol compliance. This position offers an excellent opportunity to contribute to cutting-edge research in cardiovascular disease, working within a supportive and professional environment in the vibrant city of **Cape Town**. The role requires regular travel to assigned clinical trial sites.
Key Responsibilities
- Perform site selection, initiation, monitoring, and close-out visits in accordance with the clinical trial protocol and company SOPs.
- Ensure adherence to the protocol, ICH-GCP guidelines, and all applicable local regulations.
- Verify the accuracy, completeness, and consistency of clinical data through source document verification.
- Manage communication between the sponsor and investigational sites, addressing queries and resolving issues promptly.
- Train site staff on study procedures, regulatory requirements, and data collection.
- Oversee the proper handling, storage, and accountability of investigational products.
- Prepare and present monitoring visit reports, identifying and escalating any potential risks or deviations.
- Maintain organized and accurate trial documentation, ensuring essential documents are up-to-date.
- Liaise with investigators, study coordinators, and other site personnel to ensure smooth trial progress.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotechnology industry.
- Thorough understanding of ICH-GCP guidelines, clinical trial processes, and regulatory affairs.
- Proven experience in monitoring clinical trials, preferably in the cardiovascular therapeutic area.
- Excellent interpersonal, communication, and organizational skills.
- Ability to travel frequently to clinical sites within **Western Cape** and potentially other regions as required.
- Strong attention to detail and the ability to manage multiple priorities effectively.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and demonstrate initiative.
Benefits
- Our client offers a competitive remuneration package, including a performance-based bonus structure.
- Comprehensive medical and dental insurance are provided, along with a generous annual leave allowance.
- Opportunities for professional growth and career advancement are actively encouraged through ongoing training and development programs.
- Support for professional certifications and conference attendance is also available.
- Our client values work‑life balance and provides a stable and supportive work environment in beautiful **Cape Town**.
- Opportunities to work on diverse and impactful cardiovascular trials are abundant.