About the Role
Our client, a prominent pharmaceutical research organization, is seeking a dedicated and experienced Clinical Research Associate (CRA) to oversee clinical trials in and around the Richards Bay, KwaZulu-Natal. This role is essential for ensuring the integrity, quality, and compliance of clinical trial data and activities conducted at investigational sites. The CRA will be responsible for site selection, initiation, monitoring, and close-out, ensuring adherence to Good Clinical Practice (GCP) guidelines, study protocols, and regulatory requirements. We are looking for a proactive individual with excellent communication and interpersonal skills, capable of building strong relationships with investigators and site staff. This is a field-based position, offering the opportunity to travel and contribute significantly to the development of life-saving medications. Our client prides itself on fostering a culture of excellence and scientific rigor within the Richards Bay, KwaZulu-Natal region and beyond. Join us in advancing medical science.
Key Responsibilities
- Conduct pre-study visits, site selection, initiation visits, routine monitoring visits, and close-out visits for clinical trial sites.
- Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
- Ensure adherence to the study protocol, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements.
- Train and support investigators and site staff on study procedures, protocol requirements, and data collection.
- Manage site communications, address queries, and resolve issues promptly to ensure study progress.
- Monitor patient recruitment and retention efforts at study sites.
- Ensure the proper storage, handling, and accountability of investigational products and study supplies.
- Prepare detailed monitoring visit reports and follow up on action items.
- Collaborate with internal teams (e.g., project managers, data managers) to ensure smooth study execution.
- Maintain knowledge of therapeutic areas and relevant clinical trial methodologies.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
- In-depth knowledge of GCP guidelines, ICH regulations, and clinical trial processes.
- Proven experience in monitoring clinical trial sites and conducting source data verification.
- Excellent understanding of clinical trial documentation and regulatory requirements.
- Strong communication, interpersonal, and presentation skills.
- Ability to work independently, manage time effectively, and travel extensively within the Richards Bay, KwaZulu-Natal region and potentially other areas.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Attention to detail and strong organizational skills.
- A valid driver's license and access to a reliable vehicle are essential.
Benefits
- Our client offers a competitive salary, performance-based bonuses, comprehensive health insurance, and a company car/travel allowance.
- This role provides significant opportunities for professional development and career advancement within a growing pharmaceutical organization.
- Join our collaborative team in Richards Bay, KwaZulu-Natal, and play a vital role in bringing new treatments to patients.
- We offer a dynamic work environment that values innovation, integrity, and employee well-being, with ample opportunities for learning and skill enhancement.