About the Role
Our client is actively seeking a diligent and detail-oriented Clinical Research Associate (CRA) to support their ongoing clinical trials in Klerksdorp, North West . This role is integral to ensuring the integrity, accuracy, and timeliness of clinical trial data, as well as compliance with regulatory standards and protocols. The CRA will be responsible for site monitoring, ensuring investigational sites adhere to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This position offers a fantastic opportunity to be involved in the development of new therapies and to work within a dynamic research environment. You will collaborate closely with investigators, site staff, and internal project teams to facilitate the successful execution of clinical studies. The role demands strong organizational skills, excellent communication abilities, and a commitment to patient safety and data quality.
Key Responsibilities
- Conduct site initiation, routine monitoring, and close-out visits for clinical trial sites.
- Verify the accuracy, completeness, and validity of clinical trial data through source data verification.
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and all applicable regulatory requirements (e.g., ICH-GCP).
- Train and support investigators and site staff on study procedures and regulatory compliance.
- Manage site issues and deviations, implementing corrective and preventive actions (CAPAs).
- Prepare monitoring visit reports and communicate findings and action items to sites and internal stakeholders.
- Maintain study documentation and ensure essential documents are accurate and up-to-date.
- Build and maintain strong working relationships with clinical trial sites and investigators.
Requirements
- Bachelor's degree in a life science, nursing, or related discipline.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in conducting site monitoring visits and data verification.
- Excellent communication, interpersonal, and organizational skills.
- Ability to manage multiple priorities and work independently.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel frequently to assigned clinical trial sites within the Klerksdorp, North West region and potentially beyond.
Benefits
- Our client offers a competitive compensation package, including a generous salary, performance bonuses, and comprehensive benefits such as medical aid and retirement planning.
- This role provides significant opportunities for professional growth and development within the clinical research field.
- The position is based in Klerksdorp, North West , offering a challenging yet rewarding career path.
- We invest in our employees through ongoing training, professional development programs, and support for continuing education.
- A car allowance and travel expenses are provided to facilitate site visits.
- Our client fosters a collaborative and supportive work environment where your contributions are valued and recognized.
- Regular performance reviews and career pathing discussions ensure your professional journey is well-supported.