About the Role
Our client, a rapidly expanding Contract Research Organization (CRO), is seeking a motivated and experienced Senior Clinical Research Associate (CRA) to join their team in Rustenburg, North West . This role is crucial for overseeing and managing clinical trials across various therapeutic areas. As a Senior CRA, you will be responsible for ensuring the quality and integrity of clinical trial data, compliance with protocols, and adherence to Good Clinical Practice (GCP) guidelines. This position offers an excellent opportunity to work on diverse and impactful clinical studies while advancing your career in clinical research. We are dedicated to supporting our employees' professional development and providing a stimulating work environment at our Rustenburg site.
Key Responsibilities
- Conduct site initiation, monitoring, and close-out visits to ensure compliance with protocols and GCP.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification.
- Manage investigational product accountability at study sites.
- Build and maintain strong relationships with investigators, site staff, and other stakeholders.
- Identify, evaluate, and recommend potential clinical trial sites.
- Prepare and present study-related documents, including monitoring reports and essential regulatory documents.
- Ensure timely resolution of site issues and action items.
- Train and mentor junior CRAs and site personnel as needed.
- Uphold the highest standards of ethical conduct and data integrity throughout all clinical trial activities conducted in the Rustenburg region.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
- Minimum of 5 years of experience as a Clinical Research Associate, with at least 2 years at a senior level.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in conducting site monitoring visits and managing clinical trial documentation.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong organizational, time management, and problem-solving skills.
- Effective communication and interpersonal skills, with the ability to influence and negotiate.
- Willingness to travel extensively to clinical trial sites within the Rustenburg area and surrounding regions.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Benefits
- Competitive annual salary of ZAR .
- Travel allowances and per diem for site visits.
- Comprehensive medical and retirement benefits.
- Opportunities for professional development and certifications.
- Flexible work arrangements for a healthy work-life balance in Rustenburg .
- Exposure to a wide range of therapeutic areas and innovative research projects.