About the Role
Our client, a leading pharmaceutical organization dedicated to advancing healthcare, is seeking a skilled and experienced Pharmaceutical Clinical Research Associate (CRA) to join their team in Soweto, Gauteng. This integral role involves monitoring clinical trials to ensure data accuracy, patient safety, and adherence to protocols and regulatory standards. You will be responsible for site visits, data review, and ensuring that all trial activities are conducted in accordance with Good Clinical Practice (GCP) guidelines. The ideal candidate will have a strong background in clinical research and a meticulous approach to monitoring and documentation. This is an exceptional opportunity to contribute to the development of life-changing medicines and build a rewarding career in clinical research. We are looking for a proactive professional committed to the highest standards of clinical trial conduct.
Key Responsibilities
- Conduct site visits (initiation, interim, and close-out) to monitor clinical trial progress and ensure protocol compliance.
- Verify the accuracy and completeness of clinical trial data through source document verification.
- Ensure patient safety and adherence to study protocols, GCP, and applicable regulatory requirements.
- Train and support site staff on study procedures, data collection, and regulatory compliance.
- Manage communication between investigative sites and the sponsor.
- Identify and resolve site-level issues and deviations, escalating when necessary.
- Oversee the regulatory, safety, and quality aspects of clinical trials at assigned sites.
- Prepare and submit monitoring reports in a timely manner.
- Maintain essential trial documents and ensure proper filing and archiving.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in site monitoring, data review, and query resolution.
- Strong understanding of clinical trial processes and pharmaceutical development.
- Excellent organizational, time management, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to build rapport with site staff.
- Ability to travel regularly to clinical trial sites.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems is a plus.
Benefits
- Our client offers a competitive salary package commensurate with your experience and expertise, along with performance-based incentives.
- Comprehensive benefits include medical, dental, and vision insurance, a retirement savings plan, and generous paid time off.
- Opportunities for professional development and career advancement within the clinical research field are provided.
- This hybrid role is based in Soweto, Gauteng, offering a challenging and rewarding career in pharmaceutical clinical research.