About the Role
Our client, a prominent global pharmaceutical entity, is actively seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to join their expanding clinical operations team in Durban, KwaZulu-Natal . This critical role will involve overseeing the conduct of clinical trials at investigative sites, ensuring compliance with protocol, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities, playing a vital part in bringing life-changing therapies to patients. This position demands a proactive approach, meticulous attention to detail, and a strong understanding of clinical trial processes. The opportunity to contribute to groundbreaking research in a supportive and dynamic environment makes this role particularly appealing for career-driven professionals in Durban .
Key Responsibilities
- Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols and GCP guidelines.
- Ensure the accuracy, completeness, and quality of clinical data collected at investigational sites.
- Verify that study medication is administered, dispensed, and accounted for according to the protocol.
- Monitor patient safety and report adverse events and serious adverse events (SAEs) as per regulatory requirements and protocol.
- Build and maintain strong relationships with investigators, site staff, and study participants.
- Serve as the primary point of contact between the sponsor and investigative sites.
- Ensure compliance with all local and international regulatory requirements and ethical standards.
- Manage site-level regulatory document collection and maintenance.
- Prepare monitoring visit reports and follow up on action items in a timely manner.
- Contribute to the development of clinical trial protocols and other study-related documents.
- Assist in the training of new CRAs and site staff as needed.
- Act as a representative for our client at clinical sites in and around Durban .
Requirements
- Bachelor's degree in a life science, nursing, or a related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong organizational, problem-solving, and communication skills.
- Ability to work independently and manage time effectively to meet deadlines.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel extensively to investigational sites.
- Commitment to maintaining the highest ethical standards and data integrity.
Benefits
- Our client offers a competitive remuneration package, reflecting the importance of this role.
- This includes an attractive base salary, performance-based incentives, and a comprehensive benefits program.
- Benefits include excellent health coverage, life insurance, and a retirement savings plan.
- Opportunities for career advancement and professional development are actively encouraged through ongoing training and access to industry conferences.
- This position is based in our modern offices in Durban , providing a stimulating and collaborative professional atmosphere.
- Potential for travel to various clinical sites forms an integral part of the role.