About the Role
Our client, a leading entity in the pharmaceutical sector, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic team based in Midrand, Gauteng. This is a critical role focused on overseeing and managing clinical trials to ensure compliance with regulatory standards and protocol requirements. The successful candidate will play an integral part in the drug development lifecycle, contributing to the advancement of innovative therapies. This position offers a unique opportunity to work with cutting-edge research and contribute significantly to public health outcomes. The role is designed for an individual who thrives in a collaborative environment and possesses a keen eye for detail. We are looking for a proactive individual who can independently manage trial sites and build strong relationships with investigators and site staff. The strategic location in Midrand, Gauteng , provides excellent accessibility and integration within a thriving business hub.
Key Responsibilities
- Plan, implement, and manage clinical trial activities at assigned sites.
- Ensure adherence to Good Clinical Practice (GCP), protocol guidelines, and all applicable regulatory requirements.
- Conduct site visits, including initiation, monitoring, and close-out visits, to assess patient recruitment, data quality, and overall trial progress.
- Train and support investigators and site staff on protocol procedures, data collection, and regulatory compliance.
- Manage and resolve issues related to site operations and data discrepancies.
- Prepare and present monitoring reports to the clinical trial team and management.
- Collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs.
- Maintain accurate and organized trial documentation.
- Contribute to the development of study protocols and case report forms.
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 site management, monitoring, and audit preparation.
- Excellent communication, interpersonal, and organizational skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and manage multiple priorities effectively.
- Strong problem-solving and analytical skills.
- Willingness to travel to assigned clinical trial sites as required.
- Fluency in English, both written and spoken.
Benefits
- Our client offers a competitive compensation package, including a performance-based bonus structure.
- Employees are provided with comprehensive health insurance, including medical and dental coverage.
- Opportunities for professional development and continuous learning are actively encouraged through internal and external training programs.
- A supportive and collaborative work environment fosters career growth.
- Access to state-of-the-art facilities and technologies.
- Paid time off includes annual leave, sick leave, and public holidays.
- Retirement savings plan contributions are also included.
- This role is based in the vibrant economic hub of Midrand, Gauteng .