About the Role
Our client, a leading innovator in the Pharmaceutical industry, is actively seeking a highly experienced Senior Clinical Research Associate (CRA) to join their expanding global team. This role is specifically designed to be fully remote, allowing exceptional professionals to contribute their expertise from anywhere. You will play a crucial role in the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards. As a Senior CRA, you will be instrumental in overseeing multiple trial sites, driving data integrity, and ensuring the timely completion of critical research milestones. This is an outstanding opportunity to work on groundbreaking Pharmaceutical projects, collaborate with a diverse and talented group of professionals, and advance your career in a flexible, remote-first environment. Your contributions will directly impact the development of life-changing therapies, making this a deeply rewarding position within the Western Cape, ZA region and beyond.
Key Responsibilities
- Conduct pre-study, interim, and close-out visits for clinical trial sites to assess protocol and regulatory compliance.
- Ensure accurate, complete, and timely collection and reporting of clinical trial data.
- Monitor study conduct to ensure patient safety and data integrity throughout the trial lifecycle.
- Train and support site staff on study-specific procedures and regulatory requirements.
- Manage site-level activities, including essential document management and investigational product accountability.
- Identify, document, and elevate study-related issues and risks to study management.
- Build and maintain strong working relationships with investigators, site staff, and internal project teams.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable local and international regulations.
- Contribute to the development of study-related documents, such as protocols, informed consent forms, and case report forms.
- Perform remote monitoring activities as required, utilizing electronic data capture (EDC) systems and other technologies.
Requirements
- Bachelor's degree in a life science, nursing, or related discipline; advanced degree preferred.
- Minimum of 7 years of direct experience as a Clinical Research Associate in the Pharmaceutical or biotechnology industry.
- Thorough understanding of GCP, ICH guidelines, and clinical trial regulations.
- Proven ability to manage multiple clinical trials and sites independently.
- Experience with EDC systems and other clinical trial management software.
- Excellent organizational, time management, and communication skills.
- Ability to work autonomously and effectively in a remote setting.
- Strong attention to detail and commitment to data accuracy and patient safety.
- Willingness to travel domestically and internationally as needed (though primarily remote).
- Familiarity with the Western Cape, ZA research landscape is a plus.
Benefits
- Highly competitive salary and potential for performance bonuses.
- Comprehensive health, dental, and vision insurance coverage.
- Retirement savings plan with company matching contributions.
- Significant home office stipend to create an optimal remote workspace.
- Generous annual leave and paid sick days.
- Professional development opportunities, including access to online courses and workshops.
- Opportunity to work with a globally recognized leader in Pharmaceutical research.
- Flexible work schedule within a remote work structure.