About the Role
Our client, a leading pharmaceutical innovator, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic team. This fully remote position offers an exceptional opportunity to contribute to groundbreaking medical advancements from the comfort of your own home. You will be instrumental in ensuring the quality and integrity of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. This role demands a proactive approach, excellent organizational skills, and a passion for improving patient outcomes through rigorous scientific research. The successful candidate will work independently, managing multiple projects simultaneously while maintaining clear and consistent communication with all stakeholders. As a Senior CRA, you will play a crucial role in the drug development lifecycle, contributing to the successful execution of studies that could change lives.
Key Responsibilities
- Oversee and manage all aspects of clinical trial conduct at assigned investigational sites.
- Ensure compliance with study protocols, Good Clinical Practice (GCP) , and applicable regulatory requirements.
- Conduct site initiation, interim monitoring, and close-out visits remotely and/or on-site as needed, maintaining comprehensive visit reports.
- Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV) and query resolution.
- Manage site staff training and ensure they are adequately informed regarding study procedures and patient management.
- Monitor drug accountability and ensure proper storage and handling of investigational products.
- Act as the primary point of contact between the investigative sites and the sponsor.
- Identify, assess, and report adverse events (AEs) and serious adverse events (SAEs) promptly.
- Ensure timely submission of essential documents to the appropriate parties.
- Contribute to the development and review of clinical study documents, including protocols, case report forms (CRFs), and monitoring plans.
Requirements
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Thorough understanding of ICH-GCP guidelines and relevant regulatory frameworks (e.g., FDA, EMA).
- Demonstrated ability to manage multiple projects and sites effectively in a remote setting.
- Excellent verbal and written communication skills, with the ability to articulate complex information clearly.
- Strong problem-solving and critical-thinking abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently with minimal supervision and as part of a global team.
- Must be based in Johannesburg, Gauteng, ZA , and able to work remotely.
Benefits
- Competitive annual salary of R .
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and sick leave policy.
- Retirement savings plan with company matching.
- Opportunities for professional development and continuous learning.
- Access to cutting-edge research and development projects.
- A supportive and collaborative remote work environment.
- Company-provided home office equipment and technology stipend.