About the Role
Our client, a dynamic and growing pharmaceutical company focused on innovative treatments, is seeking a highly motivated and experienced Clinical Research Associate (CRA) to join their fully remote clinical operations team. This position is critical for overseeing the successful execution of clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. As a remote CRA, you will conduct site visits (virtual or on-site as required), monitor trial progress, manage data integrity, and serve as the primary liaison between investigational sites and the study team. We foster a remote-first culture, providing robust support systems, advanced technological tools, and a collaborative environment to enable our team members to thrive professionally while maintaining excellent work-life integration. Your expertise will directly contribute to bringing life-changing therapies to patients worldwide.
Key Responsibilities
- Monitor assigned clinical trial sites to ensure compliance with protocol, GCP, and regulatory requirements.
- Conduct pre-study, initiation, interim, and close-out visits (potentially remotely or on-site as dictated by study needs).
- Verify accuracy, completeness, and consistency of data through source data verification (SDV) and review of Case Report Forms (CRFs).
- Manage and resolve site-related issues, escalating as necessary to the Clinical Trial Manager.
- Ensure timely submission of all required trial documentation and reports.
- Train and mentor investigators and site staff on study procedures and data collection.
- Manage drug accountability and investigational product supplies at study sites.
- Facilitate communication between investigators, study coordinators, and internal study teams.
- Maintain updated Trial Master File (TMF) documentation.
- Participate in study team meetings and provide regular updates on site performance.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or related field.
- Minimum of 3 years of experience as a Clinical Research Associate in the pharmaceutical or CRO industry.
- Thorough understanding of ICH-GCP guidelines and regulatory requirements.
- Proven experience in monitoring clinical trials across various therapeutic areas.
- Excellent SDV skills and attention to detail in data review.
- Strong organizational, communication, and interpersonal skills.
- Ability to work independently, manage time effectively, and travel as required (if applicable for hybrid elements).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Must have a dedicated home office space conducive to remote work.
- Adaptability and a proactive approach to problem-solving in a remote setting.
Benefits
- Competitive annual salary of ZAR.
- Comprehensive healthcare coverage, including medical, dental, and vision.
- Retirement savings plan options.
- Generous annual leave and sick leave allowance.
- Opportunities for professional development, training, and certifications.
- Fully remote work arrangement, fostering flexibility and work-life balance.
- Company-provided laptop and mobile phone.
- Travel expense reimbursement when on-site visits are required.