About the Role
Join our client, a global leader in clinical research, as a Senior Clinical Research Associate (CRA) working entirely remotely. This position is designed for experienced CRAs who excel at managing clinical trial sites and ensuring data integrity from a distance. You will be responsible for monitoring study conduct, ensuring compliance with protocols, GCP, and regulatory requirements, and maintaining strong relationships with investigative sites. While the role is remote, it requires significant travel to sites as needed, though the primary mode of operation is from your home office. This is a pivotal role in driving successful clinical trial execution, supporting studies managed within the Pretoria, Gauteng region, and contributing to the development of life‑saving therapies.
Key Responsibilities
- Conduct pre-study, initiation, interim monitoring, and close‑out visits for clinical trial sites.
- Ensure study conduct adheres to the clinical protocol, GCP, and all applicable regulations.
- Verify the accuracy, completeness, and quality of clinical data by reviewing source documents and Case Report Forms (CRFs).
- Manage and mentor site staff, providing training and support on study procedures.
- Oversee site performance and implement corrective actions as necessary.
- Prepare and submit monitoring visit reports in a timely manner.
- Manage investigational product accountability and drug dispensing at study sites.
- Liaise with investigators, site staff, and the clinical study team to resolve study-related issues.
- Ensure timely collection of essential study documents from investigational sites.
- Participate in study team meetings and contribute to study planning and strategy.
- Maintain a high level of expertise in relevant therapeutic areas and regulatory requirements.
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, with a strong track record in monitoring complex clinical trials.
- In‑depth knowledge of ICH‑GCP guidelines and other relevant regulatory requirements.
- Demonstrated experience in therapeutic areas such as oncology, cardiology, or infectious diseases.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent communication, interpersonal, and negotiation skills.
- Strong organizational and time‑management abilities, with the capacity to manage multiple priorities.
- Ability to travel domestically and internationally as required (up to 60%).
- Self‑motivated and able to work effectively independently in a remote setting.
- Experience with remote monitoring techniques and technologies.
- Fluency in English (written and spoken).
Benefits
- Highly competitive annual salary of up to R .
- Fully remote work arrangement, offering excellent work‑life balance.
- Company car or mileage reimbursement for site visits.
- Comprehensive health, dental, and vision insurance.
- Generous allowance for professional development and training.
- Retirement savings plan with company contributions.
- Performance‑based bonuses and incentives.
- Supportive team environment and access to experienced colleagues.
- Opportunities to work on diverse and impactful clinical trials, supporting the Pretoria region.