About the Role
Our client, a globally recognized pharmaceutical research organization, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their expanding team. This position is fully remote, allowing you to contribute from anywhere while managing critical clinical trial activities. You will be responsible for overseeing and managing clinical trials across multiple sites, ensuring adherence to protocols, Good Clinical Practice (GCP), and all applicable regulations. This is a prime opportunity to advance your career in clinical research, working on impactful studies that drive therapeutic innovation, without the need for office presence. You'll leverage your expertise to ensure data integrity and patient safety from a remote setting, supporting vital research in the pharmaceutical sector.
Key Responsibilities
- Monitor clinical trial sites remotely to ensure compliance with study protocols, GCP, and regulatory requirements.
- Perform remote source data verification (SDV) and ensure the accuracy, completeness, and consistency of clinical data.
- Conduct remote site initiation, interim monitoring, and close-out visits.
- Train and support site staff on study-specific procedures and data collection.
- Manage investigational product accountability and reconciliation.
- Identify, resolve, and escalation site-level issues and deviations in a timely manner.
- Prepare monitoring reports and communicate effectively with investigators, site staff, and internal project teams.
- Ensure timely submission of essential documents and maintain site files.
- Contribute to the development of study-related documents, such as monitoring plans and case report forms (CRFs).
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a significant portion involving remote monitoring responsibilities.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in monitoring multi-center clinical trials.
- Excellent understanding of clinical trial processes and documentation.
- Strong organizational, time management, and problem-solving skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent interpersonal and communication skills, with the ability to build rapport and provide guidance remotely.
- Ability to work independently and manage a remote workload effectively.
Benefits
- Our client offers a highly competitive salary, comprehensive remote work benefits package, and the flexibility to work from anywhere in South Africa.
- They are committed to professional development and provide ample opportunities for career advancement.
- This role offers the chance to be part of groundbreaking pharmaceutical research while enjoying the advantages of a remote-first work environment.
- You will play a crucial role in advancing medical science from the comfort of your own home, contributing to significant clinical trial successes.