About the Role
Our client, a leading Contract Research Organization (CRO) serving the pharmaceutical industry, is actively seeking a dedicated and experienced Remote Pharmaceutical Clinical Research Associate (CRA). This fully remote position offers the flexibility to work from your home office anywhere in **South Africa**. You will be responsible for monitoring clinical trial sites, ensuring data integrity, patient safety, and adherence to protocol and regulatory guidelines. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to manage multiple sites and tasks effectively. This remote CRA role is crucial for the successful execution of clinical trials that bring innovative therapies to market.
Key Responsibilities
- Conduct site initiation, interim, and close-out monitoring visits (remotely and on-site as required).
- Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
- Ensure compliance with Good Clinical Practice (GCP), protocol requirements, and applicable regulations.
- Train and support site staff on study procedures and data collection.
- Manage site communications and resolve issues promptly.
- Oversee site budget and resource management.
- Prepare monitoring reports and track action items.
- Ensure timely submission of essential study documents.
- Contribute to the development and review of study protocols and case report forms (CRFs).
- Maintain strong relationships with investigators and site personnel.
- Effectively manage multiple clinical trial sites in a remote capacity.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry or a CRO.
- In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
- Proven experience in site monitoring, SDV, and regulatory compliance.
- Excellent understanding of clinical trial processes and documentation.
- Strong organizational, time management, and problem-solving skills.
- Exceptional communication and interpersonal skills, with the ability to build rapport remotely.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Ability to travel nationally as required for on-site monitoring visits.
- Must have a dedicated home office space and reliable internet connectivity.
Benefits
- Our client offers a competitive salary, comprehensive health benefits, retirement plan, and performance-based bonuses.
- We provide extensive training and opportunities for career advancement within a growing organization.
- This fully remote position offers significant flexibility and work-life balance.
Join a dedicated team making a real difference in the development of new medicines and therapies.