About the Role
Our client, a leading pharmaceutical company dedicated to advancing medical treatments, is seeking a highly motivated and experienced Remote Pharmaceutical Clinical Research Associate (CRA). This is a fully remote position, allowing you to contribute to groundbreaking clinical trials from anywhere in South Africa. As a CRA, you will play a critical role in ensuring the quality, integrity, and compliance of clinical trial data by monitoring study sites. You will be responsible for verifying that trials are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and other applicable regulations. The ideal candidate possesses exceptional organizational skills, a meticulous attention to detail, and a strong understanding of clinical trial processes. Join a team committed to scientific excellence and patient well-being, working on cutting-edge therapies. This remote role offers the flexibility to manage your own schedule while making a significant impact on healthcare advancements. We are looking for a self-starter who can effectively manage relationships with investigative sites and internal stakeholders remotely.
Key Responsibilities
- Perform site selection, initiation, monitoring, and closing visits for clinical trials in compliance with the protocol and GCP guidelines.
- Ensure that clinical trial data is accurate, complete, and verifiable by reviewing source documents and case report forms (CRFs).
- Monitor study conduct at investigative sites, identifying and resolving issues to ensure data integrity and patient safety.
- Train and support site personnel on study procedures, regulatory requirements, and data collection.
- Maintain accurate and timely study documentation, including monitoring reports and site correspondence.
- Liaise between investigative sites, the clinical operations team, and other study-related departments.
- Ensure compliance with all applicable regulatory requirements and company SOPs.
- Assist in the development and review of clinical study protocols and other study-related documents.
- Manage relationships with investigators and site staff to foster positive collaboration.
- Report on site performance and identify trends or potential risks to study progression.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry or a Contract Research Organization (CRO).
- In-depth knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
- Proven experience in conducting site monitoring visits and managing clinical trial sites.
- Excellent understanding of clinical trial processes and documentation.
- Strong organizational, time management, and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and manage a remote workload effectively.
- Willingness to travel domestically as required for site visits (percentage may vary).
Benefits
- This is a fully remote position offering significant flexibility and autonomy.
- Our client provides a competitive salary package, including performance bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Opportunities for continuous professional development through training, workshops, and support for relevant certifications.
- A collaborative and supportive remote team environment.
- Exposure to cutting-edge clinical research and therapeutic areas.
- Contribution to impactful clinical trials that advance patient care.
- This role is an excellent opportunity for experienced CRAs looking for a remote position in the pharmaceutical industry.