Remote Clinical Research Associate - Global Drug Trials

Placements24; Cape Town; Hybrid; ZAR 500,000 - 800,000; Full time

Job summary

Placements24 is seeking an experienced Remote Clinical Research Associate to join a global drug development team. You will monitor trial sites remotely, verify data, and ensure GCP compliance from your location.

The role emphasizes collaboration with investigators, site staff, and internal study teams to uphold data integrity and patient safety. Requirements include a life sciences-related bachelor's degree and 3+ years of CRA experience, with a regulatory-savvy mindset and strong organizational

Qualifications

• Minimum 3 years of CRA experience in clinical research.
• Thorough understanding of trial processes and GCP.
• Experience with remote monitoring tools.
• Proficient in CTMS and EDC systems.
• Eligible to work remotely in the designated region.

Responsibilities

• Conduct remote monitoring of trial sites to ensure protocol adherence.
• Verify data accuracy through remote SDV and data verification.
• Ensure compliance with GCP, FDA regulations, and guidelines.
• Maintain relationships with investigators and site staff.
• Identify risks and implement corrective actions at sites.
• Support site initiation, monitoring, and close-out activities.
• Submit timely monitoring reports and study documents.
• Participate in training to stay current with industry practices.
• Contribute to overall trial quality and patient safety.

Skills

Remote monitoring

SDV

GCP knowledge

CTMS

EDC systems

Data integrity

Regulatory knowledge

Time management

Communication

Independent work

Education

Bachelor's degree

Master's degree

Tools

CTMS

EDC

Job description

About the Role

Our client, a leading global pharmaceutical company, is actively seeking experienced and dedicated Remote Clinical Research Associates (CRAs) to join their expansive drug development team. This is a fully remote position, allowing you to contribute significantly to global clinical trials from your own location. As a Remote CRA, you will be instrumental in ensuring the smooth execution of clinical studies by monitoring trial sites, verifying data integrity, and ensuring compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines. You will collaborate closely with investigators, site staff, and internal study teams to facilitate efficient and ethical clinical research. This role is crucial for bringing innovative and potentially life-saving therapies to market. We are looking for proactive individuals with a strong commitment to quality and patient safety.

Key Responsibilities

• Conduct remote monitoring activities of clinical trial sites to ensure adherence to protocols, SOPs, and regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data through remote source data verification (SDV).
• Ensure compliance with GCP, FDA regulations, and other applicable guidelines.
• Manage communication and build strong relationships with clinical investigators and site staff.
• Identify potential risks and issues at clinical sites and implement appropriate action plans.
• Support site initiation, monitoring, and close-out activities as required.
• Ensure timely submission of monitoring reports and other study-related documentation.
• Participate in training and development activities to stay current with industry best practices.
• Assist in the preparation of study-related documents and materials.
• Contribute to the overall quality and success of clinical trials conducted by the company.
• Ensure all activities are conducted with the utmost attention to patient safety and data integrity.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
• A Master's degree is a plus.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or equivalent role in clinical research.
• Thorough understanding of clinical trial processes, GCP, and relevant regulatory guidelines (e.g., ICH-GCP, FDA regulations).
• Proven experience with remote monitoring techniques and tools.
• Excellent organizational, time management, and problem-solving skills.
• Strong interpersonal and communication skills, with the ability to work effectively with diverse stakeholders.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently with minimal supervision and manage workload effectively.
• Detail-oriented with a strong commitment to quality and accuracy.
• Must be legally eligible to work remotely in the designated region.

Benefits

This is a fully remote position offering flexibility and work-life balance. Our client provides a competitive salary, comprehensive health and wellness benefits, retirement savings plans, and performance-based bonuses. Continuous professional development opportunities and access to cutting-edge clinical research technologies are provided. This role offers the chance to make a significant impact on global health outcomes from the convenience of your home.