Senior Clinical Research Associate

Placements24; Pietermaritzburg; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Professional development

Job summary

Placements24 is seeking a Senior Clinical Research Associate to join their team in a fully remote role. You will oversee all aspects of clinical trial conduct, ensuring adherence to protocols, GCP, and regulatory standards from initiation through close-out.

The successful candidate will have at least 5 years of CRA experience in pharma, a life science degree, strong site relationships, and excellent organizational and communication skills to manage diverse projects from a home office.

Qualifications

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years of progressive experience as a Clinical Research Associate in the pharmaceutical industry.
• Extensive knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Proven experience in remote site monitoring and managing virtual relationships with investigators and site staff.

Responsibilities

• Initiate, monitor, and close-out clinical trial sites, ensuring compliance with GCP and regulatory requirements.
• Conduct site visits (remote or on-site as needed) to assess protocol adherence, data integrity, and patient safety.
• Train and mentor site staff on study protocols, clinical trial procedures, and data management.
• Manage site issues and elevate deviations or risks to project management and the clinical operations team.
• Review and verify CRFs, source documents, and study data for accuracy and completeness.

Skills

Remote monitoring

Communication

Project management

Attention to detail

GCP knowledge

Education

Bachelor's degree in life science

Advanced degree preferred

Job description

About the Role

Our client, a leading pharmaceutical entity, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dynamic team, operating fully remotely. This pivotal role involves overseeing all aspects of clinical trial conduct, ensuring adherence to protocols, regulations, and ethical standards. You will be instrumental in driving the success of critical research initiatives from initiation to close-out, contributing significantly to the development of life-saving medications. The ideal candidate will possess a deep understanding of pharmaceutical research processes and a proven ability to manage multiple complex projects concurrently within a distributed work environment, fostering strong relationships with study sites and internal stakeholders from their home office.

Key Responsibilities

• Initiate, monitor, and close-out clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements.
• Conduct site visits (remote or on-site as needed, though primary focus is remote engagement) to assess protocol adherence, data integrity, and patient safety.
• Train and mentor site staff on study protocols, clinical trial procedures , and data management.
• Manage site issues and elevate deviations or risks to project management and the clinical operations team promptly.
• Review and verify Case Report Forms (CRFs) , source documents, and study data for accuracy and completeness.

Requirements

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years of progressive experience as a Clinical Research Associate in the pharmaceutical industry.
• Extensive knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Proven experience in remote site monitoring and managing virtual relationships with investigators and site staff.
• Excellent organizational, communication, and problem-solving skills, with meticulous attention to detail.

Benefits

• Competitive annual salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off and holiday schedule.
• Opportunities for professional development and continuous learning in a remote setting.
• Access to cutting-edge research and development within the pharmaceutical sector .