Senior Clinical Research Associate - Pharmaceutical R&D

Placements24; Johannesburg; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary

Performance bonuses

Pension fund

Medical aid coverage

Professional development and training

State-of-the-art facilities

Hybrid work model

Job summary

Placements24 is seeking a Senior Clinical Research Associate (SCRA) to join their team in Johannesburg, Gauteng. The role focuses on overseeing clinical trial activities while ensuring regulatory compliance and data integrity across diverse therapeutic areas.

A hybrid work model blends on-site collaboration with remote flexibility. The SCRA will manage site initiation, monitoring, and close-out visits, train site staff, and coordinate with data management, biostatistics, and regulatory affairs

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• A Master's degree is preferred.
• Minimum of 5 years of experience as a CRA or Senior CRA in the pharmaceutical industry.
• In-depth knowledge of clinical trial methodologies, GCP, ICH guidelines, and regulatory requirements in South Africa.
• Proven experience in site management, monitoring, and regulatory compliance.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in clinical trial management software and the Microsoft Office Suite.
• Ability to work independently and in a hybrid environment.

Responsibilities

• Develop, manage, and execute clinical trial protocols in compliance with GCP, ICH, and regulatory requirements.
• Identify, evaluate, and select sites for clinical trial participation.
• Conduct site initiation, monitoring, and close-out visits to ensure data accuracy, patient safety, and adherence to protocols.
• Train and support site staff on trial procedures, regulatory requirements, and data collection.
• Manage study timelines, budgets, and resources effectively.
• Prepare and present study progress reports to internal stakeholders and regulatory bodies.
• Oversee the collection, review, and management of clinical data, ensuring its quality and completeness.
• Identify and resolve issues that may impact study progress or data integrity.
• Liaise with cross-functional teams, including data management, biostatistics, and regulatory affairs.
• Contribute to the development of clinical study reports and regulatory submissions.

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field

Master's degree preferred

Tools

EDC systems

Microsoft Office Suite

Job description

About the Role

Our client, a leading pharmaceutical innovator, is seeking a highly motivated and experienced Senior Clinical Research Associate (SCRA) to join their dynamic team in Johannesburg, Gauteng . This is a critical role contributing to the advancement of groundbreaking therapies. The SCRA will play a pivotal part in overseeing and managing clinical trial activities, ensuring compliance with regulatory standards and the integrity of study data. This position offers a unique opportunity to work on diverse therapeutic areas and contribute significantly to bringing life-changing medications to market. The role involves a Hybrid work model, blending on-site collaboration with remote flexibility, allowing for optimal work-life balance while maintaining close connections with the research team.

Key Responsibilities

• Develop, manage, and execute clinical trial protocols in compliance with GCP, ICH, and regulatory requirements.
• Identify, evaluate, and select sites for clinical trial participation.
• Conduct site initiation, monitoring, and close-out visits to ensure data accuracy, patient safety, and adherence to protocols.
• Train and support site staff on trial procedures, regulatory requirements, and data collection.
• Manage study timelines, budgets, and resources effectively.
• Prepare and present study progress reports to internal stakeholders and regulatory bodies.
• Oversee the collection, review, and management of clinical data, ensuring its quality and completeness.
• Identify and resolve issues that may impact study progress or data integrity.
• Liaise with cross-functional teams, including data management, biostatistics, and regulatory affairs.
• Contribute to the development of clinical study reports and regulatory submissions.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• A Master's degree is preferred.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) or Senior CRA in the pharmaceutical industry.
• In-depth knowledge of clinical trial methodologies, GCP, ICH guidelines, and relevant regulatory requirements in South Africa .
• Proven experience in site management, monitoring, and regulatory compliance.
• Excellent understanding of clinical trial documentation and electronic data capture (EDC) systems.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Proficiency in Microsoft Office Suite and clinical trial management software.
• Ability to work independently and as part of a collaborative team in a Hybrid environment.
• A valid driver's license and willingness to travel within the designated region.

Benefits

• competitive annual salary, performance-based bonuses, a generous pension fund, comprehensive medical aid coverage, and opportunities for continuous professional development and training
• You will also have access to state-of-the-art facilities and the chance to work alongside industry experts.
• The hybrid work model allows for greater flexibility, and our client fosters a supportive and collaborative work culture.