Remote Senior Clinical Research Associate (CRA)

Placements24; Johannesburg; Hybrid; ZAR 780,000 - 1,100,000; Full time

Job summary

Placements24 is seeking an experienced Senior Clinical Research Associate to support our remote SA team. The role focuses on monitoring sites, ensuring protocol and ICH-GCP compliance, and maintaining data integrity across trials.

Candidates should have 5+ years in CRA roles within the pharmaceutical industry and strong experience with EDC/CTMS. The position offers remote work from anywhere in South Africa, with autonomy to manage a remote workload and coordinate across global teams to advance

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy or related field.
• Minimum of 5 years as a Clinical Research Associate in pharma.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Experience with remote and on-site monitoring and site management.
• Proficient with EDC and CTMS systems.
• Excellent organizational, time management and problem-solving skills.

Responsibilities

• Perform remote and on-site monitoring visits to clinical trial sites in compliance with protocol and ICH-GCP.
• Assess, train and educate site staff on protocol requirements and drug accountability.
• Manage assigned sites to ensure timely recruitment and retention of subjects.
• Oversee data collection, review and reporting of clinical data.
• Prepare regulatory documents for sites and ensure proper documentation.
• Communicate effectively with investigators, site staff and internal teams.
• Identify and resolve site-level issues and risks proactively.
• Contribute to study team meetings and monitor site performance.

Skills

ICH-GCP knowledge

Remote monitoring

On-site monitoring

Site management

Data integrity

Independent work

Communication skills

Organization

Education

Bachelor's degree in Life Sciences

Nursing or Pharmacy background

Advanced degree preferred

Tools

EDC systems

CTMS

Job description

About the Role

Our client, a globally recognized leader in pharmaceutical innovation, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their fully remote team. This position is integral to the successful execution of clinical trials, ensuring adherence to regulatory standards, protocols, and quality guidelines. As a remote-first employee, you will have the flexibility to work from anywhere within South Africa, contributing to groundbreaking research that shapes the future of medicine. You will be a key player in managing clinical trial sites, conducting monitoring visits, and ensuring data integrity, all while maintaining seamless communication with internal teams and external partners. This role demands a high degree of autonomy, exceptional organizational skills, and a deep understanding of the pharmaceutical industry's complexities. You will be empowered to manage your workload efficiently and contribute meaningfully to projects that impact patient lives worldwide, leveraging technology to foster collaboration and achieve project milestones. The focus is on proactive management and problem-solving, ensuring trials progress smoothly and efficiently from initiation to closure.

Key Responsibilities

• Perform remote and on-site monitoring visits to clinical trial sites, ensuring compliance with protocol, ICH-GCP, and regulatory requirements.
• Assess, train, and educate site staff on protocol requirements, drug accountability, and clinical trial procedures.
• Manage assigned clinical trial sites, ensuring timely subject recruitment and retention.
• Oversee the accurate and timely collection, review, and reporting of clinical data.
• Prepare and maintain essential regulatory documents for assigned sites.
• Communicate effectively with investigators, site staff, and internal project teams regarding site status and any issues.
• Identify, track, and resolve site-level issues and risks proactively.
• Participate in study team meetings and provide updates on site performance.
• Ensure timely submission of monitoring reports and other required documentation.
• Contribute to the development and review of clinical trial protocols and other study documents as needed.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
• Strong knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Proven experience in performing remote and on-site site monitoring.
• Excellent understanding of clinical trial processes, from site selection to study close-out.
• Proficiency in using Electronic Data Capture (EDC) systems and other clinical trial management software.
• Exceptional organizational, time management, and problem-solving skills.
• Strong verbal and written communication skills, with the ability to build rapport with site personnel.
• Ability to work independently and manage a remote workload effectively.
• Must be based in South Africa and eligible to work remotely.

Benefits

• This role offers a competitive salary and benefits package commensurate with experience.
• As a fully remote position, it provides unparalleled flexibility and work-life balance.
• Our client invests heavily in professional development, offering opportunities for continuous learning, advanced training, and career advancement within their global organization.
• Employees have access to cutting-edge technology and resources to support their work, fostering an environment of innovation and collaboration.
• We provide a supportive and engaging remote work culture, encouraging regular virtual team interactions and knowledge sharing.
• This is an exceptional opportunity to contribute to vital pharmaceutical research from the comfort of your home, making a tangible difference in healthcare outcomes.