Senior Clinical Research Associate (Cra)

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Professional development

Hybrid work model

Job summary

Placements24 is seeking a Senior Clinical Research Associate to oversee clinical trial sites, ensuring GCP compliance and proper data integrity. The role combines on-site monitoring in Nelspruit with remote administrative duties in a hybrid arrangement.

The ideal candidate has at least 5 years of CRA experience, strong communication skills, and a solid understanding of ICH-GCP and regulatory submissions. Travel to sites is required, and collaboration with cross-functional teams is essential.

Qualifications

• Bachelor's degree in a life science, nursing or related field.
• Minimum 5 years' CRA experience with successful site monitoring.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience monitoring multi-center trials across therapeutic areas.

Responsibilities

• Conduct pre-study, initiation, routine monitoring and close-out visits.
• Ensure adherence to study protocols, FDA/EMA/ICH-GCP, and SOPs.
• Verify accuracy of data through source data verification.
• Manage site communications and support investigators.
• Identify and track site issues, implement corrective actions.
• Ensure timely regulatory document submissions and accountability.
• Recruit, train and support trial site personnel.
• Collaborate with PMs, data management and other functions.
• Contribute to development/review of study documents including CRFs.

Skills

Communication skills

Interpersonal skills

Organizational skills

Travel readiness

Education

Bachelor's degree in life sciences / nursing / related field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a global Contract Research Organization (CRO) dedicated to advancing medical innovation, is seeking an experienced Senior Clinical Research Associate (CRA) to join their team. This crucial role involves overseeing and managing clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will play a key part in the successful execution of clinical studies, contributing to the development of new therapies. The ideal candidate possesses strong monitoring skills, excellent communication abilities, and a thorough understanding of the clinical trial process. This position is based in Nelspruit, Mpumalanga, with a hybrid work arrangement that balances on-site monitoring with remote administrative tasks. Join a leading organization that values scientific integrity and patient well-being.

Key Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites.
• Ensure adherence to study protocols, regulatory requirements (FDA, EMA, ICH-GCP), and company SOPs.
• Verify the accuracy, completeness, and integrity of clinical data through source document verification.
• Manage site communications, providing support and guidance to investigators and site staff.
• Identify, document, and track site issues, developing and implementing corrective action plans.
• Ensure timely submission of regulatory documents and investigational product accountability.
• Recruit, train, and provide ongoing support to clinical trial site personnel.
• Collaborate with project managers, data management, and other functional areas to ensure smooth trial execution.
• Contribute to the development and review of clinical study documents, including protocols and case report forms (CRFs).
• Maintain up-to-date knowledge of therapeutic areas and clinical trial methodologies.

Requirements

• Bachelor's degree in a life science, nursing, or a related field.
• Minimum of 5 years of experience as a Clinical Research Associate, with a proven track record of successful site monitoring.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Experience in monitoring multi-center clinical trials across various therapeutic areas.
• Strong understanding of clinical trial processes, including patient recruitment, data collection, and regulatory submissions.
• Excellent communication, interpersonal, and negotiation skills.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel extensively to clinical sites as required.
• Strong organizational skills and the ability to manage multiple priorities effectively.
• Detail-oriented with a commitment to quality and accuracy.
• Willingness to work a hybrid schedule in Nelspruit, Mpumalanga.

Benefits

Our client offers a highly competitive salary, a comprehensive benefits package including medical, dental, and vision insurance, and retirement savings options. Employees benefit from ongoing professional development opportunities, including training in new therapeutic areas and regulatory updates, as well as opportunities to attend industry conferences. The hybrid work model provides flexibility, combining essential on-site activities with remote administrative work. The company culture is focused on collaboration, innovation, and career growth. Join a dynamic CRO that is making a difference in global healthcare, based in the scenic region of Nelspruit, Mpumalanga.