Senior Clinical Research Associate

Placements24; Centurion; Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Competitive remuneration

Professional development opportunities

Diverse clinical trials exposure

Collaborative work environment

Job summary

Placements24 is seeking a highly experienced Senior Clinical Research Associate (CRA) to oversee multinational trials from Centurion, Gauteng, SA. You will lead site initiation, monitoring, and close-out visits, ensuring data integrity and patient safety in line with ICH-GCP guidelines.

The role requires 5-7 years as CRA, strong regulatory knowledge, proficiency with EDC/CTMS, and the ability to travel 50-60%.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• Advanced degree preferred.
• Minimum of 5-7 years of experience as a Clinical Research Associate.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements in clinical research.
• Proven experience in monitoring multi-center clinical trials across various therapeutic areas.
• Excellent understanding of clinical trial processes from study start-up to close-out.
• Strong organizational, time management, and problem-solving skills.
• Exceptional written and verbal communication skills, with strong interpersonal abilities.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to investigational sites as required (approx. 50-60%).
• Experience working with CROs is highly advantageous.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits according to study protocols and GCP.
• Ensure compliance with regulatory requirements, SOPs, and clinical trial protocols.
• Manage investigational sites, build strong relationships with investigators and site staff.
• Oversee data collection, source document verification, and query resolution.
• Ensure patient safety and adherence to ethical principles throughout the trial.
• Train and mentor junior CRAs and site personnel.
• Prepare monitoring reports and elevate issues to project management promptly.
• Participate in protocol development and site feasibility assessments.
• Manage study supplies and drug accountability at investigational sites.
• Contribute to the development and review of study-related documents.

Skills

GCP knowledge

Regulatory knowledge

Communication skills

Project management

Travel willingness

Education

Bachelor's degree in life science

Advanced degree preferred

Tools

EDC systems

CTMS

Job description

About the Role

Our client, a rapidly growing Contract Research Organization (CRO) with a strong presence in Centurion, Gauteng, ZA, is seeking a highly experienced Senior Clinical Research Associate (CRA) to oversee clinical trials. This role is crucial for ensuring the successful execution of clinical studies in compliance with regulatory standards and protocols. You will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data integrity and patient safety. The ideal candidate will possess extensive experience in clinical trial management, a deep understanding of Good Clinical Practice (GCP) guidelines, and excellent communication and interpersonal skills. This position offers a dynamic and challenging work environment with the opportunity to contribute to significant advancements in healthcare research. Join our dedicated team in Centurion and play a vital role in bringing new therapies to patients. We offer a hybrid work model, combining the benefits of remote work with essential on-site collaboration.

Key Responsibilities

Conduct site initiation, monitoring, and close-out visits according to study protocols and GCP. Ensure compliance with regulatory requirements, SOPs, and clinical trial protocols. Manage investigational sites, build strong relationships with investigators and site staff. Oversee data collection, source document verification, and query resolution. Ensure patient safety and adherence to ethical principles throughout the trial. Train and mentor junior CRAs and site personnel. Prepare monitoring reports and elevate issues to project management promptly. Participate in protocol development and site feasibility assessments. Manage study supplies and drug accountability at investigational sites. Contribute to the development and review of study-related documents.

Requirements

Bachelor's degree in a life science, nursing, or related field; advanced degree preferred. Minimum of 5-7 years of experience as a Clinical Research Associate. In-depth knowledge of ICH-GCP guidelines and regulatory requirements in clinical research. Proven experience in monitoring multi-center clinical trials across various therapeutic areas. Excellent understanding of clinical trial processes from study start-up to close-out. Strong organizational, time management, and problem-solving skills. Exceptional written and verbal communication skills, with strong interpersonal abilities. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Ability to travel to investigational sites as required (approx. 50-60%). Experience working with CROs is highly advantageous.

Benefits

• Our client offers a competitive remuneration package for this contractor role.
• Comprehensive benefits may be available, subject to contract terms.
• Opportunities for professional development and engagement in diverse clinical trials.
• Potential for long-term engagement based on performance and project needs.
• Access to a network of experienced clinical research professionals.
• A collaborative and supportive work environment within the Centurion area.
• We promote a culture of quality, compliance, and ethical research conduct.