Senior Clinical Research Associate in Pharmaceutical Development

Placements24; KwaZulu-Natal; Hybrid; ZAR 700,000 - 900,000; Full time

Benefits offered by this job

Private medical insurance

Retirement savings plan

Generous paid time off

Professional development opportunities

Job summary

Placements24 in Pietermaritzburg, KwaZulu-Natal, is seeking a Senior Clinical Research Associate to oversee site monitoring, ensure GCP compliance, and support trial execution within a hybrid work setup.

The candidate will collaborate with investigators, manage regulatory documents, train staff, and contribute to data quality while traveling to sites as required; a life sciences degree and 5 years CRA experience are expected.

Qualifications

• Bachelor's degree in life sciences or related field.
• Master's degree or higher is advantageous.
• Minimum of 5 years as a Clinical Research Associate in pharma/biotech.
• Knowledge of ICH-GCP guidelines and local regulatory requirements.
• Experience monitoring trials across multiple therapeutic areas.
• Proficient with CTMS and EDC systems.
• Excellent communication and organizational skills.
• Ability to travel to clinical sites within the region in a hybrid work setup.

Responsibilities

• Oversee and monitor multiple trial sites ensuring compliance with study protocols and GCP.
• Conduct site initiation, monitoring, and close-out visits to assess progress and data integrity.
• Collaborate with investigators and staff to resolve trial issues and ensure timely data collection.
• Prepare and present monitoring reports highlighting findings and actions.
• Maintain regulatory documents and site files accurately and up-to-date.
• Assist in development of study protocols and CRFs.
• Train and mentor junior CRAs and support continuous learning.
• Participate in cross-functional meetings to optimize trial conduct.
• Ensure ethical treatment and safety of trial participants throughout the lifecycle.
• Coordinate communication between sites and operations teams.

Skills

Communication skills

Interpersonal skills

Organizational skills

Attention to detail

Travel readiness

Education

Bachelor's degree in life sciences/healthcare

Master's degree (advantage)

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading name in the pharmaceutical industry, is seeking a highly motivated and experienced Senior Clinical Research Associate (CRA) to join their dynamic team in Pietermaritzburg, KwaZulu-Natal . This is a pivotal role within our client's drug development pipeline, focused on ensuring the meticulous planning, execution, and monitoring of clinical trials. The successful candidate will play a crucial part in bringing life-changing therapies to market, adhering to the highest ethical and scientific standards. This position offers a unique opportunity to contribute to cutting-edge research in a supportive and collaborative environment. The role requires a blend of on-site engagement for essential team meetings and site visits, complemented by the flexibility of remote work for data analysis and report generation, making it an ideal 'Hybrid' opportunity.

Key Responsibilities

• Oversee and manage multiple clinical trial sites, ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Conduct site initiation, monitoring, and close-out visits to assess trial progress, data accuracy, and subject safety.
• Collaborate closely with investigators, site staff, and internal teams to resolve any trial-related issues and ensure timely data collection.
• Prepare and present comprehensive monitoring reports, highlighting findings, action items, and resolutions.
• Maintain accurate and up-to-date trial documentation, including essential regulatory documents and site files.
• Assist in the development of study protocols, case report forms (CRFs), and other study-related documents.
• Train and mentor junior CRAs, fostering a culture of continuous learning and professional development.
• Participate in cross-functional team meetings, contributing insights and expertise to optimize trial conduct.
• Ensure the ethical treatment and safety of trial participants throughout the study lifecycle.
• Manage communication between study sites, the clinical operations team, and other relevant stakeholders.

Requirements

• A Bachelor's degree in a life science, nursing, or a related healthcare field is required.
• A Master's degree or higher is advantageous.
• Minimum of 5 years of progressive experience as a Clinical Research Associate within the pharmaceutical or biotechnology sector.
• Demonstrable knowledge of ICH-GCP guidelines, local regulatory requirements, and clinical trial methodologies.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent communication, interpersonal, and organizational skills, with a keen eye for detail.
• Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Ability to work independently and manage time effectively in a hybrid work environment.
• Strong problem-solving abilities and a proactive approach to identifying and addressing challenges.
• Willingness to travel to clinical sites within the region as required.
• Must be legally authorized to work in South Africa.

Benefits

Our client offers a highly competitive remuneration package, including a generous annual salary and performance-based bonuses. Employees benefit from comprehensive private medical insurance, a robust retirement savings plan, and ample paid time off. Professional development is strongly encouraged, with opportunities for advanced training, certifications, and conference attendance. Our client also provides a supportive work environment that promotes work-life balance, access to employee wellness programs, and career advancement prospects within the organization. Relocation assistance may be available for exceptional candidates moving to Pietermaritzburg, KwaZulu-Natal .