Senior Clinical Research Associate - Pharmaceutical Development

Placements24; Pietermaritzburg; Hybrid; ZAR 950,000 - 1,150,000; Full time

Benefits offered by this job

Competitive salary package

Health, dental & vision insurance

Generous paid time off

Professional development

Retirement plan with company match

State-of-the-art facilities

Employee assistance program

Career advancement opportunities

Job summary

Placements24 is seeking a Senior Clinical Research Associate for a hybrid role in Pietermaritzburg, KwaZulu-Natal. The successful candidate will oversee all aspects of clinical trials, ensure GCP compliance, and collaborate with data management, biostatistics, and regulatory affairs teams.

The role requires 5+ years as a CRA, strong regulatory knowledge, and excellent communication. This position offers a mix of office-based and remote work and opportunities for professional development.

Qualifications

• Minimum 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• Deep knowledge of ICH-GCP guidelines, FDA regulations, and other regulatory frameworks.
• Proven monitor experience: site initiation, routine monitoring, and close-out visits.
• Strong communication and collaboration with diverse stakeholders.
• Proficiency in CTMS and EDC systems.

Responsibilities

• Oversee and manage all aspects of assigned clinical trials in line with protocols and regulatory standards.
• Conduct site initiation visits, monitoring visits, and close-out visits to ensure data integrity and patient safety.
• Mentor junior staff and collaborate with investigators and internal project teams.
• Prepare study progress reports and manage trial documentation, ISFs, and essential documents.
• Support development and review of trial protocols, informed consent forms, and study documents.

Skills

CRA experience

ICH-GCP knowledge

FDA regulations knowledge

CTMS proficiency

EDC proficiency

Education

Bachelor's degree in life sciences

Master's degree (preferred)

Tools

CTMS

EDC

Job description

About the Role

Our client, a leading entity in the pharmaceutical sector, is seeking a highly experienced and motivated Senior Clinical Research Associate (SCRA) to join their dynamic team in Pietermaritzburg, KwaZulu-Natal. This role is crucial for overseeing and managing clinical trial operations, ensuring compliance with regulatory standards, and contributing to the successful development of groundbreaking pharmaceuticals. The SCRA will play a pivotal part in advancing our client's research pipeline, making a tangible impact on public health. This is an exciting opportunity to leverage your expertise in a challenging and rewarding environment, working within a company committed to innovation and scientific excellence. The hybrid work model offers a balance between collaborative office-based work and focused remote productivity, supporting a healthy work-life integration for our valued team members in the Pietermaritzburg area.

Key Responsibilities

• Oversee and manage all aspects of assigned clinical trials, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.
• Conduct site initiation visits, monitoring visits, and close-out visits to ensure data integrity, patient safety, and protocol compliance.
• Train and mentor junior research staff, providing guidance and support to ensure consistent performance and development.
• Develop and maintain strong relationships with investigators, site staff, and internal project teams.
• Prepare and present study progress reports, identifying and resolving potential issues and risks in a timely manner.
• Manage trial documentation, including Investigator Site Files (ISFs) and Essential Documents, ensuring accuracy and completeness.
• Collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs, to ensure efficient trial execution.
• Participate in the development and review of clinical trial protocols, informed consent forms, and other essential study documents.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related discipline.
• A Master's degree is a plus.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
• In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory frameworks.
• Proven experience in monitoring clinical trials, including site initiation, routine monitoring, and close-out activities.
• Excellent understanding of clinical trial processes, from protocol development to database lock.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Exceptional written and verbal communication skills, with the ability to effectively interact with diverse stakeholders.
• Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Ability to work independently and as part of a collaborative team, managing multiple priorities effectively.

Benefits

• Competitive annual salary package.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and holiday schedule.
• Opportunities for professional development and continuous learning through workshops and conferences.
• Retirement savings plan with company matching contributions.
• Access to state-of-the-art research facilities and cutting-edge technologies.
• Employee assistance program providing confidential counseling and support services.
• Potential for career advancement within a growing pharmaceutical organization.