Clinical Research Associate (CRA) - Pharmaceutical

Placements24; Durban; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Medical aid

Retirement contributions

Professional development opportunities

Job summary

Placements24 is seeking a dedicated Clinical Research Associate to join a growing pharmaceutical company. The role is remote within South Africa, with duties spanning site initiation, monitoring, data verification, and regulatory compliance to ensure trial integrity and patient safety.

The ideal candidate holds a life science degree and 3+ years of CRA experience, with strong knowledge of ICH-GCP and CTMS/EDC systems. Travel for site visits is required as needed.

Qualifications

• Bachelor's degree in a life science, nursing, or related healthcare field.
• 3+ years CRA experience in pharma/biotech industry.
• Strong knowledge of ICH-GCP and regulatory requirements.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits per study protocol and regulatory requirements.
• Ensure accurate, complete, and timely data collection through source data verification.
• Verify compliance with GCP, regulatory requirements, and study protocols.
• Build strong relationships with investigators, study coordinators, and site staff.
• Identify, evaluate, and qualify potential trial sites.
• Manage study supplies and investigational product at sites.
• Resolve data discrepancies and timely queries.
• Prepare monitoring visit reports and communicate findings to the team.
• Oversee safety reporting and adverse event processes.
• Assist in regulatory document preparation and submission.
• Archive essential study documents at site level.

Skills

Site monitoring

Data verification

GCP compliance

Regulatory communication

CTMS

EDC systems

Investigator liaison

Documentation

Query resolution

Remote territory management

Education

Bachelor's degree in life science or related field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a dynamic and growing **Pharmaceutical** company, is actively seeking a dedicated Clinical Research Associate (CRA) to join their clinical operations team. This role is crucial for the successful execution of clinical trials, ensuring data integrity, patient safety, and compliance with all regulatory requirements. Although the role is nominally based out of **Durban, KwaZulu-Natal, ZA**, it is a fully remote position, offering flexibility and the opportunity to work from anywhere. The CRA will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, and managing all aspects of site management. The ideal candidate will possess a strong understanding of clinical trial processes, excellent organizational skills, and a commitment to maintaining the highest ethical standards in research. We are looking for a proactive and detail-oriented professional who can effectively manage relationships with investigators and site staff, driving the successful completion of our clinical studies.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits in accordance with study protocols and regulatory requirements.


• Ensure accurate, complete, and timely collection of clinical data through source data verification.


• Verify compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols.


• Build and maintain strong working relationships with investigators, study coordinators, and site staff.


• Identify, evaluate, and qualify potential clinical trial sites.


• Manage study supplies and investigational product at assigned sites.


• Resolve data discrepancies and ensure timely query resolution.


• Prepare monitoring visit reports and communicate findings to the clinical study team.


• Oversee site adherence to safety reporting requirements and adverse event reporting.


• Assist in the preparation and submission of regulatory documents.


• Ensure the proper archiving of essential study documents at the site level.


• Participate in investigator meetings and training sessions.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare field.


• Minimum of 3 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotech industry.


• Strong knowledge of ICH-GCP guidelines and other relevant regulatory requirements.


• Proven experience in site monitoring, data verification, and regulatory compliance.


• Excellent organizational, time management, and problem-solving skills.


• Strong interpersonal and communication skills, with the ability to build rapport with site personnel.


• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.


• Ability to work independently and manage a remote territory effectively.


• Flexibility to travel as required for site visits (though the role is primarily remote).


• Must have the legal right to work in **South Africa**.

Benefits

• medical aid


• retirement contributions


• professional development opportunities

This fully remote position offers a competitive salary and a comprehensive benefits package, including medical aid, retirement contributions, and professional development opportunities. Our client values work-life balance and provides the tools and support necessary for successful remote work. You will have the chance to contribute to impactful clinical trials and advance your career within a supportive and innovative **Pharmaceutical** company. This role offers the advantage of working from anywhere within **South Africa**, contributing to projects managed from **Durban, KwaZulu-Natal, ZA**.