Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Vereeniging; Hybrid; ZAR 420,000 - 660,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Paid time off

Professional development

Retirement plan

Career progression

Job summary

Placements24 in Vereeniging, Gauteng, seeks an experienced Clinical Research Associate to monitor clinical sites and ensure protocol compliance. The role focuses on data integrity, regulatory adherence, and trial documentation, with travel to sites as needed.

The successful candidate will hold a life science degree and have at least 3 years of CRA experience in pharma or biotech trials, with strong communication and organizational skills.

Qualifications

• Bachelor’s degree in life science, nursing or related field.
• Minimum 3 years of CRA experience in pharmaceutical or biotech trials.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Experience in site monitoring, data review and query resolution.
• Proficient with EDClTMS and capable of travel to sites.

Responsibilities

• Conduct site visits (initiation, monitoring, close-out) to assess study conduct and compliance.
• Ensure adherence to GCP, protocol requirements and regulations.
• Verify data accuracy by reviewing source documents and CRFs.
• Manage essential trial documents and keep them up-to-date.
• Communicate with investigators and site staff to resolve data queries and issues.
• Monitor patient safety and report adverse events timely.
• Oversee investigational product handling at sites and train staff.

Skills

GCP knowledge

ICH guidelines

Data review

CTMS

EDC systems

Travel willingness

Education

Bachelor’s degree in life science, nursing or related field

Tools

CTMS software

EDC software

Job description

About the Role

Our client, a dynamic pharmaceutical company committed to advancing medical research, is seeking a diligent and experienced Clinical Research Associate (CRA) to join their team in Vereeniging, Gauteng . This role is crucial for the successful execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and data integrity. You will be responsible for monitoring clinical trial sites, managing patient data, and ensuring the safety of trial participants. The ideal candidate possesses strong organizational skills, excellent communication abilities, and a thorough understanding of clinical trial processes and regulations. This is a significant opportunity to contribute to groundbreaking medical research and patient well-being within the pharmaceutical sector, based in the thriving region of Vereeniging.

Key Responsibilities

• Conduct site visits (initiation, monitoring, and close-out) to assess study conduct and compliance.
• Ensure adherence to Good Clinical Practice (GCP), protocol requirements, and all applicable regulations.
• Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and case report forms (CRFs).
• Manage and maintain essential trial documents, ensuring they are up-to-date and readily accessible.
• Communicate effectively with investigators, site staff, and internal study teams to resolve data queries and address issues.
• Monitor patient safety and ensure timely reporting of adverse events.
• Oversee the management of investigational product at trial sites.
• Train and support site personnel on study-specific procedures and requirements.
• Prepare site monitoring reports and document all study-related activities.
• Contribute to the development of study protocols and other essential documents as needed.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) in pharmaceutical or biotechnology clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in site monitoring, data review, and query resolution.
• Strong understanding of clinical trial processes, from site selection to trial close-out.
• Excellent organizational and time management skills, with the ability to manage multiple priorities.
• Exceptional written and verbal communication skills.
• Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to clinical trial sites as required.
• Detail-oriented with a strong commitment to data accuracy and patient safety.
• Problem-solving skills and the ability to work independently and as part of a team.
• Relevant certifications (e.g., ACRP, SoCRA) are a plus.

Benefits

• Our client offers a competitive salary, benchmarked against industry standards, and includes performance-related incentives.
• Comprehensive health coverage, including medical, dental, and vision insurance, is provided.
• Employees receive generous paid time off, including vacation, sick leave, and public holidays.
• Opportunities for professional development, such as specialized training programs and attendance at industry conferences, are available.
• A retirement savings plan with employer matching is part of the benefits package.
• The role offers a dynamic work environment in Vereeniging, where you can contribute to significant clinical research advancements.
• Our client values employee growth and provides clear career progression paths for CRAs.