Pharmaceutical Clinical Research Associate (CRA)

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

Benefits offered by this job

Competitive salary

Health insurance

Travel reimbursement

Professional development

Team environment

Job summary

Placements24 is seeking a diligent and experienced Pharmaceutical Clinical Research Associate (CRA) to support clinical trial operations in Upington. The CRA will monitor sites to ensure trials are conducted, recorded, and reported per protocol, SOPs, and GCP, maintaining data integrity across the study.

The role requires a Bachelor's degree in a life science or related field and a minimum of 3 years CRA experience in pharma, with strong knowledge of GCP, FDA regulations, and ICH guidelines.

Qualifications

• Bachelor's degree in life science, nursing, or related field.
• Minimum of 3 years' experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
• Thorough understanding of GCP, FDA regulations, and ICH guidelines.
• Experience with EDC and CTMS.

Responsibilities

• Conduct site initiation visits, interim monitoring visits, and close-out visits to ensure protocol compliance.
• Verify the accuracy and completeness of clinical trial data by reviewing source documents against the CRFs.
• Ensure investigational products are handled, stored, dispensed, and accounted for correctly at trial sites.
• Train and support site personnel on protocol requirements, study procedures, and data management.
• Build and maintain relationships with investigators and site staff to facilitate smooth trial conduct.
• Prepare monitoring visit reports and follow up on action items with site staff and the study team.

Skills

GCP knowledge

FDA regulations

ICH guidelines

EDC systems

CTMS

Monitoring visits

Data verification

Organizational skills

Communication skills

Education

Bachelor's degree in life science or related field

Tools

EDC systems

CTMS

Job description

About the Role

Our client is seeking a diligent and experienced Pharmaceutical Clinical Research Associate (CRA) to support their clinical trial operations in the Upington region. As a CRA, you will be responsible for monitoring clinical trial sites to ensure that trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and Good Clinical Practices (GCP). Your role is vital in ensuring the integrity and accuracy of clinical trial data, which is essential for the development of new medicines. This is an excellent opportunity for a proactive individual passionate about advancing medical research within the pharmaceutical sector.

Key Responsibilities

• Conduct site initiation visits, interim monitoring visits, and close-out visits to ensure protocol compliance.
• Verify the accuracy and completeness of clinical trial data by reviewing source documents against the case report forms (CRFs).
• Ensure that investigational products are handled, stored, dispensed, and accounted for correctly at the trial sites.
• Train and support site personnel on protocol requirements, study procedures, and data management.
• Build and maintain positive relationships with investigators and site staff to facilitate smooth trial conduct.
• Prepare comprehensive monitoring visit reports and follow up on action items with site staff and the study team.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimumof3years of experienceas a Clinical Research Associate (CRA) in the pharmaceutical industry.
• Thorough understanding of Good Clinical Practices (GCP), FDA regulations, and ICH guidelines.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent organizational, communication, and interpersonal skills, with strong attention to detail.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance coverage.
• Travel reimbursement and per diem for site visits.
• Opportunities for professional development and career growth in clinical research.
• A collaborative and supportive team environment focused on advancing healthcare.