Clinical Research Associate (CRA)

Placements24; Stellenbosch; Hybrid; ZAR 540,000 - 780,000; Full time

Benefits offered by this job

Hybrid work model

Health insurance

Professional development

Job summary

Placements24 is seeking an experienced Clinical Research Associate to cover the Paarl, Western Cape region in a hybrid role. You will monitor clinical trial sites, ensure protocol/SOP/GCP compliance, and oversee data review and reporting, collaborating with investigators and internal teams to ensure data integrity.

The role requires 3+ years of CRA experience, a life science-related degree, and proficiency with CTMS/EDC.

Qualifications

• Bachelor’s degree in a life science, nursing, pharmacy, or a related scientific discipline.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or equivalent role.
• Thorough understanding of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Experience in performing site monitoring visits (initiation, routine, close-out).
• Strong data verification and query resolution skills.
• Excellent written and verbal communication abilities.

Responsibilities

• Perform site initiation, routine monitoring, and site close-out visits according to the Monitoring Plan.
• Ensure compliance with study protocols, SOPs, GCP, ICH guidelines, and regulatory requirements.
• Verify data accuracy through SDV and ensure data quality.
• Manage study supplies and investigator site accountability.
• Build relationships with investigators, site staff, and sponsors.
• Identify and resolve site-related issues promptly.
• Prepare monitoring visit reports for study team and sponsors.
• Oversee recruitment at study sites and monitor subject progress.
• Report SAEs and protocol deviations in a timely manner.
• Participate in investigator meetings and trainings.

Skills

Site monitoring

GCP knowledge

Regulatory compliance

Communication skills

Organizational skills

Education

Bachelor’s degree in life science/nursing/pharmacy or related

Tools

CTMS

EDC

Job description

About the Role

Our client, a leading Contract Research Organization (CRO) dedicated to advancing global health through clinical trials, is seeking a diligent and experienced Clinical Research Associate (CRA) to join their team covering the Paarl, Western Cape region. This hybrid role requires a blend of on-site site management activities and remote responsibilities, including data review and reporting. You will be responsible for monitoring clinical trial sites, ensuring compliance with protocols, GCP, and regulatory requirements, and managing all aspects of site-level trial conduct. Your primary goal will be to ensure the quality, integrity, and timely completion of clinical trial data. This position offers the opportunity to work on diverse therapeutic areas and collaborate with research sites, investigators, and internal study teams. The ideal candidate possesses strong organizational skills, excellent communication abilities, and a thorough understanding of clinical trial processes. You will play a vital role in bringing new therapies to patients by ensuring the accuracy and reliability of clinical trial data generated at your assigned sites.

Key Responsibilities

• Perform site initiation, routine monitoring, and close-out visits for clinical trial sites according to the Clinical Monitoring Plan.
• Ensure compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
• Manage study supplies and investigational product accountability at study sites.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify, document, and resolve site-related issues and discrepancies in a timely manner.
• Prepare and present monitoring visit reports to the study team and sponsors.
• Oversee recruitment efforts at study sites and monitor subject progress.
• Ensure timely reporting of Serious Adverse Events (SAEs) and protocol deviations.
• Participate in investigator meetings and training sessions.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related scientific discipline.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or equivalent role.
• Thorough understanding of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Demonstrated experience in performing site monitoring visits, including initiation, routine, and close-out activities.
• Excellent skills in source data verification and query resolution.
• Strong organizational and time management abilities.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent written and verbal communication skills.
• Ability to work effectively independently and within a hybrid work model, managing both field visits and remote tasks.
• A valid driver's license and access to a reliable vehicle.

Benefits

• Competitive salary package commensurate with experience and qualifications.
• Hybrid work model offering a balance between field and remote work.
• Opportunities to contribute to groundbreaking clinical research across various therapeutic areas.
• Professional development and training programs to enhance your career.
• Comprehensive health insurance and employee wellness programs.

Travel allowance and reimbursement for expenses incurred during site visits.

A supportive team environment with experienced clinical operations professionals.

The chance to make a significant impact on patient care and the development of new medicines.