Clinical Research Associate II - Infectious Diseases

Placements24; Cape Town; Hybrid; ZAR 540,000 - 900,000; Full time

Benefits offered by this job

Company car or travel allowance

Hybrid work model

Medical and retirement benefits

Generous annual leave

Exposure to cutting-edge infectious-ds

Job summary

Placements24 is seeking a Clinical Research Associate II to join our dynamic development team in Cape Town, blending remote work with essential in-person site monitoring for infectious diseases studies. You will ensure data integrity, regulatory compliance, and timely monitoring visits.

The ideal candidate has a life science degree, at least 3 years of CRA experience, and hands-on experience with EDC/CTMS, ICH-GCP, and strong communication. Travel up to 60% is required.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate, with infectious diseases experience.
• Thorough understanding of ICH-GCP guidelines and local regulatory requirements.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent monitoring and source data verification skills.
• Strong written and verbal communication skills and ability to build rapport with site staff.

Responsibilities

• Conduct site visits (initiation, routine monitoring, close-out) to assess study conduct and regulatory compliance.
• Ensure adherence to Good Clinical Practice (GCP), SOPs, and study protocols.
• Verify the accuracy, completeness, and consistency of clinical data through source document verification.
• Manage communication between study sites, investigators, and the internal study team.
• Oversee drug accountability and temperature logs at investigational sites.
• Train site personnel on study procedures and protocol requirements.
• Prepare and present monitoring visit reports in a timely manner.
• Identify and elevate potential issues or risks to study conduct and data quality.

Skills

Monitoring skills

Written and verbal communication

Travel readiness

Organizational skills

Education

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

Tools

EDC systems

CTMS

Microsoft Office Suite

Job description

About the Role

Our client is seeking a dedicated and experienced Clinical Research Associate II to join their dynamic clinical development team based in Cape Town, Western Cape. This hybrid role offers a blend of remote work flexibility and essential in-person site monitoring activities, contributing to critical studies in infectious diseases. You will play a pivotal role in ensuring the smooth execution of clinical trials, upholding the highest standards of data integrity and regulatory compliance. This position is ideal for a proactive individual passionate about advancing medical research and improving patient outcomes in a challenging therapeutic area. The role requires strong organizational skills and the ability to manage multiple priorities effectively within a structured environment. You will be integral to the success of our clinical research operations.

Key Responsibilities

• Conduct site visits (initiation, routine monitoring, close-out) to assess study conduct and regulatory compliance.
• Ensure adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and study protocols.
• Verify the accuracy, completeness, and consistency of clinical data through source document verification.
• Manage communication between study sites, investigators, and the internal study team.
• Oversee drug accountability and temperature logs at investigational sites.
• Train site personnel on study procedures and protocol requirements.
• Prepare and present monitoring visit reports in a timely manner.
• Identify and elevate potential issues or risks to study conduct and data quality.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate, with demonstrated experience in infectious diseases.
• Thorough understanding of ICH-GCP guidelines and local regulatory requirements.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent monitoring skills, including source document verification.
• Strong written and verbal communication skills, with the ability to build rapport with site staff.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to travel to clinical sites as required (approximately 40-60% travel).
• Detail-oriented with strong organizational and time management abilities.

Benefits

• Competitive salary package.
• Comprehensive medical and retirement benefits.
• Generous annual leave allowance.
• Opportunities for professional development and career advancement.
• Company car or travel allowance.
• Exposure to cutting-edge infectious disease research.
• Hybrid work model offering flexibility.