Clinical Research Associate - Cardiovascular Studies

Placements24; South Africa; On-site; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Medical aid

Life insurance

Training & development

Collaborative culture

Job summary

Placements24 is seeking a diligent Clinical Research Associate to oversee cardiovascular clinical trials in the Tembisa, Gauteng region. This on-site position involves site initiation, monitoring, and close-out activities, with frequent travel to local clinical sites, ensuring protocol adherence and data integrity.

You will work closely with investigators and site staff, ensuring compliance with GCP/ICH and regulatory requirements, and maintaining rigorous documentation and product

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline.
• Minimum 3 years of CRA experience, preferably in cardiovascular trials.
• Thorough knowledge of GCP, ICH guidelines, and FDA/local regulatory requirements.
• Experience with EDC and CTMS systems.
• Excellent communication and organizational skills.
• Ability to travel frequently to clinical sites in Gauteng region.
• Proficient in Microsoft Office Suite.

Responsibilities

• Conduct site visits (pre-study, initiation, routine monitoring, close-out) for protocol and regulatory compliance.
• Ensure accuracy, completeness and timeliness of trial data via source data verification.
• Manage investigational product accountability and storage/dispensing.
• Identify and escalate study conduct issues and potential risks to the project team.
• Serve as the primary liaison between sponsor and investigative sites.
• Educate site staff on protocol requirements and regulatory compliance.
• Prepare monitoring visit reports and action item follow-up.
• Ensure adherence to GCP, ICH guidelines and local regulations.
• Assist in preparing essential study documents and regulatory submissions.

Skills

Communication

Organizational skills

Travel frequently

Problem solving

Education

Bachelor's degree in Life Sciences / Nursing / Pharmacy

Tools

EDC systems

CTMS

Microsoft Office

Job description

About the Role

Our client, a prominent pharmaceutical company dedicated to advancing cardiovascular medicine, is seeking a diligent and detail-oriented Clinical Research Associate (CRA) to join their operations in Tembisa, Gauteng . This role is essential for overseeing and managing clinical trials related to groundbreaking cardiovascular therapies. The CRA will play a crucial part in ensuring the safety and integrity of trial data, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. You will be instrumental in site initiation, monitoring, and close-out activities, working closely with investigators and site staff to ensure protocol compliance. This is a field-based position, requiring frequent travel to clinical sites within the designated region. The ideal candidate possesses a strong understanding of clinical trial processes and a passion for improving patient outcomes in cardiology. This is a non-remote, on-site opportunity based in Tembisa .

Key Responsibilities

• Conduct site visits (pre-study, initiation, routine monitoring, and close-out) to assess protocol and regulatory compliance.
• Ensure the accuracy, completeness, and timeliness of clinical trial data through source data verification.
• Manage investigational product accountability and ensure proper storage and dispensing.
• Identify, document, and elevate study conduct issues and potential risks to the project team and management.
• Serve as the primary point of contact between the sponsor and investigative sites.
• Educate and train site staff on protocol requirements, study procedures, and regulatory compliance.
• Prepare and present monitoring visit reports and follow up on action items.
• Ensure adherence to all applicable regulatory requirements, including GCP, ICH guidelines, and local regulations.
• Assist in the preparation of essential study documents and regulatory submissions.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
• Minimum of 3 years of experience as a Clinical Research Associate, preferably with a focus on cardiovascular trials.
• Thorough understanding of clinical trial phases, study design, and protocol execution.
• Demonstrated knowledge of GCP, ICH guidelines, and FDA/local regulatory requirements.
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel frequently to clinical sites within the Tembisa, Gauteng area and surrounding regions.
• Strong critical thinking and problem-solving abilities.
• Proficiency in Microsoft Office Suite.
• Commitment to maintaining the highest standards of data integrity and patient safety.

Benefits

• Our client provides a competitive salary package commensurate with experience, along with performance bonuses and a comprehensive benefits scheme including medical aid and life insurance.
• Employees will have access to ongoing training and professional development opportunities to enhance their skills in clinical research.
• The company culture emphasizes collaboration and scientific excellence.
• This role offers the chance to be at the forefront of cardiovascular research, contributing to life-saving advancements.
• Being based in Tembisa allows for convenient access to key healthcare institutions.
• Our client is committed to fostering a supportive work environment for all its employees.