Clinical Research Associate II - Cardiovascular

Placements24; Cape Town; Hybrid; ZAR 540,000 - 860,000; Full time

Benefits offered by this job

Health insurance

Dental and Vision insurance

Retirement plan

Paid time off

Job summary

Placements24 is seeking a diligent Clinical Research Associate II (CRA II) for a hybrid role in Cape Town, Western Cape. You will monitor trial sites to ensure data integrity, patient safety, and protocol compliance, with travel 40–60%.

The ideal candidate has a life-science degree, 3+ years as a CRA, and experience in cardiovascular trials, using EDC/CTMS systems, and strong communication skills.

Qualifications

• Bachelor’s degree in a life science, nursing, or related field; Master’s degree a plus.
• Minimum 3 years as a CRA or equivalent in pharma/biotech.
• Experience monitoring clinical trials, preferably cardiovascular.

Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits.
• Verify data via source data verification.
• Ensure adherence to GCP, protocols, and regulatory requirements.
• Manage data queries promptly and communicate findings.
• Build relationships with investigators and sites; communicate with sponsors.
• Prepare monitoring visit reports with findings and actions.
• Identify site-specific issues and risks to patient safety and data quality.
• Facilitate regulatory audits and sponsor inspections as needed.
• Contribute to study documents and training site staff.

Skills

CRA monitoring

Regulatory compliance

Data integrity

Site communication

EDC systems

CTMS

Travel readiness

Team player

Education

Bachelor’s degree in life science/nursing/related field

Master’s degree (a plus)

Tools

EDC

CTMS

Job description

About the Role

Our client, a rapidly growing pharmaceutical company, is seeking a diligent and organized Clinical Research Associate II (CRA II) to join their team. This role is crucial for the successful execution of clinical trials focused on groundbreaking cardiovascular treatments. You will be responsible for monitoring clinical trial sites to ensure data integrity, patient safety, and adherence to protocols and regulatory standards. This is a hybrid position, offering a blend of remote work flexibility and essential on-site engagement at clinical trial locations within the Cape Town, Western Cape, ZA region. The ideal candidate will possess a strong understanding of clinical trial processes, excellent communication skills, and a commitment to upholding the highest standards of ethical research conduct. You will play a vital role in advancing therapies that significantly improve the lives of patients suffering from cardiovascular diseases, contributing directly to the company's mission of innovation and patient care.

Key Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits for clinical trial sites.
• Verify the accuracy, completeness, and integrity of clinical trial data through source document verification.
• Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements.
• Manage and resolve data queries in a timely manner.
• Build and maintain positive working relationships with investigators, site staff, and study sponsors.
• Prepare and present monitoring visit reports, highlighting findings and action items.
• Identify, track, and help resolve site-specific issues and risks to ensure patient safety and data quality.
• Facilitate regulatory audits and sponsor inspections as required.
• Contribute to the development of study-related documents, such as protocols and case report forms (CRFs).
• Provide training and ongoing support to site personnel regarding study procedures.

Requirements

• Bachelor's degree in a life science, nursing, or related field. A Master's degree is a plus.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or equivalent role in the pharmaceutical or biotech industry.
• Proven experience in monitoring clinical trials, preferably in the **cardiovascular** therapeutic area.
• Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
• Excellent organizational and time management skills, with the ability to manage multiple sites and priorities effectively.
• Strong verbal and written communication skills, with the ability to communicate complex information clearly.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to clinical trial sites as needed (estimated 40-60% travel).
• Must be able to work independently and as part of a team.
• Detail-oriented with a commitment to quality and patient safety.

Benefits

• Our client offers a competitive salary package, commensurate with experience.
• Employees receive comprehensive health, dental, and vision insurance.
• A retirement savings plan with company contributions is available.
• Opportunities for professional development, including advanced training and certifications, are provided.
• Paid time off, including vacation, sick leave, and public holidays, is granted.
• A travel expense reimbursement policy is in place for site visits.
• This hybrid role offers the flexibility to work from home for a portion of the week, balancing remote work with necessary on-site responsibilities in Cape Town, Western Cape, ZA.
• Potential for career advancement within the organization exists for high performers.