Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Gqeberha; Hybrid; ZAR 420,000 - 640,000; Full time

Benefits offered by this job

Bonuses

Health insurance

Paid time off

Retirement plan

Professional development

Hybrid work

Travel allowance

Wellness program

Job summary

Placements24 in Port Elizabeth is seeking an experienced Clinical Research Associate (CRA) to join its clinical operations team. The role blends remote work with on-site responsibilities to support the execution of clinical trials while ensuring data integrity and patient safety.

You'll monitor sites, initiate and close trials, ensure adherence to GCP, ICH guidelines, and SOPs, and collaborate with investigators, sponsors, and study teams.

Qualifications

• Minimum 3 years of CRA experience in pharma.
• In-depth knowledge of ICH‑GCP guidelines.
• Experience monitoring trials across therapeutic areas.
• Ability to travel to clinical sites.

Responsibilities

• Conduct site initiation, routine monitoring, and close‑out visits.
• Ensure adherence to protocols, SOPs, and GCP guidelines.
• Verify accuracy and completeness of clinical data.
• Manage site-level investigational product accountability and reconciliation.
• Build and maintain relationships with investigators and site staff.
• Identify and resolve site-related issues and deviations promptly.

Skills

Attention to detail

Communication skills

Organizational skills

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field

Tools

CTMS

EDC

Job description

About the Role

Our client, a dynamic and innovative pharmaceutical company, is seeking an experienced Clinical Research Associate (CRA) to join their growing clinical operations team. This position offers a hybrid work arrangement, allowing for a blend of remote work and on‑site responsibilities, contributing to the successful execution of clinical trials in Port Elizabeth and surrounding areas. You will play a crucial role in ensuring the quality and integrity of clinical trial data, monitoring site performance, and maintaining compliance with protocols and regulatory requirements. This role demands a meticulous individual with a strong understanding of Good Clinical Practice (GCP) and clinical trial management. You will be responsible for site initiation, monitoring, and close‑out activities, fostering positive relationships with investigative sites and ensuring patient safety. This is an excellent opportunity for a dedicated CRA to advance their career within a supportive and progressive pharmaceutical organization, making a tangible difference in bringing new therapies to patients.

Key Responsibilities

• Conduct site initiation, routine monitoring, and close‑out visits for clinical trial sites.
• Ensure adherence to clinical trial protocols, SOPs, and GCP guidelines.
• Verify the accuracy, completeness, and validity of clinical data.
• Manage site‑level investigational product accountability and reconciliation.
• Build and maintain strong relationships with investigators, site staff, and study sponsors.
• Identify and resolve site‑related issues and deviations in a timely manner.
• Prepare and present monitoring visit reports to study management.
• Ensure timely submission of essential regulatory documents.
• Participate in study team meetings and contribute to the overall success of clinical trials.
• Maintain up‑to‑date knowledge of therapeutic areas and clinical trial methodologies.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical industry.
• In-depth knowledge of ICH‑GCP guidelines and regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent organizational, time management, and communication skills.
• Ability to travel to clinical sites as required.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong problem‑solving and decision‑making abilities.
• Ability to work independently and effectively in a hybrid work environment.
• Commitment to patient safety and data integrity.

Benefits

• Competitive salary and performance‑based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Retirement savings plan with company contribution.
• Opportunities for professional development and advanced training.
• Hybrid work flexibility, allowing for remote work and on‑site visits.
• Company car or travel allowance for site visits.
• Supportive team environment and experienced management.
• Chance to contribute to impactful clinical research.
• Employee wellness programs.