Clinical Research Associate - Pharmaceutical

About the Role

Our client is seeking a diligent and experienced Clinical Research Associate (CRA) to oversee clinical trial activities in the Richards Bay region. This pivotal role ensures that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines. You will be instrumental in managing relationships with investigational sites, monitoring patient data, and ensuring the safety and rights of trial participants. This position offers an excellent opportunity to contribute to life-changing pharmaceutical research within a supportive team environment.

Key Responsibilities

• Monitor clinical trial sites to ensure compliance with protocols, SOPs, and GCP guidelines.
• Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
• Manage communication between investigational sites and the sponsor, addressing queries and resolving issues promptly.
• Conduct site initiation visits, routine monitoring visits, and site closure visits.
• Ensure proper investigational product accountability and handling at study sites.
• Prepare monitoring reports and maintain accurate and complete trial master files (TMF).

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
• Minimum of 3 years of experience as a Clinical Research Associate or equivalent role in the pharmaceutical industry.
• Thorough understanding of GCP , ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in site monitoring and data management.
• Excellent organizational, communication, and interpersonal skills.
• Willingness to travel regularly within the Richards Bay area and surrounding regions to monitor clinical trial sites.

Benefits

• Competitive salary and travel allowances.
• Comprehensive health, dental, and vision insurance plans.
• Opportunities for career advancement within clinical operations.
• Paid training and professional development support.
• A collaborative and ethical work environment committed to advancing medical research.
• Company-provided laptop and mobile phone for work-related communications.

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