About the Role
Our client, a dynamic and growing pharmaceutical company, is seeking a highly motivated Senior Clinical Research Associate (CRA) to join their team in Pietermaritzburg, KwaZulu-Natal, ZA . This role is crucial for the successful execution of clinical trials, ensuring adherence to protocols, regulatory standards, and ethical guidelines. The Senior CRA will be responsible for monitoring clinical trial sites, managing data integrity, and fostering strong relationships with investigators and site staff. This position offers a challenging and rewarding opportunity for experienced CRAs looking to advance their careers within the pharmaceutical industry in the beautiful province of KwaZulu-Natal, ZA , specifically in Pietermaritzburg .
Key Responsibilities
- Conduct site initiation, interim monitoring, and close-out visits for clinical trial sites.
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Manage site performance and identify potential risks or issues, implementing corrective actions as needed.
- Build and maintain strong working relationships with investigators, study coordinators, and site staff.
- Prepare monitoring visit reports and communicate findings to the clinical trial team.
- Ensure timely query resolution and data clarification with study sites.
- Manage essential study documents and ensure proper archiving.
- Participate in the development and review of clinical trial protocols and other study-related documents.
- Stay current with therapeutic area knowledge and clinical research trends.
Requirements
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 4-5 years of progressive experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
- Demonstrated knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience in site monitoring, data review, and regulatory compliance.
- Excellent understanding of clinical trial processes from start to finish.
- Strong organizational, time management, and communication skills.
- Ability to travel to clinical sites as required (approx. 50-60% travel).
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Problem-solving abilities and a proactive approach to identifying and addressing challenges.
- Must be based in or willing to relocate to Pietermaritzburg, KwaZulu-Natal, ZA , with hybrid work flexibility.
Benefits
- Our client provides a competitive compensation package, including a robust salary, performance incentives, and comprehensive benefits such as medical aid and retirement fund contributions.
- We support your professional growth through continuous training programs, access to industry conferences, and opportunities for career advancement within the organization.
- Our client values a healthy work-life balance and offers a supportive and dynamic work environment in Pietermaritzburg, KwaZulu-Natal, ZA .
- You will have the chance to work on exciting and impactful clinical trials that contribute to advancing medical treatments.