Clinical Research Associate (Pharmaceutical Company) at Sigma Consult

About Our Client:

Our client is a leading pharmaceutical company based in Lagos, Nigeria, dedicated to conducting clinical research to develop new therapies and improve patient care. With a commitment to innovation and excellence, our client collaborates with healthcare professionals and research institutions to advance medical science and bring new treatments to market.

Role Summary:

As a Clinical Research Associate (CRA) at our client's pharmaceutical company, you will be responsible for monitoring clinical trials and ensuring compliance with protocol, regulatory requirements, and good clinical practice (GCP) guidelines. You will play a crucial role in supporting the successful execution of clinical research studies and contributing to the development of new drugs and therapies.

Responsibilities:

• Conduct pre-study site evaluations and initiate clinical trial sites, ensuring compliance with protocol, regulatory requirements, and GCP guidelines.
• Perform site initiation, interim monitoring, and close-out visits according to the study monitoring plan, ensuring the integrity and quality of clinical trial data.
• Review study documents, including protocols, investigator brochures, and informed consent forms, to ensure accuracy and completeness.
• Monitor subject recruitment, enrollment, and retention, providing guidance and support to investigators and site staff to meet study timelines and enrollment targets.
• Perform source data verification (SDV) and data review to ensure the accuracy, completeness, and integrity of clinical trial data and source documents.
• Identify and resolve protocol deviations, adverse events, and data discrepancies in a timely manner, escalating issues as necessary to ensure patient safety and data quality.
• Prepare and submit monitoring reports, site visit reports, and other study documentation accurately and on time, following company and regulatory guidelines.
• Maintain study files and documentation, including regulatory documents, investigator agreements, and essential documents, in compliance with regulatory requirements and company SOPs.

Requirements:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field.
• Minimum of 2 years of experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) in the pharmaceutical or biotech industry.
• Knowledge of clinical trial regulations, including ICH-GCP guidelines, FDA regulations, and local regulatory requirements.
• Strong understanding of clinical trial processes, study protocols, and clinical trial documentation.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and collaboratively in a dynamic, fast-paced environment.
• Willingness to travel to clinical trial sites as needed.

Benefits:

• Competitive salary package with opportunities for performance-based bonuses.
• Opportunities for professional development and career advancement.
• Supportive work environment with opportunities for learning and growth.
• Comprehensive benefits package including health insurance and retirement benefits.
• Opportunity to contribute to the development of new therapies and improve patient care through clinical research.