About the Role
Our client is a prominent global pharmaceutical company seeking a dedicated Clinical Research Associate (CRA) to oversee and manage clinical trials conducted across various sites in and around Tembisa, Gauteng . This role is essential for ensuring that clinical research is conducted, recorded, and reported in accordance with the study protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines. The CRA will play a crucial role in patient safety monitoring, data integrity, and timely trial completion, contributing significantly to the development of new pharmaceutical products that address critical healthcare needs. This is a field-based position requiring significant travel within the specified region.
Key Responsibilities
- Conduct site initiation, monitoring, and close-out visits to ensure compliance with protocols and regulations.
- Verify the accuracy, completeness, and consistency of clinical data through source document verification.
- Ensure the safety of trial participants by monitoring adverse events and reporting them as per protocol.
- Maintain effective communication with investigators, site staff, and internal study teams.
- Train and support site personnel on study-related procedures and documentation.
- Manage essential study documents and ensure they are current and properly maintained.
- Identify potential risks and issues at clinical sites and develop and implement corrective action plans.
- Contribute to the development of clinical trial protocols and case report forms.
- Ensure adherence to all applicable regulatory requirements, including local and international GCP standards.
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or a related field.
- A Master's degree is a plus.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role within the pharmaceutical industry.
- Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in performing site monitoring visits and assessing data accuracy.
- Excellent interpersonal, communication, and organizational skills.
- Ability to travel frequently to clinical trial sites within the Gauteng province.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Strong analytical and problem-solving abilities.
- Must be detail-oriented and possess a high level of integrity.
Benefits
- Our client offers a competitive remuneration package commensurate with experience, along with a comprehensive benefits plan that includes medical aid, life insurance, and a retirement fund.
- We provide opportunities for continuous professional development and training, including support for certifications.
- This role offers the chance to work on cutting-edge pharmaceutical research and development projects, making a real difference in patient lives.
- Employees are encouraged to maintain a healthy work-life balance, supported by a collaborative team environment and strong leadership.
- Eligible expenses for travel related to site visits will be reimbursed.
- Join our client's dedicated team and contribute to the future of medicine.