About the Role Our client, a renowned pharmaceutical company dedicated to advancing cancer therapies, is seeking an experienced Clinical Research Associate (CRA) to join their dedicated team in Cape Town . This role is crucial for the successful execution of clinical trials, ensuring compliance with protocols and regulatory standards. The CRA will be responsible for monitoring study sites, managing data, and ensuring patient safety throughout the trial lifecycle. This is a fantastic opportunity to contribute to life‑saving research and work within a highly professional and supportive environment. You will play a vital role in bringing innovative oncology treatments to patients, making a real difference in the fight against cancer.
Key Responsibilities
- Conduct site initiation, monitoring, and close‑out visits for clinical trials in accordance with Good Clinical Practice (GCP) and study protocols.
- Ensure accurate and timely collection, review, and management of clinical data from study sites.
- Verify compliance with study protocols, regulatory requirements, and institutional guidelines.
- Manage communication between study sites, investigators, and the sponsor.
- Identify, assess, and resolve issues that may impact study conduct or data integrity.
- Train site personnel on study procedures and protocols.
- Prepare monitoring reports and maintain accurate study documentation.
- Contribute to the development and review of study‑related documents, such as protocols and case report forms.
- Ensure patient safety is maintained and any adverse events are reported according to regulatory requirements.
Requirements
- Bachelor's degree in a life science, nursing, or related field.
- Advanced degree preferred.
- Minimum of 3 years of experience as a Clinical Research Associate, preferably with a focus on oncology trials.
- In‑depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven ability to conduct site visits, monitor data, and ensure regulatory compliance.
- Excellent organizational and time management skills.
- Strong problem‑solving and decision‑making abilities.
- Exceptional interpersonal and communication skills, with the ability to build rapport with site staff.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel extensively within the assigned region.
- Must be legally authorized to work in South Africa.
Benefits
- This position offers a competitive annual salary, a comprehensive benefits package including medical aid and retirement fund, and a performance bonus program.
- Our client also provides excellent opportunities for professional development, training, and career progression within the pharmaceutical industry.
- The Cape Town location provides an attractive lifestyle with world‑class amenities and a beautiful natural environment.
- You will be part of a dedicated team committed to excellence in clinical research and patient care.