About the Role
Our client, a prominent Contract Research Organization (CRO) specializing in oncology clinical trials, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their expanding team. This role is critical for the successful execution of complex clinical studies aimed at bringing life‑saving cancer treatments to market. Based in Richards Bay, KwaZulu‑Natal , the CRA will be responsible for monitoring clinical trial sites to ensure data integrity, patient safety, and adherence to protocols and regulatory requirements. This is an office‑based position requiring frequent travel to investigational sites within the region. You will play a vital role in advancing cutting‑edge therapies and making a significant impact on the lives of cancer patients.
Key Responsibilities
- Perform site qualification, initiation, interim monitoring, and close‑out visits in accordance with clinical trial protocols and GCP guidelines.
- Ensure that study conduct is in compliance with the protocol, regulatory requirements, and company Standard Operating Procedures (SOPs).
- Verify the accuracy, completeness, and integrity of clinical data through source data verification (SDV).
- Train and support site staff on study procedures, protocol requirements, and data collection.
- Build and maintain strong working relationships with investigators, study coordinators, and other site personnel.
- Manage and resolve data discrepancies and outstanding queries in a timely manner.
- Ensure proper storage and management of essential study documents at the investigative sites.
- Report adverse events and safety information according to protocol and regulatory requirements.
- Participate in investigator meetings and training sessions.
- Prepare comprehensive monitoring visit reports and follow up on action items.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
- Minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial monitoring role.
- Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
- Demonstrated experience in monitoring oncology clinical trials is essential.
- Excellent knowledge of medical terminology and clinical trial procedures.
- Proficiency in Electronic Data Capture (EDC) systems and clinical trial management software.
- Exceptional organizational, time management, and problem‑solving skills.
- Strong communication and interpersonal skills, with the ability to build rapport with site staff.
- Willingness and ability to travel frequently (up to 60%) within the assigned region.
- Valid driver's license and a reliable vehicle.
- Ability to work independently and manage multiple priorities effectively.
Benefits
- Competitive salary package.
- Performance‑based bonuses.
- Comprehensive medical and dental coverage.
- Retirement savings plan.
- Generous travel allowances and per diems.
- Paid time off and public holidays.
- Opportunities for professional growth and development within a leading CRO.
- Exposure to innovative oncology treatments.
- Supportive team environment.