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.