Senior Clinical Research Associate - Oncology Trials

Placements24; Sandton; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive pay

Health insurance

Paid time off

Professional development

Travel reimbursements

Retirement plan

Life insurance

Job summary

Placements24 is seeking a Senior Clinical Research Associate (CRA) to join our team in Sandton, Gauteng. The candidate will lead site monitoring in oncology trials, ensure data integrity, and uphold regulatory standards.

Responsibilities include site visits, verification of CRFs, and mentoring site staff. The role requires strong communication, organizational skills, and willingness to travel up to 50% within Sandton and surrounding areas.

Qualifications

• Bachelor's degree in life sciences, nursing, or related healthcare field.
• Minimum 5 years of CRA experience with oncology focus.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.

Responsibilities

• Conduct site qualification, initiation, interim monitoring, and close-out visits.
• Ensure data integrity by verifying source documentation against CRFs.
• Monitor adherence to protocols, SOPs, and GCP guidelines.
• Identify and resolve site-level issues and deviations promptly.
• Train investigators and site staff on study procedures.
• Manage site relationships and communications with investigators and staff.
• Prepare monitoring visit reports and track follow-ups.
• Ensure timely submission of study documents.
• Contribute to protocol development and risk-based monitoring strategies.

Skills

Communication skills

Organizational skills

Travel willingness

Clinical trial knowledge

Education

Bachelor's degree in life sciences or nursing

Tools

EDC systems

Study protocol software

Job description

About the Role

Our client is a globally recognized Contract Research Organization (CRO) specializing in supporting innovative clinical trials. We are seeking an experienced Senior Clinical Research Associate (CRA) to join our dynamic team in Sandton, Gauteng. This role is crucial for ensuring the successful execution of clinical studies, particularly in the challenging and vital field of oncology research. You will be responsible for site monitoring, data integrity, and adherence to protocol and regulatory requirements. This position offers an exceptional opportunity to advance your career in clinical research, contribute to groundbreaking cancer therapies, and work within a supportive and professional environment based in Sandton, Gauteng.

Key Responsibilities

• Conduct site qualification, initiation, interim monitoring, and close-out visits for clinical trial sites.
• Ensure the quality and integrity of data collected during clinical trials by verifying source documentation against case report forms (CRFs).
• Monitor compliance with study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
• Identify, resolve, and elevate site-level issues and deviations in a timely manner.
• Train and mentor investigators and site staff on study-specific procedures and requirements.
• Manage site relationships and foster strong communication channels with investigators, study coordinators, and site personnel.
• Prepare comprehensive monitoring visit reports and follow up on action items.
• Ensure accurate and timely submission of study-related documents.
• Participate in the development and review of clinical study protocols and other relevant study documents.
• Contribute to risk-based monitoring strategies and implementation.

Requirements

• Bachelor's degree in a life science, nursing, or a related healthcare field.
• Minimum of 5 years of experience as a Clinical Research Associate, with a significant portion focused on oncology clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in conducting various types of monitoring visits (qualification, initiation, routine, close-out).
• Strong understanding of clinical trial processes and terminology, particularly in oncology.
• Excellent organizational, time management, and prioritization skills.
• Exceptional interpersonal and communication skills, with the ability to build rapport with site staff.
• Proficiency in using clinical data management systems (EDC) and other clinical trial software.
• Ability to travel to clinical sites as required (up to 50% in some cases) within Sandton, Gauteng and surrounding areas.
• Valid driver's license and access to a reliable vehicle.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and holiday schedule.
• Opportunities for professional development, training, and career progression within a leading CRO.
• Per diem and travel expense reimbursement for site visits.
• A supportive and collaborative team environment focused on advancing medical research.
• Retirement savings plan.
• Life insurance coverage.