Senior Clinical Research Associate (Pharma)

Placements24; Benoni; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid vacation

Job summary

Placements24 in Benoni, Gauteng, is seeking a Senior Clinical Research Associate to lead and monitor clinical trials ensuring data integrity, patient safety, and protocol compliance. The role requires extensive travel to investigative sites and collaboration with site staff and internal teams.

Ideal candidates have a Bachelor’s in life sciences or related field, 5+ years as a CRA, and strong CTMS/EDC experience, with excellent communication and organizational skills.

Qualifications

• Bachelor's degree in a life science, nursing, pharmacy or related discipline.
• Minimum 5 years as a Clinical Research Associate with monitoring multiple trials.
• Strong knowledge of GCP/ICH and regulatory requirements.
• Proven ability to manage site relationships and ensure high-quality data.
• Excellent organizational, time management and communication skills.

Responsibilities

• Identify, evaluate and select clinical trial sites.
• Initiate, monitor and close-out sites per protocol and SOPs.
• Ensure accurate data collection and timely query resolution.
• Monitor patient safety and regulatory compliance.
• Manage investigational product accountability at sites.
• Prepare site monitoring reports and participate in team meetings.

Skills

Site management

GCP/ICH knowledge

Data quality focus

Excellent communication

Travel readiness

Education

Bachelor's degree in life sciences, nursing, pharmacy, or related field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading global pharmaceutical company, is actively seeking an experienced Senior Clinical Research Associate (CRA) to enhance their clinical operations team based in Benoni, Gauteng . This crucial role involves managing and monitoring clinical trials to ensure data integrity, patient safety, and adherence to study protocols and regulatory requirements. The Senior CRA will play a pivotal part in the successful execution of clinical studies, contributing to the development of innovative therapies. We are dedicated to advancing medical science through rigorous and ethical clinical research, and your expertise will be vital to our mission. This is a challenging yet rewarding opportunity to make a tangible impact on patient lives within a dynamic and collaborative environment in Benoni, Gauteng . The role requires extensive travel to investigative sites and close collaboration with site staff and internal project teams within the pharmaceutical research sphere.

Key Responsibilities

• Identify, evaluate, and select potential clinical trial sites.
• Initiate, monitor, and close-out clinical trial sites according to study protocols, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
• Ensure accurate and timely collection of clinical data, including source data verification and query resolution.
• Monitor patient safety and compliance with study procedures.
• Manage study supplies and investigational product accountability at sites.
• Build and maintain positive relationships with investigators, site staff, and ethics committees.
• Prepare site monitoring reports and participate in regular team meetings.
• Ensure compliance with all applicable regulatory requirements (e.g., SAHPRA, FDA, EMA).
• Assist in the development of study-related documents, such as protocols and Case Report Forms (CRFs).
• Train site staff on study-specific procedures and GCP.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related discipline.
• Minimum of 5 years of experience as a Clinical Research Associate, with demonstrated experience in monitoring multiple clinical trials.
• Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven ability to manage site relationships effectively and ensure high-quality data collection.
• Strong organizational and time management skills, with the ability to prioritize tasks effectively.
• Excellent written and verbal communication skills.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel frequently to clinical trial sites (approximately 60-70%).
• Ability to work independently and as part of a collaborative team.
• Problem-solving skills and attention to detail.

Benefits

Our client offers a highly competitive compensation package, including a substantial annual salary and performance-based bonuses, commensurate with your experience and contributions to clinical research. The comprehensive benefits program includes robust health insurance, retirement savings plans, and generous paid vacation and sick leave. We are committed to the professional development of our employees, providing opportunities for advanced training, certification, and attendance at industry conferences. Join a supportive and dynamic team dedicated to advancing pharmaceutical innovation and improving patient health in Benoni, Gauteng . This is an exceptional opportunity to grow your career as a Senior CRA within a leading pharmaceutical organization.