Senior Clinical Research Associate (CRA)

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

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Hybrid role

Professional development

Job summary

Placements24 is seeking a Senior Clinical Research Associate to support clinical trials in Gauteng, with hybrid office work in Benoni and significant field monitoring. The role emphasizes data integrity, patient safety, and adherence to protocol and regulatory guidelines.

The ideal candidate has 5+ years of CRA experience, strong GCP knowledge, and the ability to travel to trial sites locally and nationally. Collaboration with project teams and ongoing professional development are encouraged.

Qualifications

• Bachelor's degree in a life science, nursing, pharmacy, or related field.
• Minimum of 5 years of experience as a Clinical Research Associate.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience in site selection, initiation, monitoring, and close-out activities.
• Excellent understanding of clinical trial processes and documentation.
• Strong analytical and problem-solving skills with attention to detail.
• Exceptional communication and organizational skills.
• Ability to travel frequently to Benoni and surrounding areas, plus some national/international travel.
• Certification from a recognized body (ACRP/SoCRA) is a plus.

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits per protocols and GCP.
• Ensure timely data collection, source data verification, and query resolution at sites.
• Monitor patient safety and protocol compliance; report adverse events or deviations.
• Build relationships with investigators, site staff, and sponsors.
• Prepare and present monitoring visit reports with findings and actions.
• Maintain study documentation per regulatory requirements.
• Oversee investigational product management at sites.
• Train and mentor junior CRAs and site personnel.
• Collaborate with project teams including PMs, data managers, and medical monitors.

Skills

Site monitoring

GCP knowledge

ICH guidelines

Communication

Travel readiness

Education

Bachelor's degree in life science/healthcare

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a prominent Contract Research Organization (CRO) specializing in clinical trials, is seeking an experienced Senior Clinical Research Associate (CRA) to join their team. This role is crucial for ensuring the successful execution of clinical trials, adhering strictly to protocols, Good Clinical Practice (GCP), and regulatory guidelines. While the position is primarily hybrid, requiring presence in the Benoni, Gauteng office for essential meetings and training, significant fieldwork will involve monitoring clinical sites. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data integrity and patient safety. This is an excellent opportunity for a dedicated professional to contribute to groundbreaking research and advance the development of new therapies. Join a reputable organization that values scientific integrity and offers a rewarding career path in clinical research.

Key Responsibilities

• Conduct site selection, initiation, interim monitoring, and close-out visits in accordance with study protocols and GCP guidelines.
• Ensure timely and accurate data collection, source document verification, and query resolution at clinical trial sites.
• Monitor patient safety and protocol compliance, identifying and reporting any adverse events or deviations.
• Build and maintain strong relationships with investigators, site staff, and study sponsors.
• Prepare and present monitoring visit reports, summarizing findings and recommending actions.
• Ensure all study-related documentation is maintained accurately and according to regulatory requirements.
• Oversee the management of investigational product at trial sites, ensuring proper storage and accountability.
• Train and mentor junior CRAs and site personnel on study-specific procedures and GCP.
• Collaborate with internal project teams, including project managers, data managers, and medical monitors.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related field.
• Minimum of 5 years of experience as a Clinical Research Associate, with demonstrated success in monitoring clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements for clinical research.
• Proven experience in site selection, initiation, monitoring, and close-out activities.
• Excellent understanding of clinical trial processes and documentation.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Exceptional communication, interpersonal, and organizational skills.
• Ability to travel frequently to clinical trial sites within Benoni, Gauteng and surrounding areas, as well as occasional national or international travel.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and as part of a collaborative team.
• Certification from a recognized professional body (e.g., ACRP, SoCRA) is a plus.

Benefits

• Our client offers a competitive salary, comprehensive health, dental, and vision insurance, a retirement savings plan, and generous paid time off.
• Professional development is a priority, with opportunities for ongoing training, certifications, and career advancement.
• Employees are part of a dynamic and supportive team committed to advancing medical research.
• We provide a stimulating work environment with the flexibility of a hybrid role.
• Our client values work-life balance and employee well-being, offering a supportive and collaborative culture.