Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; Kempton Park; Sur place; ZAR 600 000 - 900 000; Plein temps

Résumé du poste

Placements24 seeks a dedicated Clinical Research Associate (CRA) to oversee trials in Gauteng, ensuring data integrity, patient safety and regulatory compliance. You will act as a liaison between sponsor and clinical sites, conducting site visits and monitoring activities in Tembisa and surrounding areas.

The ideal candidate has 3–5 years in CRA roles, strong GCP knowledge, and proficiency with EDC/CTMS. Travel to investigational sites will be required as part of the role.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• 3–5 years of direct CRA experience in the pharmaceutical industry.
• Strong understanding of clinical trial processes, GCP, and regulatory requirements.
• Demonstrated experience monitoring clinical trial sites and data verification.
• Excellent organizational and time management skills with ability to manage multiple priorities.
• Exceptional communication, interpersonal, and negotiation skills.
• Proficiency in electronic data capture (EDC) systems and CTMS.
• Ability to travel to investigational sites as required; Tembisa region preferred.

Responsabilités

• Conduct site initiation, monitoring, and close-out visits following study protocols and guidelines.
• Verify accuracy and integrity of data from investigational sites.
• Ensure compliance with GCP, ICH, and local regulations.
• Manage relationships with investigators and site staff; provide training and support.
• Oversee recruitment and informed consent process for participants.
• Monitor drug accountability and investigational product management at sites.
• Prepare and submit monitoring reports with findings and actions.
• Identify and report adverse events and safety concerns promptly.
• Assist in development and finalization of study protocols and documents.

Connaissances

GCP knowledge & regulatory

Site monitoring

Data verification

Organization & time management

Communication & negotiation

EDC/CTMS proficiency

Travel readiness

Formation

Bachelor's degree in life science/nursing/related

Outils

EDC systems

CTMS

Description du poste

About the Role

Our client, a dynamic pharmaceutical company, is actively seeking a dedicated and experienced Clinical Research Associate (CRA) to contribute to groundbreaking clinical trials in Tembisa, Gauteng . This crucial role involves overseeing the conduct of clinical studies at investigational sites, ensuring data integrity, patient safety, and adherence to protocols and regulatory requirements. You will be a key liaison between the sponsor and the clinical sites, playing an essential part in bringing new and vital medications to market.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits in accordance with study protocols and regulatory guidelines.
• Verify the accuracy, completeness, and integrity of clinical data collected at investigational sites.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable local regulations.
• Manage relationships with investigators and site staff, providing training and support as needed.
• Oversee the recruitment and informed consent process for study participants.
• Monitor drug accountability and investigational product management at study sites.
• Prepare and submit monitoring reports, documenting site findings and action items.
• Identify and report adverse events and safety concerns promptly.
• Contribute to the development and finalization of study protocols and other study-related documents.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3-5 years of direct experience as a Clinical Research Associate in the pharmaceutical industry.
• Strong understanding of clinical trial processes, GCP, and regulatory requirements.
• Demonstrated experience in monitoring clinical trial sites and data verification.
• Excellent organizational and time management skills, with the ability to manage multiple priorities effectively.
• Exceptional communication, interpersonal, and negotiation skills.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to investigational sites as required. Previous experience working in the Tembisa, Gauteng region is a benefit.

Benefits

• Join a forward-thinking organization committed to scientific advancement and patient well-being.
• Our client offers a competitive salary, a comprehensive benefits package including medical and retirement plans, opportunities for continuous learning and professional development, and a chance to work on cutting-edge pharmaceutical research.
• Be part of a team that is making a tangible difference in global health.