Clinical Research Associate (CRA) - Pharmaceutical Trials

Placements24; LegKraal Gate; Hybride; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Travel allowance

Per diem

Health insurance

Retirement plan

Career development

Hybrid work

Exposure to diverse trials

Résumé du poste

Placements24 is seeking a seasoned Clinical Research Associate to join a leading CRO in Mahikeng, North West. The hybrid role monitors trial sites to ensure protocol, GCP, and ICH compliance while supporting initiation, monitoring, and close-out activities.

You will travel regionally, train site staff, verify SDV data, manage documentation, and collaborate with investigators, sponsors, and project teams to ensure data integrity and patient safety.

Qualifications

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years' CRA or similar clinical research experience.
• Strong understanding of clinical trial processes, GCP, ICH guidelines.
• Experience in site monitoring visits and multi-site management.
• Excellent communication and organizational skills.
• Willingness to travel frequently within the region.
• ACRP or SoCRA certifications are a plus.

Responsabilités

• Perform site initiation, monitoring, and close-out visits in accordance with study protocols and GCP guidelines.
• Verify data via source data verification (SDV).
• Ensure investigational product is handled, dispensed, and accounted for correctly at study sites.
• Train site staff on study protocols and data collection requirements.
• Oversee patient recruitment and retention efforts at assigned sites.
• Manage and maintain study-related documentation at sites, ensuring regulatory compliance.
• Communicate effectively with investigators, site staff, study sponsors, and internal project teams.
• Identify and resolve site-level issues and escalation of critical issues as needed.
• Ensure compliance with all relevant local and international regulations governing clinical trials.
• Prepare visit reports and follow-up on action items in a timely manner.

Connaissances

GCP knowledge

Site monitoring

CTMS

EDC systems

Interpersonal skills

Formation

Bachelor's degree in Life Sciences

Outils

CTMS

EDC

Description du poste

About the Role

Our client, a leading Contract Research Organization (CRO) in the pharmaceutical sector, is seeking a dedicated and experienced Clinical Research Associate (CRA) to join their team. Based in Mahikeng, North West, this hybrid role involves monitoring clinical trial sites to ensure adherence to protocols, regulations, and Good Clinical Practices (GCP). You will be responsible for the initiation, monitoring, and close-out of clinical trial sites, ensuring the quality and integrity of trial data. This is a crucial role in bringing new pharmaceutical therapies to market, contributing directly to patient health outcomes. The ideal candidate will have a strong understanding of clinical trial processes, excellent interpersonal skills, and the ability to manage multiple sites effectively. This position offers significant travel opportunities within the region, balanced with remote work flexibility.

Key Responsibilities

• Perform site initiation, interim monitoring, and close-out visits in accordance with study protocols, SOPs, and GCP guidelines.
• Verify the accuracy, completeness, and consistency of clinical data through source data verification (SDV).
• Ensure investigational product is handled, dispensed, and accounted for correctly at study sites.
• Train site staff on study protocols, procedures, and data collection requirements.
• Oversee patient recruitment and retention efforts at assigned clinical trial sites.
• Manage and maintain study-related documentation at sites, ensuring regulatory compliance.
• Communicate effectively with investigators, site staff, study sponsors, and internal project teams.
• Identify and resolve site-level issues and escalation critical issues as needed.
• Ensure compliance with all relevant local and international regulations governing clinical trials.
• Prepare visit reports and follow-up on action items in a timely manner.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical research role.
• Thorough understanding of clinical trial processes, GCP, ICH guidelines, and regulatory requirements.
• Proven experience in conducting site monitoring visits and managing multiple clinical trial sites.
• Excellent communication, interpersonal, and organizational skills.
• Ability to travel frequently to clinical trial sites within the assigned region.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong attention to detail and ability to ensure data integrity and patient safety.
• Ability to work independently and as part of a remote and on-site team.
• Relevant certifications (e.g., ACRP, SoCRA) are a plus.

Benefits

• Competitive salary package.
• Travel allowance and per diem for site visits.
• Comprehensive health insurance and retirement plan.
• Opportunities for professional development and career progression within a growing CRO.
• Exposure to diverse clinical trials and therapeutic areas.
• Flexible hybrid work arrangement, balancing remote work with on-site requirements in Mahikeng, North West.
• Contribute to the advancement of medical treatments.