Clinical Research Associate

Placements24; Willows (CA); On-site; USD 36,000 - 54,000; Full time

Benefits offered by this job

Competitive rate

Travel opportunities

Professional development

Exposure to diverse trials

Job summary

Placements24 seeks a meticulous Clinical Research Associate (CRA) to oversee site monitoring for trials in Welkom, Free State. The role emphasizes data integrity, patient safety, and protocol adherence. You will travel regularly to sites and ensure compliance with ICH-GCP and FDA guidelines.

The ideal candidate holds a life sciences degree, 3–5 years of CRA experience, and strong CTMS/EDC proficiency. Join a prominent pharmaceutical research organization committed to high standards and patient

Qualifications

• Bachelor’s degree in life science, nursing, pharmacy or related discipline.
• 3–5 years of direct CRA experience.
• Strong knowledge of clinical trials, ICH-GCP and regulatory affairs.
• Experience in site monitoring, data verification and regulatory compliance.
• Excellent written and verbal communication skills.
• Proficient in CTMS and EDC systems.
• Able to travel extensively within the region.

Responsibilities

• Conduct site selection, initiation, monitoring and close-out visits per protocols and SOPs.
• Verify data through SDV for accuracy and completeness.
• Monitor patient safety and adverse event reporting per regulations.
• Train site personnel on protocol requirements and data collection.
• Maintain communication between sponsor/CRO and trial sites.
• Ensure regulatory compliance with ICH-GCP, FDA and local guidelines.
• Prepare and submit site monitoring reports timely.
• Identify risks at sites and develop mitigation strategies.
• Oversee investigational product management and supplies at sites.
• Facilitate audits and inspections as required.
• Maintain organized site files and documentation.
• Contribute to successful trials in Welkom, Free State and surrounding areas.

Skills

Site Monitoring

CTMS

EDC

Data Integrity

ICH-GCP

Regulatory Compliance

Travel

Communication

Documentation

Education

Bachelor’s degree in life science

Tools

CTMS software

EDC systems

Job description

About the Role

Our client, a prominent pharmaceutical research organization, is seeking a highly meticulous and experienced Clinical Research Associate (CRA) to join their team in Welkom, Free State . This role is critical for ensuring the successful execution of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. The CRA will be responsible for monitoring clinical trial sites, ensuring data integrity, patient safety, and protocol compliance. This position demands a deep understanding of clinical research processes, excellent organizational skills, and the ability to work autonomously in the field. The opportunity is based in Welkom and requires regular travel to clinical sites across the region.

Key Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits in accordance with clinical trial protocols and standard operating procedures (SOPs).
• Verify the accuracy, completeness, and consistency of clinical data reported by sites through source data verification (SDV).
• Ensure patient safety and adherence to protocol requirements by monitoring adverse events and serious adverse events reporting.
• Train site personnel on protocol requirements, study procedures, and data collection.
• Manage communication between the sponsor/CRO and the clinical trial sites.
• Ensure compliance with all applicable regulatory requirements, including ICH-GCP, FDA regulations, and local health authority guidelines.
• Prepare and submit site monitoring reports in a timely manner.
• Identify potential risks and issues at clinical sites and develop mitigation strategies.
• Oversee the management of investigational product and study supplies at sites.
• Facilitate audits and regulatory inspections as required.
• Maintain accurate and organized site files and documentation.
• Contribute to the overall success of clinical trials conducted in Welkom, Free State and surrounding areas.

Requirements

• A Bachelor's degree in a life science, nursing, pharmacy, or a related discipline.
• Minimum of 3-5 years of direct experience as a Clinical Research Associate.
• Strong knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory affairs.
• Experience in site monitoring, data verification, and regulatory compliance.
• Excellent written and verbal communication skills.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Strong organizational and time management skills, with the ability to prioritize tasks effectively.
• Ability to travel extensively within the Free State region as required by the trial.
• Detail-oriented with a high level of accuracy.
• Problem-solving abilities and a proactive approach to challenges encountered in the field.
• Demonstrated commitment to patient safety and data integrity.

Benefits

• Competitive contract rate commensurate with experience.
• Opportunity to work on diverse and cutting-edge clinical trials.
• Gain exposure to various therapeutic areas and research methodologies.
• Travel opportunities within the Free State .
• Professional development and training opportunities within clinical research.
• A role that contributes directly to advancing medical treatments from Welkom .