Clinical Research Associate (CRA) II

Placements24; Klerksdorp; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Health benefits

Bonus program

Hybrid work arrangement

Career development

Job summary

Placements24 is seeking an experienced Clinical Research Associate II to oversee hybrid on-site and remote monitoring in Klerksdorp, North West. You will manage multiple trials, ensure data integrity, and uphold regulatory standards across studies.

The role requires 3–5 years of CRA experience, solid GCP knowledge, and proficiency with CTMS/EDC systems. Travel to sites is expected; a strong documentation mindset is essential.

Qualifications

• Bachelor's degree or higher in a life science, nursing, or related field.
• Minimum 3–5 years as a Clinical Research Associate.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Proven site monitoring experience and comprehensive site visit capability.
• Familiarity with CTMS and EDC systems; excellent documentation skills.

Responsibilities

• Conduct pre-study, initiation, interim monitoring, and close-out visits at clinical trial sites.
• Ensure accurate SDV and review of study documentation for quality and integrity.
• Monitor patient safety and ensure adherence to protocol and regulatory requirements.
• Build relationships with investigators, site staff, and internal teams to support trials.
• Identify and document protocol deviations and adverse events; manage monitoring reports.

Skills

Site monitoring

GCP knowledge

CTMS experience

EDC experience

Regulatory compliance

Communication skills

Education

Bachelor's degree in life science, nursing, or related field

Tools

CTMS

EDC

Job description

About the Role

Our client, a global biopharmaceutical company dedicated to advancing medical breakthroughs, is seeking an experienced Clinical Research Associate (CRA) II to join their expanding team in Klerksdorp, North West . This hybrid role will involve a mix of on-site monitoring of clinical trial sites and remote oversight, ensuring the highest standards of data integrity, patient safety, and regulatory compliance. The CRA II will be instrumental in managing multiple clinical trials across various therapeutic areas, fostering strong relationships with investigators and site staff, and ensuring adherence to study protocols. This is an exciting opportunity to contribute to the development of innovative treatments and make a tangible impact on patient lives.

Key Responsibilities

• Conduct pre-study, initiation, interim monitoring, and close-out visits at clinical trial sites according to protocol and regulatory requirements.
• Ensure accurate, complete, and timely source data verification (SDV) and review of study documentation.
• Monitor patient safety and ensure adherence to protocol, GCP, and all applicable regulations.
• Build and maintain strong working relationships with investigators, site staff, and internal project teams.
• Identify, document, and track protocol deviations and adverse events.
• Prepare and present monitoring reports and follow up on action items.
• Manage clinical trial supplies and study-related materials at the site level.
• Ensure timely data entry and query resolution by site staff.
• Contribute to the development of study-related documents, such as protocols and case report forms (CRFs).
• Participate in investigator meetings and provide training to site personnel as needed.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3-5 years of experience as a Clinical Research Associate.
• Strong knowledge of ICH-Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Proven experience in site monitoring, including conducting comprehensive site visits.
• Excellent understanding of clinical trial processes and documentation.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Exceptional communication, interpersonal, and organizational skills.
• Ability to manage multiple priorities and work effectively under pressure.
• Willingness to travel extensively to clinical sites as required.
• Problem-solving skills with a meticulous attention to detail.

Benefits

Our client offers a competitive salary, comprehensive health and wellness benefits, and a generous bonus program. We provide extensive opportunities for professional growth, including advanced training and career progression pathways. This hybrid role offers the flexibility to work remotely for a portion of your week, balancing on-site responsibilities with personal needs. The position is based in the Klerksdorp, North West region, providing access to diverse clinical trial sites. Join a collaborative and supportive team dedicated to scientific advancement.