Senior Clinical Research Associate (CRA) - Phase II/III Trials

Placements24; Noord-Kaap; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Bonuses

Health insurance

Paid time off

Training programs

Retirement plan

Hybrid work

Travel reimbursements

Career development

Job summary

Placements24 seeks a Senior Clinical Research Associate to join a Kimberley-based clinical ops team in a hybrid role. You will monitor Phase II/III sites, ensure GCP compliance, and maintain data integrity while traveling to study centers as needed.

The ideal candidate has 5+ years of CRA experience in pharma/biotech, with strong skills in CTMS/EDC and investigator relations. You will support regulatory documents, site training, and ISF management to advance therapeutic programs.

Qualifications

• Bachelor's degree in life science, nursing, or related healthcare field.
• Minimum 5 years as a CRA in pharma/biotech with Phase II/III trials.
• Thorough knowledge of ICH-GCP and regulatory requirements.
• Proven experience in site monitoring and multi-site management.

Responsibilities

• Conduct monitoring visits (pre-study to close-out) per protocol and SOPs.
• Ensure data integrity through SDV and regulatory document reviews.
• Manage investigator/site relationships and ensure protocol compliance.
• Prepare monitoring reports and support site selection and initiation.
• Train site staff on procedures and requirements and assist with ISF upkeep.

Skills

Site monitoring

CTMS

EDC systems

GCP compliance

Investigator liaison

Travel readiness

Education

Bachelor's degree in life science/healthcare

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a dynamic pharmaceutical company with a strong focus on innovation, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their dedicated clinical operations team based in Kimberley, Northern Cape . This role is instrumental in ensuring the successful execution of Phase II and III clinical trials, upholding the highest standards of data quality, patient safety, and regulatory compliance. As a Senior CRA, you will be responsible for monitoring clinical trial sites, managing relationships with investigators and site staff, and ensuring adherence to study protocols and Good Clinical Practice (GCP). This hybrid role involves regular on-site visits to study centers, complemented by remote work flexibility. We are looking for a meticulous, proactive, and independent professional with a proven ability to manage complex clinical trials and contribute to the efficient delivery of groundbreaking therapies. Your expertise will be vital in advancing our client's pipeline and bringing new treatments to patients.

Key Responsibilities

• Conduct pre-study, initiation, interim, and close-out monitoring visits for clinical trial sites according to protocol, GCP, and company SOPs.
• Ensure the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV) and review of regulatory documents.
• Manage communication and build strong working relationships with investigators, site staff, and other stakeholders.
• Oversee site compliance with study protocols, regulatory requirements, and ethical standards.
• Identify, track, and resolve site-level issues, escalating significant problems as needed.
• Ensure timely submission of essential documents and study supplies to sites.
• Prepare and present monitoring visit reports promptly and accurately.
• Participate in the recruitment and selection of new clinical trial sites.
• Contribute to the development and review of study-related documents, such as protocols and monitoring plans.
• Maintain accurate and organized study files (e.g., Investigator Site Files - ISFs).
• Provide training and guidance to site personnel on study procedures and requirements.
• Represent the company professionally during site visits and interactions.

Requirements

• Bachelor's degree in a life science, nursing, or related healthcare field.
• Minimum of 5 years of experience as a Clinical Research Associate (CRA) in the pharmaceutical or biotechnology industry, with significant experience in Phase II/III trials.
• Thorough understanding of ICH-GCP guidelines and other relevant regulatory requirements.
• Proven experience in conducting site monitoring visits and managing multiple clinical trial sites.
• Excellent knowledge of clinical trial processes, from site selection to close-out.
• Strong interpersonal, communication, and negotiation skills.
• Exceptional organizational and time management skills, with the ability to prioritize effectively.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and travel regularly to assigned clinical sites.
• Problem-solving skills with a proactive approach to identifying and resolving issues.
• A commitment to patient safety and data integrity.
• Experience in specific therapeutic areas is a plus.

Benefits

• Our client offers a competitive salary, along with performance-based bonuses and potential for career advancement.
• Comprehensive health insurance coverage, including medical, dental, and vision plans, is provided.
• Generous paid time off, encompassing vacation, sick leave, and public holidays, supports a healthy work-life balance.
• Opportunities for professional development include access to training programs, workshops, and industry conferences.
• A company-sponsored retirement savings plan is available.
• The hybrid work model allows for flexibility between home-based work and on-site responsibilities.
• Travel expenses are fully reimbursed.
• The work environment in Kimberley is collaborative and focused on achieving clinical milestones.
• This role provides a critical function in bringing new medicines to market.