Senior Clinical Research Associate (CRA)

Placements24; Kimberley; Hybrid; CAD 56,000 - 77,000; Full time

Benefits offered by this job

Health insurance

Retirement annuity

Bonuses

Professional development

Job summary

Placements24 in Kimberley, SA, seeks an experienced Senior Clinical Research Associate to oversee trials at investigator sites, ensure protocol and GCP compliance, and maintain trial data integrity in a hybrid role with on-site visits and remote tasks.

You will monitor sites, verify data, manage recruitment, and train site personnel while collaborating with sponsors and study teams to drive trial progress.

Qualifications

• 4+ years of experience as a Clinical Research Associate or similar role.
• Thorough understanding of ICH-GCP and regulatory requirements.
• Proven site monitoring and documentation experience.
• Strong communication and organizational skills; travel to sites required.

Responsibilities

• Conduct site initiation, monitoring and close-out visits per SOPs.
• Verify data against source documents and CRFs for quality control.
• Manage subject recruitment and retention at investigator sites.
• Ensure regulatory compliance and study protocol adherence.
• Build relationships with investigators and site staff.
• Oversee investigational product accountability and dispensing records.
• Provide training to site personnel on study procedures.
• Prepare monitoring visit reports promptly.
• Raise issues and risks to CTM and stakeholders as needed.
• Participate in study team meetings to support trial success.

Skills

Communication skills

Organization

Problem-solving

Travel readiness

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related healthcare field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a distinguished pharmaceutical company committed to advancing patient care through innovative research, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dedicated clinical operations team in Kimberley, Northern Cape . This role is vital for overseeing and managing clinical trials at investigator sites, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. You will be instrumental in maintaining the integrity and quality of trial data and contributing to the successful completion of clinical development programs. This hybrid role balances essential on-site site visits with remote administrative tasks, offering flexibility within Kimberley, Northern Cape .

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits according to study protocols and standard operating procedures (SOPs).
• Ensure the quality and integrity of clinical trial data by verifying source documents against case report forms (CRFs).
• Monitor subject recruitment and retention efforts at investigator sites.
• Ensure compliance with all applicable regulatory requirements, GCP, and study protocols.
• Build and maintain strong relationships with investigators, site staff, and study sponsors.
• Manage investigational product accountability and dispensing records.
• Oversee site readiness and provide training to site personnel on study-specific procedures.
• Prepare and present monitoring visit reports in a timely manner.
• Identify and elevate potential issues, risks, and discrepancies to the Clinical Trial Manager and other relevant stakeholders.
• Participate in study team meetings and contribute to the overall success of clinical trials.

Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
• Minimum of 4 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
• Thorough understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements.
• Proven experience in conducting site monitoring visits and documenting findings.
• Excellent understanding of medical terminology and clinical trial documentation.
• Strong organizational, time management, and problem-solving skills.
• Exceptional interpersonal and communication skills, with the ability to build rapport with diverse stakeholders.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to investigator sites as required.
• Self-motivated with the ability to work independently and as part of a remote or hybrid team.

Benefits

Our client offers a competitive salary package commensurate with experience, along with comprehensive benefits including health insurance, a retirement annuity, and performance-based bonuses. Opportunities for professional development, ongoing training, and career advancement within the clinical research field are provided. Employees also receive generous paid time off and access to wellness programs. This role in Kimberley, Northern Cape , offers a stimulating career path within a supportive and innovative pharmaceutical research environment.