Senior Clinical Research Associate (CRA)

Placements24; Queenstown; Hybrid; NZD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive salary with performanceBon

Health insurances

Job summary

Placements24 is seeking an experienced Senior Clinical Research Associate (CRA) to join our expanding team in Queenstown, NZ. You will oversee multiple clinical trial sites, ensure GCP compliance, and support data integrity and patient safety across studies.

The ideal candidate has 5+ years of CRA or related trial management experience, strong communication skills, and CTMS/EDC proficiency. This role offers hybrid work arrangements and opportunities for professional development in a dynamic CRO

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field.
• Minimum 5 years of CRA or similar trial management experience.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience in site monitoring, data verification, and regulatory compliance.
• Excellent organization, time management, and problem-solving skills.
• Strong written and verbal communication with diverse stakeholders.
• Experience with CTMS and EDC systems.
• Willingness to travel to trial sites.
• Detail-oriented and independent worker.

Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close-out visits.
• Ensure adherence to protocols, SOPs, GCP, and regulatory requirements.
• Verify accuracy, completeness, and consistency of data through source data verification.
• Manage site-level trial activities, including patient recruitment, informed consent process, and adverse event reporting.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify and resolve site-specific issues and deviations promptly.
• Prepare and submit accurate monitoring visit reports in a timely manner.
• Oversee the training of site personnel on study protocols and procedures.
• Ensure the proper management and accountability of investigational products and study supplies.
• Contribute to the development of study plans and site selection criteria.

Skills

Site monitoring

GCP compliance

Data verification

CTMS & EDC

Stakeholder communication

Travel readiness

Education

Bachelor's degree in life sciences or related field

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading Contract Research Organization (CRO) dedicated to advancing medical breakthroughs, is seeking an experienced Senior Clinical Research Associate (CRA) to join their expanding team in Queenstown, Eastern Cape . This pivotal role involves overseeing and managing clinical trial sites, ensuring compliance with Good Clinical Practice (GCP) guidelines, protocols, and regulatory requirements. The Senior CRA will be responsible for monitoring trial progress, data integrity, and patient safety across multiple sites. This is an exceptional opportunity for a motivated professional to contribute to critical research initiatives within the pharmaceutical and biotechnology sectors, based in the scenic Queenstown area. The position demands a meticulous approach, strong organizational skills, and excellent interpersonal abilities to foster effective relationships with investigators, site staff, and internal teams. You will play a crucial part in bringing life-changing therapies to patients by ensuring the quality and reliability of clinical trial data and operations. The role offers significant autonomy and responsibility, making it ideal for a seasoned professional looking to advance their career in clinical research.

Key Responsibilities

• Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites.
• Ensure adherence to study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical trial data through source document verification.
• Manage site-level trial activities, including patient recruitment, informed consent process, and adverse event reporting.
• Build and maintain strong working relationships with investigators, site staff, and study sponsors.
• Identify and resolve site-specific issues and deviations promptly.
• Prepare and submit accurate monitoring visit reports in a timely manner.
• Oversee the training of site personnel on study protocols and procedures.
• Ensure the proper management and accountability of investigational products and study supplies.
• Contribute to the development of study plans and site selection criteria.

Requirements

• Bachelor's degree in a life science, nursing, pharmacy, or a related scientific discipline.
• A minimum of 5 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial management role.
• Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in site monitoring, data verification, and regulatory compliance.
• Excellent organizational, time management, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to communicate effectively with diverse stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel as required to assigned clinical trial sites.
• Detail-oriented with a high degree of accuracy.
• Proactive and able to work independently with minimal supervision.

Benefits

• Competitive salary package with performance-based bonuses.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan with company contributions.
• Allowance for travel expenses and mileage reimbursement.
• Opportunities for professional development and advanced training in clinical research.
• A supportive and collaborative team environment.
• Chance to work on impactful clinical trials that improve patient health.
• Flexible working arrangements with hybrid options.