Senior Clinical Research Associate

Placements24; Queenstown; Hybrid; NZD 120,000 - 166,000; Full time

Benefits offered by this job

Competitive hourly rate/daily rate

Flexible remote working arrangement

Travel expense reimbursement

Professional development resources

Exposure to leading global CRO

Job summary

Placements24 seeks a Senior Clinical Research Associate (CRA) to oversee site conduct for clinical trials in a remote-capable role. You will monitor data quality, ensure regulatory compliance, and liaise between sponsors and investigative sites while traveling to sites as needed.

The ideal candidate has 5+ years as a CRA, strong GCP knowledge, and excellent communication skills. This role offers flexible remote work and the chance to work with a leading global CRO environment.

Qualifications

• 5+ years as a Clinical Research Associate in pharma/biotech/CRO.
• Thorough understanding of ICH GCP guidelines.
• Experience in site monitoring visits.
• Excellent communication and organizational skills.
• Willingness to travel to investigative sites.
• Ability to work remotely.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits for clinical trial sites.
• Ensure the quality and integrity of data collected during clinical trials.
• Verify that participants are adequately informed about study procedures and rights.
• Monitor compliance with study protocol, ICH GCP guidelines, and regulations.
• Manage communication between sponsor, sites, and study-related parties.
• Train site staff on procedures and regulatory requirements.
• Oversee drug accountability at study sites.
• Identify and resolve site-level issues and discrepancies.
• Prepare site monitoring reports and communicate findings to the project team.
• Ensure timely submission of regulatory and ethical documentation.
• Contribute to study plans and essential documents.
• Assist with audits/inspections.

Skills

Site monitoring

GCP knowledge

CTMS

EDC

Communication

Time management

Education

Bachelor's degree in life science

Tools

CTMS

EDC systems

Job description

About the Role

Our client, a leading global Contract Research Organization (CRO) dedicated to advancing life-saving therapies, is seeking an experienced Senior Clinical Research Associate (CRA) to join their dynamic team. This role offers the flexibility of remote work, allowing you to contribute to critical clinical trials from anywhere. You will be responsible for overseeing the conduct of clinical studies at investigative sites, ensuring adherence to protocols, regulations, and Good Clinical Practice (GCP) guidelines. The ideal candidate will possess a strong understanding of clinical trial management, excellent communication skills, and a meticulous attention to detail. This is an excellent opportunity to play a vital role in bringing new medicines to patients while working with a reputable organization known for its commitment to quality and innovation. You will manage multiple sites and foster strong relationships with investigators and site staff, ensuring the smooth and efficient progression of studies. This position is crucial for the successful execution of clinical development programs across diverse therapeutic areas. The role requires a proactive approach to problem-solving and a dedication to ethical research practices.

Key Responsibilities

• Conduct site initiation, monitoring, and close-out visits for clinical trial sites.
• Ensure the quality and integrity of data collected during clinical trials.
• Verify that clinical trial participants are adequately informed about study procedures and their rights as participants.
• Monitor compliance with the study protocol, investigational plan, and all applicable regulations (e.g., GCP, ICH guidelines).
• Manage communication between the sponsor, investigative sites, and other study-related parties.
• Train site staff on study-specific procedures, protocols, and regulatory requirements.
• Oversee drug accountability and investigational product management at study sites.
• Identify, document, and resolve site-level issues and discrepancies in a timely manner.
• Prepare site monitoring reports and communicate findings and recommendations to the project team.
• Ensure timely submission of all required regulatory and ethical documentation.
• Contribute to the development of study plans and essential documents.
• Assist with the preparation for and participation in internal and external audits/inspections.

Requirements

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotech industry, or with a CRO.
• Thorough understanding of ICH GCP guidelines and local regulatory requirements.
• Proven experience in conducting site monitoring visits (initiation, routine, close-out).
• Excellent communication, interpersonal, and organizational skills.
• Strong ability to manage multiple tasks and priorities effectively.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and as part of a remote team.
• Attention to detail and a commitment to data quality and patient safety.
• Willingness to travel to investigative sites as required (frequency may vary).
• A proactive and problem-solving approach to challenges.

Benefits

• Competitive hourly rate or daily rate commensurate with experience.
• Flexible remote working arrangement.
• Opportunity to work on diverse and impactful clinical trials.
• Access to comprehensive training and professional development resources.
• Reimbursement for approved travel expenses.
• Project-based contract with potential for extension.
• Exposure to a leading global CRO environment.
• Work with a dedicated and supportive project team.