Clinical Research Associate I - II

Role Overview and Responsibilities

This position is open to experienced Clinical Research Associates (CRAs) based in Melbourne or Sydney. Candidates should have at least one year of independent monitoring experience within Australia or New Zealand. As a CRA at Parexel, you will serve as the primary liaison with assigned clinical sites, ensuring adherence to study protocols and maintaining the quality and integrity of study implementation throughout all phases from initiation to closeout.

• Establish and nurture ongoing relationships with investigators and site personnel.
• Support sites with access to study systems and ensure compliance with project-specific training.
• Regularly verify appropriate on-site staff assignments and implement corrective actions when necessary.
• Identify and resolve documentation and protocol compliance issues, including follow-ups from previous visits.
• Respond promptly to site queries and concerns.
• Apply professional judgment to monitor potential data quality and integrity issues, initiating appropriate follow-up actions.
• Participate actively in investigator meetings, audits, and regulatory inspections.
• Review and approve site documentation, including regulatory files.
• Collaborate with site staff to evaluate recruitment strategies and recommend improvements.
• Conduct on-site Qualification and Initiation visits and remote contacts as needed.
• Prepare detailed visit reports.
• Assess site compliance and staff performance, recommending actions as necessary.
• Manage investigational product accountability including supply, destruction, and return.
• Monitor site payment statuses and follow-up on case report form data, queries, and serious adverse events.
• Deliver study-specific training on-site when applicable.
• Conduct facility assessments at clinical sites.
• Communicate the impact of study non-compliance or delays and propose resolutions promptly.

Project and Team Management

• Ensure timely achievement of project goals and maintain updates to trial management systems.
• Collaborate with team members for efficient project planning and execution.
• Maintain accuracy and quality in clinical trial systems, submitting documents to the Trial Master File with high standards.
• Prepare sites for audits and inspections, ensuring compliance with ICH-GCP, local and international regulations.
• Delegate tasks to administrative support and provide guidance and feedback.
• Foster a positive, results-focused work environment promoting high performance culture values.
• Stay updated with company SOPs, sponsor requirements, and study procedures.
• Understand project scopes, milestones, and budgets, striving for prompt and efficient delivery.
• Provide performance feedback and proactively communicate work progress and challenges with management.
• Develop subject matter expertise and work independently with minimal supervision.
• Complete administrative tasks like timesheets, expenses, and metrics timely.

Skills and Competencies

• Strong analytical and problem-solving capabilities.
• Self-motivated with the ability to work autonomously while seeking guidance as needed.
• Excellent presentation and client-facing skills.
• Professional communication within client organizations.
• Adaptability to diverse tasks and eagerness to learn new skills.
• Effective prioritization to meet multiple project timelines.
• Teamwork orientation in matrixed environments.
• Proficiency with clinical trial systems such as CTMS, EDMS, and Microsoft Office (Excel, Word).
• Strong interpersonal, verbal, and written communication skills.
• High attention to detail and sense of urgency to meet deliverables safely.
• Capability to work effectively across cultures and in virtual team settings.
• Consulting skills and willingness to accommodate extensive travel requirements.
• Driver’s license possession where applicable.

Required Knowledge, Experience, and Education

• Experience in site management or comparable clinical research roles with a sound understanding of clinical trial methodology and terminology.
• Degree-level education preferably in biological sciences, pharmacy, nursing, or related health disciplines, or equivalent professional experience.