Remote Clinical Research Associate Job at Parexel Australia
Step into a high-impact Clinical Research Associate Job where science meets global healthcare innovation. This exciting opportunity with Parexel offers flexible Remote Job options and access to top-tier jobs in Australia, allowing you to work on international clinical trials while advancing your career. If you’re searching for a rewarding Clinical Research Job and a strong job opportunity for life science graduates, this role is your gateway to global success.
About Parexel
Parexel Careers is part of a globally leading contract research organization (CRO) that supports the development of innovative therapies worldwide. With a strong presence in jobs in Australia, Parexel is known for delivering high-quality clinical research solutions while fostering career growth. It offers excellent job opportunity for life science graduates and experienced professionals seeking impactful Clinical Research Job roles in a collaborative and flexible environment.
Job Details:
- Job Title: Clinical Research Associate I – II
- Primary Location: North Ryde, Australia
- Additional Locations: Australia (Remote)
- Job ID: R0000038288
- Category: Clinical Trials
Clinical Research Associate Role Summary
The Clinical Research Associate (CRA) serves as an integral contributor to accelerating the delivery of treatments to patients. The role prioritizes patient safety and well-being while performing monitoring duties at investigator sites.
The CRA is expected to demonstrate inquisitiveness, accountability, integrity, and the ability to build strong professional relationships. The individual will work within a diverse and experienced team on global projects spanning multiple therapeutic areas, contributing both personally and professionally while supporting colleagues across functions and geographies.
Role Requirements
- Open to experienced CRAs based in Melbourne or Sydney.
- Requires CRA experience in Australia or New Zealand, including at least 1 year of independent monitoring.
Key Accountabilities
- Site Management (Initiation through Close-out)
- Act as the primary contact with assigned sites, ensuring integrity of study implementation and adherence to study protocols.
- Build and maintain relationships with investigators and site staff.
- Support sites with access to study systems and ensure compliance with training requirements.
- Evaluate site staff assignments and implement corrective actions where necessary.
- Identify, address, and resolve site-related issues, including documentation deficiencies and training needs.
- Follow up on previous visit issues and respond to site queries.
- Identify and evaluate potential data quality and integrity issues and implement follow-up actions.
- Participate in investigator meetings, audits, and regulatory inspections.
- Collect, review, and approve site documentation, including regulatory documents.
- Evaluate and improve site recruitment strategies.
- Conduct on-site visits (qualification, initiation) and remote visits as required.
- Generate visit and contact reports.
- Assess site compliance, performance, and staff capability, providing recommendations.
- Manage study supplies, including accountability and return/destruction processes.
- Monitor site payments, CRF data entry, query resolution, and serious adverse events (SAEs).
- Conduct study-specific training where applicable.
- Perform site facility assessments.
- Identify impacts of non-compliance or delays on study timelines and communicate issues with proposed solutions.
- Overall Responsibilities (Site Identification to Close-out)
- Ensure timely and accurate completion of project goals and updates in trial management systems.
- Collaborate with team members to achieve project objectives and improve planning efficiency.
- Maintain and update Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), IVRS, SIS, and Trial Master File (TMF) documentation.
- Ensure sites are audit- and inspection-ready.
- Maintain compliance with ICH-GCP guidelines and applicable regulations.
- Delegate tasks to Administrative Support Teams where appropriate and provide feedback.
- Deliver consistent, high-quality work and maintain a results-oriented environment.
- Foster collaboration and open communication within teams.
- Maintain knowledge of SOPs, regulations, and study-specific procedures.
- Understand project scope, milestones, and budgets to ensure efficient delivery.
- Provide input for performance development discussions.
- Keep management informed of progress and issues.
- Develop subject matter expertise.
- Work independently with minimal supervision.
- Complete administrative tasks such as timesheets and expense reporting in a timely manner.
Education
- Degree in biological sciences, or other health-related disciplines preferred; or
- Equivalent nursing qualification or relevant equivalent experience.
Knowledge and Experience
- Experience in site management or equivalent clinical research experience.
- Understanding of clinical trial methodologies and terminology
Skills Required for Clinical Research Associate Job
- Strong problem-solving abilities.
- Ability to work independently and take initiative while seeking guidance when needed.
- Advanced presentation skills.
- Client-focused approach.
- Professional interaction within client organizations.
- Flexibility in adapting to assignments and learning opportunities.
- Strong prioritization and analytical skills for managing multiple tasks and timelines.
- Ability to work effectively in a matrix and team-oriented environment.
- Proficiency in CTMS, EDMS, and MS Office tools such as Excel and Word.
- Strong interpersonal, verbal, and written communication skills.
- High sense of urgency and commitment to patient safety.
- Effective time management.
- Ability to work across cultures.
- Capability to work in virtual team environments.
- Consulting skills and attention to detail.
- Willingness to travel extensively as required.
- Valid driver’s license where required.
