CRA II – SCRA I

This is a fully remote position, open to applicants in Australia.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits both on-site and remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and site staff, providing recommendations or escalating significant issues as necessary.

• Verify informed consent processes, maintain subject/patient confidentiality, and ensure safety and integrity of clinical data.

• Evaluate site processes and perform reviews of source documents.

• Validate clinical data recorded in case report forms against source documents and medical records.

• Address queries remotely and on-site within established timelines.

• Utilize hardware and software for the review and capture of clinical study data.

• Ensure compliance with electronic data capture standards.

• Conduct reviews of investigational product inventory, reconciliation, storage, security, and dispensing as necessary.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Document monitoring activities and maintain comprehensive tracking systems.

• Assist in subject/patient recruitment, retention, and awareness initiatives.

• Oversee site-level activities and communications to achieve project goals, deliverables, and timelines.

• Collaborate with project site personnel to ensure site team training and compliance.

• Prepare for and participate in Investigator and sponsor meetings.

• Take part in or lead clinical monitoring/project staff meetings and attend clinical training sessions.

• Facilitate audit readiness and follow-up actions post-audit.

• Provide training or mentorship to junior Clinical Research Associates (CRAs) and conduct training/sign-off visits as assigned.

• For RWLP: support sites throughout the study lifecycle, conduct chart abstraction and data collection, develop informed consent forms at the country level, collaborate with regulatory teams, identify operational efficiencies, participate in bid defense meetings, and suggest potential sites.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or a combination of education, training, and experience that is equivalent.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal skills.

• Basic critical thinking abilities.

• Capacity to manage regular travel requirements of up to 75%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations for employees or applicants with disabilities when appropriate.