CRA I, no monitoring experience required

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

📋 Description

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

• Assess site and site personnel performance while providing recommendations and action plans.

• Stay updated on ICH/GCP guidelines, relevant regulations, and company SOPs/processes.

• Confirm informed consent, confidentiality, subject safety, clinical data integrity, and adherence to protocols.

• Evaluate site processes and perform source document reviews on site documentation and medical records.

• Ensure the accuracy and completeness of clinical data entered in case report forms.

• Employ query resolution techniques and drive query resolutions to completion within established timelines.

• Utilize hardware and software for clinical project data review and collection.

• Verify compliance with electronic data capture standards.

• Conduct inventory, reconciliation, storage, dispensing, administration, labeling, import, and return reviews of investigational products as necessary.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Archive essential documents in accordance with local guidelines and regulatory requirements.

• Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other necessary project documents.

• Assist with strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, ongoing statuses, and action items using tracking systems.

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

• Serve as a liaison with project site personnel, either independently or alongside another CRA or Central Monitoring Associate.

• Ensure training and compliance of assigned sites and project-specific site team members.

• Prepare for and participate in Investigator Meetings, sponsor meetings, global monitoring meetings, and clinical training sessions.

• Facilitate audit readiness, preparation, and follow-up actions.

• For Real World Late Phase studies, support the study lifecycle from site identification to close-out, including chart abstraction, data collection, and collaboration with sponsor affiliates, medical science liaisons, and local country staff.

⛳️ Requirements

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

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

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

• Exceptional communication, presentation, and interpersonal skills.

• Capability to manage up to 75% travel regularly.

• For Real World Late Phase: understanding of local requirements for real world late phase study designs.

• For Real World Late Phase: ability in chart abstraction and data collection.

• Flexibility to adapt to changing priorities under the supervision of the Lead CRA.

• Capacity to ensure that assigned sites and project-specific site team members receive necessary training and comply with applicable requirements.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Emphasis on a Total Self culture.

• Initiatives promoting diversity, inclusion, and a sense of belonging.

• Access to comprehensive resources including emerging technologies, data, science, and knowledge sharing.

• Provision of reasonable accommodations, where appropriate.