CRA I, Australia (no monitoring experience required)

Syneos Health, Inc.

Job Overview

Location

AUS-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Performs site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and protocol requirements.
• Verifies that informed consent processes are properly documented for each subject/patient and ensures confidentiality of subject/patient information.
• Conducts source document reviews and verifies accuracy and completeness of clinical data entered into case report forms (CRFs).
• Applies remote and on-site query resolution techniques, guiding site staff to resolve data discrepancies within agreed timelines.
• Monitors and verifies compliance with electronic data capture requirements at investigator sites.
• Manages investigational product (IP) inventory, reconciliation, storage, and security; confirms IP is dispensed and administered per protocol and correctly relabeled, imported, or returned.
• Reviews and maintains the Investigator Site File (ISF) for accuracy, timeliness, and completeness; reconciles ISF contents with the Trial Master File (TMF).
• Documents all monitoring activities using confirmation letters, trip reports, follow-up letters, and communication logs in accordance with SOPs and Clinical Monitoring/Site Management Plans.
• Supports subject recruitment and retention strategies and enters tracking data into required systems to monitor site status and action items to resolution.
• Manages site-level activities, communication, and timelines in alignment with project scope, budgets, and deliverables, adapting to changing priorities under the guidance of a Lead CRA.
• Acts as primary liaison between Syneos Health and site personnel or in collaboration with other CRAs or Central Monitoring Associates (CMAs).
• Trains and ensures compliance of site staff with applicable regulatory and company requirements.
• Prepares for and attends Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings as required.
• Supports audit readiness by ensuring sites meet documentation and compliance standards and assists with follow-up actions post-audit.
• For Real World Late Phase studies, performs chart abstraction and data collection, supports sites throughout the study lifecycle, and collaborates with Sponsor affiliates, medical science liaisons, and local country staff.
• Maintains current knowledge of ICH/GCP guidelines, relevant regulations, and company SOPs/processes.
• Uses computer systems and software tools to support clinical data review, capture, and monitoring activities.
• Must be able to manage up to 75% regular travel to investigator sites across Australia.
• Demonstrates strong judgment and experience in evaluating site performance, identifying risks to data integrity or subject safety, and escalating serious issues to the project team.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements
• Excellent communication, presentation, and interpersonal skills
• Ability to manage up to 75% regular travel
• Strong computer skills and ability to embrace new technologies

🏖️ Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture supporting authentic self-expression
• Purpose-driven work focused on accelerating patient progress

Skills & Technologies

GCP

Design

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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