CRA I, Sydney or Melbourne (no monitoring experience required)

Syneos Health, Inc.

Job Overview

Location

AUS-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Performs site qualification, site initiation, interim monitoring, and close-out visits (on-site or remotely) 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 patient information throughout the study lifecycle.
• Conducts source document reviews and verifies accuracy and completeness of clinical data entered into case report forms (CRFs), applying query resolution techniques both remotely and on-site.
• Monitors investigator site compliance with electronic data capture requirements and supports data review and capture using available hardware and software systems.
• Manages investigational product (IP) inventory, reconciliation, storage, and security; confirms IP is dispensed and administered per protocol and ensures proper relabeling, import, and return procedures are followed.
• Reviews and reconciles the Investigator Site File (ISF) for accuracy, timeliness, and completeness, ensuring alignment with the Trial Master File (TMF) and adherence to local archiving regulations.
• Documents all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with company SOPs and the Clinical Monitoring Plan/Site Management Plan.
• Supports subject recruitment and retention strategies and enters observations, status updates, and action items into tracking systems to ensure timely resolution.
• Acts as primary liaison with site personnel or collaborates with other CRAs and Central Monitoring Associates to ensure site training and compliance with regulatory and protocol requirements.
• Prepares for and participates in Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings as required by the project.
• Provides guidance to sites to achieve audit readiness and supports preparation for and follow-up of regulatory audits.
• For Real World Late Phase studies, performs chart abstraction and data collection, supports site identification through close-out, and collaborates with Sponsor affiliates, medical science liaisons, and local country staff.
• Manages site-level activities within project scope, budgets, and timelines, adapting quickly to changing priorities under the oversight of the Lead CRA.
• Maintains current knowledge of ICH/GCP guidelines, applicable regulations, and company standard operating procedures (SOPs).
• Demonstrates strong computer skills and proficiency in adopting new technologies to support clinical trial operations.
• Travels up to 75% of the time to investigator sites as required for on-site monitoring activities.

🎯 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 other applicable regulatory requirements
• Ability to manage required travel of up to 75% on a regular basis
• Excellent communication, presentation, and interpersonal skills
• Demonstrated 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 focused on authenticity and purpose-driven work
• Opportunity to contribute to drug development impacting patient outcomes

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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