CRA II/ SCRA I

CRA II/ SCRA I (Melbourne/ Sydney) – Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, and we collaborate with passionate problem solvers to help our customers achieve their goals.

Discover what our 29,000 employees, across 110 countries already know: work here matters everywhere.

Why Syneos Health

• We are committed to developing our people through career development, training, and rewards; supportive line management and a culture that values Total Self.
• We value diversity of thought, backgrounds, cultures, and perspectives to create a sense of belonging.

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with Good Clinical Practice and regulatory requirements, including reviewing study protocols, informed consent forms, and case report forms.
• Develop and implement tools, procedures, and processes to ensure quality monitoring (e.g., monitoring plans, checklists, templates).
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including developing standard operating procedures (SOPs) and training materials.
• Manage defined components of projects or processes within the area of responsibility (e.g., coordinating site visits, tracking study progress, resolving issues).
• Ensure accurate and timely documentation of monitoring activities and findings (e.g., monitoring reports, follow-up letters, action plans).
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct.

• Bachelor's degree in a related field or equivalent experience.
• Minimum of 2–4 years of experience in clinical research monitoring.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Excellent communication and interpersonal skills; ability to work independently and manage multiple priorities.
• Proficiency in using clinical trial management systems and other relevant software.

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred.

• Attention to detail, strong analytical and problem-solving skills.
• Ability to work effectively in a team environment; strong organizational and time management skills.
• Proficiency in Microsoft Office Suite.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and 200+ studies across 73,000 sites and 675,000+ trial patients. We value initiative and the ability to challenge the status quo in a competitive and changing environment.

The duties listed are not exhaustive. The Company may assign additional tasks as needed. Equivalent experience, skills, and education will be considered. The Company may determine what constitutes equivalent qualifications. The information herein is not intended to create a contract. The Company complies with applicable laws, including the EU Equality Directive and the Americans with Disabilities Act, including reasonable accommodations where appropriate.

Summary

Roles within the Clinical Monitoring/CRA family at the P21 level are responsible for conducting on-site and remote monitoring, developing monitoring tools and processes, and contributing to the design and delivery of programs and policies. This is an individual contributor role with potential to manage two or fewer employees and a focus on applying professional knowledge to ensure integrity and quality of clinical trials.

Adelaide, South Australia, Australia – for reference in the original footer content.