CRA II/ SCRA I

2 weeks ago

Adelaide, South Australia Syneos Health Full time
Overview

CRA II/ SCRA I (Melbourne/ Sydney Home based). 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 strive to simplify and streamline our work to be easier to work with for both clients and employees. We are agile and driven to accelerate the delivery of therapies and to change lives.

We hire across a global team of 29,000 employees in 110 countries who are committed to diversity of thought and collaboration. This posting reflects a potential upcoming opportunity; it is not a live role at this time but will be used to evaluate candidates for future openings.

Responsibilities
  • Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
  • Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
  • Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
  • Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
  • Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and 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
Qualifications
  • 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
Certifications
  • Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Necessary Skills
  • Attention to detail and strong analytical skills
  • Problem-solving abilities and critical thinking
  • Ability to work effectively in a team environment
  • Strong organizational and time management skills
  • Proficiency in Microsoft Office Suite
Additional Information

We are excited to connect with great talent. This posting reflects a potential upcoming opportunity rather than a live role. By expressing interest, you'll be added to our talent pipeline and considered should this role become available. The Company reserves the right to assign additional tasks as needed and to determine what constitutes equivalent qualifications. The information provided complies with applicable employment and non-discrimination laws.

Summary

Roles within Clinical Monitoring/CRA job family at the P21 level are responsible for ensuring that clinical research studies are conducted in accordance with clinical practices, including conducting on-site and remote monitoring, developing monitoring tools and procedures, and contributing to process design and delivery. These roles may manage two or fewer employees and focus on making meaningful contributions to the quality and integrity of clinical trials.


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