FSP CRA I

Updated: August 1, 2025
Location: Adelaide, SA, Australia
Job ID:25100302

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

• Conduct comprehensive on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices and study protocols
• Develop and implement tools, procedures, and processes to ensure quality monitoring and adherence to regulatory requirements
• Assist in the design, implementation, and delivery of processes, programs, and policies related to clinical monitoring, ensuring alignment with organizational goals
• Collaborate with study teams to ensure accurate and timely data collection, entry, and reporting, addressing any discrepancies or issues promptly
• Provide guidance and support to lower-level professionals, including training and mentoring, to ensure consistent application of monitoring practices
• Manage processes and programs as needed, ensuring efficient and effective operations within the clinical monitoring function
• Ensure the integrity and quality of clinical data through regular audits, reviews, and verification of source documents and data entries
• Maintain thorough and accurate documentation of monitoring activities, findings, and corrective actions, ensuring compliance with regulatory and organizational standards
• Communicate effectively with study sites, investigators, and other stakeholders to address any issues or concerns related to study conduct and monitoring
• Stay current with industry trends, regulatory changes, and best practices in clinical research and monitoring, incorporating new knowledge into daily practices

Qualifications:

• Bachelor's degree in a relevant field such as life sciences, nursing, or a related discipline
• Previous experience in clinical research or a related field is preferred
• Strong understanding of clinical trial processes and regulations
• Excellent organizational and time management skills
• Ability to work independently and as part of a team

Certifications:

• Certification in clinical research (e.g., CCRP, CCRA) is preferred but not required

Necessary Skills:

• Proficiency in using clinical trial management systems and other relevant software
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Attention to detail and ability to maintain high standards of quality
• Ability to travel as required for on-site monitoring

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Monitoring/CRA at the P20 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes both on-site and remote monitoring, as well as the development of tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributions in a professional or technical discipline, with the possibility of managing two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA at the P20 level play a crucial part in the success of clinical research studies. By ensuring that trials are conducted according to established clinical practices, these roles help maintain the integrity and quality of the research. The development of monitoring tools, procedures, and processes contributes to the overall efficiency and effectiveness of the clinical research program. These roles also support the professional growth of lower-level professionals and the management of processes and programs, thereby contributing to the organization's mission of advancing medical knowledge and improving patient outcomes.Core Focus
• Conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices
• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Supporting the professional growth of lower-level professionals and managing processes and programs
• Ensuring the integrity and quality of clinical research studies through diligent monitoring and adherence to established practices

Description

FSP CRA I (Sydney client based)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

• Conduct comprehensive on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices and study protocols
• Develop and implement tools, procedures, and processes to ensure quality monitoring and adherence to regulatory requirements
• Assist in the design, implementation, and delivery of processes, programs, and policies related to clinical monitoring, ensuring alignment with organizational goals
• Collaborate with study teams to ensure accurate and timely data collection, entry, and reporting, addressing any discrepancies or issues promptly
• Provide guidance and support to lower-level professionals, including training and mentoring, to ensure consistent application of monitoring practices
• Manage processes and programs as needed, ensuring efficient and effective operations within the clinical monitoring function
• Ensure the integrity and quality of clinical data through regular audits, reviews, and verification of source documents and data entries
• Maintain thorough and accurate documentation of monitoring activities, findings, and corrective actions, ensuring compliance with regulatory and organizational standards
• Communicate effectively with study sites, investigators, and other stakeholders to address any issues or concerns related to study conduct and monitoring
• Stay current with industry trends, regulatory changes, and best practices in clinical research and monitoring, incorporating new knowledge into daily practices

Qualifications:

• Bachelor's degree in a relevant field such as life sciences, nursing, or a related discipline
• Previous experience in clinical research or a related field is preferred
• Strong understanding of clinical trial processes and regulations
• Excellent organizational and time management skills
• Ability to work independently and as part of a team

Certifications:

• Certification in clinical research (e.g., CCRP, CCRA) is preferred but not required

Necessary Skills:

• Proficiency in using clinical trial management systems and other relevant software
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Attention to detail and ability to maintain high standards of quality
• Ability to travel as required for on-site monitoring

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Monitoring/CRA at the P20 level are responsible for ensuring that clinical research studies are conducted in accordance with widely accepted clinical practices. This includes both on-site and remote monitoring, as well as the development of tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributions in a professional or technical discipline, with the possibility of managing two or fewer employees. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education.Impact and ContributionRoles within Clinical Monitoring/CRA at the P20 level play a crucial part in the success of clinical research studies. By ensuring that trials are conducted according to established clinical practices, these roles help maintain the integrity and quality of the research. The development of monitoring tools, procedures, and processes contributes to the overall efficiency and effectiveness of the clinical research program. These roles also support the professional growth of lower-level professionals and the management of processes and programs, thereby contributing to the organization's mission of advancing medical knowledge and improving patient outcomes.Core Focus
• Conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices
• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Supporting the professional growth of lower-level professionals and managing processes and programs
• Ensuring the integrity and quality of clinical research studies through diligent monitoring and adherence to established practices

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients' lives around the world. Selecting us as an employer secures a career inwhich you're guaranteed to:

Syneos Health (Nasdaq:SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

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