FSP- Sr CRA II (Melbourne/ Sydney) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug developm…
Skills: Clinical research monitoring, Protocol compliance, Regulatory documentation, Monitoring plans, Standard operating procedures
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FSP Senior CRA I/ II (Melbourne/ Sydney home based)
Australia · Remote OK
Senior$525M raised
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Mid level$525M raised
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Entry level$525M raised
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Central Risk Manager (RBQM & Central Monitoring) - Remote: United States or Canada
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Mid level$525M raised
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Sr/II Site Contracts Specialist - DACH contract negotiations experience
Greece · Remote Solely
Senior$525M raised
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Full-time
bachelor degree
Career development, Technical and therapeutic area training, Peer recognition, Total rewards program
Posted 8h ago
~40 hrs/week
Remote in Melbourne, Victoria, Australia, Sydney, New South Wales, Australia
Responsibilities
The Senior CRA II conducts on-site and remote monitoring of clinical research studies to ensure compliance with protocols and regulatory standards. They also provide mentorship to junior staff, develop monitoring tools, and collaborate with cross-functional teams to ensure successful trial execution.
Requirements
Candidates must hold a bachelor's degree and have a minimum of 5 years of experience in clinical research monitoring. Proficiency in clinical trial management systems and a strong understanding of GCP guidelines and regulatory requirements are essential.
Full job description
FSP- Sr CRA II (Melbourne/ Sydney)
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documents
Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures
Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages
Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities
Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise
Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders
Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases
Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
Collaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialists
Qualifications:
Bachelor's degree in a related field
Minimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA I
In-depth knowledge of clinical trial processes and regulations
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Certifications:
Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Necessary Skills:
Proficiency in clinical trial management systems and software
Ability to manage multiple projects and priorities
Strong attention to detail and organizational skills
Ability to travel as required for on-site monitoring
Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
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.
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, commercial and real world insights into outcomes to address modern market realities.
We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together we share diverse insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
Syneos Health is powered by an authentic, inclusive and high-performance culture that cares for colleagues, customers, patients, communities and the environment.
Offices: 1030 Sync Street, Morrisville, NC 27560, US
Clinical Trials and Biopharmaceutical Product Lifecycle ManagementHealth CareBiotechnologyPharmaceuticalTherapeutics
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, commercial and real world insights into outcomes to address modern market realities.
We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together we share diverse insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
Syneos Health is powered by an authentic, inclusive and high-performance culture that cares for colleagues, customers, patients, communities and the environment.
Offices: 1030 Sync Street, Morrisville, NC 27560, US
Clinical Trials and Biopharmaceutical Product Lifecycle ManagementHealth CareBiotechnologyPharmaceuticalTherapeutics