CRA II- Shanghai

CRA II- Shanghai

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 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.