Syneos Health
Life sciences
CRAII
“CRA II at Syneos Health. Skills: Clinical research monitoring, GCP guidelines, Regulatory requirements. Conduct on-site and remote monitoring of clinical research studies. Ensure compliance with clinical practices”
What You'll Achieve.
accelerate customer success; navigate complexity; anticipate change; accelerate progress; help our customers achieve their goals; show up each day and shape solutions that have the ability to dramatically impact someone’s life; driving impact for customers; defining the pace of patient progress
Industry & Context.
Problem-solving abilities; critical thinking; analytical skills
What They're Looking For.
Must Have
Bachelor's degree in a related field or equivalent experience, Minimum of 2-4 years of experience in clinical research monitoring, 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, Attention to detail and analytical skills, Problem-solving abilities and critical thinking, Ability to work effectively in a team environment, organizational and time management skills, Proficiency in Microsoft Office Suite
Nice to Have
Certified Clinical Research Associate (CCRA) or equivalent certification
What You'll Do.
Conduct on-site and remote monitoring of clinical research studies
Ensure compliance with clinical practices
Review study protocols
Review informed consent forms
Review case report forms
and processes for quality monitoring
Create monitoring plans
and delivery of processes
Participate in development of standard operating procedures
Participate in development of training materials
Manage defined components of projects
Manage defined components of processes
Coordinate site visits
Ensure accurate documentation of monitoring activities
Ensure timely documentation of monitoring findings
Write monitoring reports
Write follow-up letters
How You'll Work.
Team & Collaboration
Collaborate with cross-functional teams to support clinical trial operations; Work with investigators; Work with site staff; Work with other stakeholders to ensure smooth study conduct; Collaborate with passionate problem solvers; Innovating as a team
Communication Scope
Excellent communication and interpersonal skills
Process & Methodology
Manage defined components of projects
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