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About the Role

Syneos Health is a life sciences services organization that partners with innovators across the drug development and commercialization continuum. Our Clinical Solutions team members act with a drug development mindset, applying their expertise to understand and shape solutions that meet customer needs. We are agile and driven to deliver for our customers and those in need.

Responsibilities

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
• Assist Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies.
• Communicate with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
• Create and maintain project files and handle project correspondence.
• Participate in file audits.
• Prepare and maintain site manuals, reference tools and other documents.
• Maintain, update, and input clinical tracking information into databases.
• Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manage shared mailbox, process site requests and route correspondence appropriately.
• Coordinate the ordering, packaging, shipping and tracking of site supplies and materials.
• Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items.
• Routinely anticipate, identify and resolve potential issues and implement corrective actions, seeking guidance as needed.
• Maintain overall awareness in the field of clinical research and assigned areas by completing all necessary training.
• May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

Requirements

• Associates degree preferred or equivalent experience in clinical research/pharma/biotech or related field.
• Good knowledge of medical terminology, clinical data, and ICH/GCP preferred.
• Ability to successfully prioritize and work on multiple tasks.
• Strong attention to detail, accuracy and organizational skills.
• Excellent communication, presentation, and interpersonal skills.
• Ability to embrace new technologies.

Work Type

• Minimal travel up to 10% may be required

Experience Level

• Senior

Education Level

• Associates degree preferred or equivalent experience

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Comprehensive resources including emerging technologies, data, science and knowledge sharing

About the Company

• 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.
• We are passionate about developing our people.
• We are committed to building an inclusive culture.
• We are continuously building the company we all want to work for and our customers want to work with.
• 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.
• 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.
• We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans.
• The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities.
• We’re a growing, global company dedicated to advancing our talent past their initial role.
• A career with Syneos Health means your everyday work improves patients’ lives around the world.
• We work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams.
• We are partners with purpose.
• We integrate seamlessly with our customers and do what’s best for their success.
• Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Equal Opportunity

• 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.