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About the Role

Syneos Health is a life sciences services organization that partners with innovators to accelerate drug development and commercialization. Our Clinical Solutions team members apply their expertise to understand customer needs and shape solutions. You will collaborate with passionate problem solvers to help customers achieve their goals.

Responsibilities

• Perform site qualification, initiation, interim monitoring, management, and close-out visits, ensuring compliance with regulatory standards and protocols.
• Evaluate site and staff performance, providing recommendations and escalating serious issues with action plans.
• Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs.
• Verify the process of obtaining informed consent and protect subject confidentiality.
• Assess factors affecting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
• Assess site processes and conduct Source Document Review.
• Verify the accuracy and completeness of clinical data in case report forms.
• Apply query resolution techniques and guide site staff to closure within timelines.
• Utilize hardware and software for effective clinical study data review and capture.
• Verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation, and review storage and security.
• Verify IP dispensing and administration according to the protocol.
• Verify issues or risks associated with blinded or randomized IP information.
• Ensure IP is appropriately (re)labelled, imported, and released/returned.
• Review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Reconcile ISF contents with the Trial Master File (TMF).
• Ensure the investigator site is aware of archiving requirements for essential documents.
• Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
• Support subject recruitment, retention, and awareness strategies.
• Enter data into tracking systems for observations, status, and action items.
• Manage site-level activities and communication to meet project objectives, deliverables, and timelines.
• Adapt to changing priorities to achieve goals and targets.
• Act as a liaison with study site personnel or collaborate with Central Monitoring Associates.
• Ensure trained and compliant site and project-specific team members.
• Prepare for and attend Investigator Meetings and sponsor meetings.
• Participate in global clinical monitoring/project staff meetings and training sessions.
• Provide guidance on audit readiness standards and support audit preparation and follow-up.
• Complete assigned training as required.
• For Real World Late Phase, perform site support throughout the study lifecycle.
• Demonstrate knowledge of local requirements for real-world late-phase study designs.
• Conduct chart abstraction activities and data collection.
• Collaborate with Sponsor affiliates, medical science liaisons, and local country staff.
• Train junior staff as requested.
• Identify and communicate out-of-scope activities.
• Proactively suggest potential sites based on local knowledge.

Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Demonstrated good computer skills and ability to embrace new technologies.
• Ability to manage required travel of up to 75% on a regular basis.
• Must comply with site requests for medical and other personal information for facility access.
• Failure to provide requested information may result in a Site barring entry, putting ongoing employment at risk.

Skills

• Communication skills
• Presentation skills
• Interpersonal skills
• Computer skills
• Embrace new technologies

Location

• US ONLY

Work Type

• Full-time
• Onsite
• Remote
• Hybrid

Experience Level

• CRA 2
• Site Management Associate II

Education Level

• Bachelor's degree
• RN

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 agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
• We are continuously building the company we all want to work for and our customers want to work with.
• We 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.
• We solve some of the toughest challenges facing the most prestigious healthcare companies today.
• The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities.
• We are 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 partner with the most diverse team of experts in the industry.
• We assemble clinical teams where everyone is skilled in the same therapeutic area or customer teams.
• We are partners with purpose, integrating seamlessly with our customers and doing 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.
• 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.