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About the Role

Syneos Health is a leading 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, collaborating with passionate problem solvers to help customers achieve their goals. We are agile and driven to deliver for our colleagues, customers, and those in need.

Responsibilities

• Perform site qualification, initiation, interim monitoring, management, and close-out visits, ensuring regulatory, ICH-GCP, GPP, and protocol compliance.
• 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 informed consent processes and protect subject confidentiality.
• Assess factors affecting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
• Assess site processes, conduct Source Document Review, and verify data accuracy and completeness.
• Apply query resolution techniques and guide site staff to closure within timelines.
• Utilize hardware and software for effective study data review and capture.
• Verify compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation, and review storage and security.
• Verify IP dispensing and administration according to protocol.
• Address issues or risks associated with blinded or randomized IP information.
• Ensure IP is appropriately (re)labelled, imported, and released/returned.
• Review Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Reconcile ISF contents with the Trial Master File (TMF).
• Ensure investigator sites archive essential documents according to local guidelines.
• 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 scope, budgets, 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 face-to-face meetings.
• Participate in global clinical monitoring/project staff meetings and attend clinical training.
• 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 to Lead CRA/Project Manager.
• 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 computer skills and ability to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• 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 as a condition of employment.
• Failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.

Skills

• Clinical Monitoring
• Site Management
• Regulatory Compliance
• ICH-GCP
• Good Pharmacoepidemiology Practice (GPP)
• Protocol Compliance
• Informed Consent Process
• Subject Confidentiality
• Subject Safety Assessment
• Clinical Data Integrity
• Protocol Deviation Assessment
• Pharmacovigilance
• Source Document Review
• Data Verification
• Query Resolution
• Electronic Data Capture
• Investigational Product (IP) Management
• Investigator Site File (ISF) Management
• Trial Master File (TMF)
• Document Archiving
• Trip Reporting
• Communication Logging
• Subject Recruitment Support
• Subject Retention Support
• Subject Awareness Strategies
• Data Tracking Systems
• Project Scope Management
• Budget Management
• Timeline Management
• Adaptability
• Prioritization
• Liaison Skills
• Team Training
• Audit Readiness
• Real World Late Phase Studies
• Chart Abstraction
• Data Collection
• Collaboration
• Site Identification
• Treatment Pattern Knowledge
• Patient Advocacy Knowledge
• Health Care Provider (HCP) Association Knowledge

Location

• Remote
• On-site

Work Type

• Full-time
• Contract

Experience Level

• CRA II
• 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
• Emerging technologies
• Data, science, and knowledge sharing
• Multiple career paths
• Employment opportunities

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.
• 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.
• 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 work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• 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 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.