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About the Role

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team applies deep expertise to understand customer needs and shape solutions. Team members collaborate in agile, driven environments to achieve customer goals and impact lives.

Responsibilities

• Perform site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulatory standards and protocols.
• Evaluate site and staff performance, escalating serious issues and developing 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 and conduct Source Document Review.
• Verify accuracy and completeness of clinical data against source documents.
• Apply query resolution techniques and guide site staff for timely closure.
• 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/security.
• Verify IP dispensing and administration according to protocol.
• Address issues or risks associated with blinded or randomized IP information.
• Ensure appropriate IP labeling, import, release/return according to GCP/local regulations.
• 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 objectives and timelines.
• Adapt quickly to changing priorities to achieve goals.
• Act as a liaison with project site personnel or collaborate with Central Monitoring Associate.
• Ensure assigned sites and project team members are trained and compliant.
• Prepare for and attend Investigator Meetings and sponsor meetings.
• Participate in and potentially lead global clinical monitoring/project staff meetings.
• Attend clinical training sessions as required.
• Provide guidance on audit readiness standards and support audit preparation and follow-up.
• Provide training or mentorship to junior CRAs.
• Perform training and sign-off visits for junior CRA staff.
• Receive mentorship and perform clinical operations lead tasks under supervision.
• Provide site support throughout the study lifecycle.
• Apply knowledge of local requirements for real-world late phase study designs.
• Conduct chart abstraction and data collection.
• Collaborate with Sponsor, affiliates, medical science liaisons, and local country staff.
• Communicate out-of-scope activities to Lead CRA/Project Manager.
• Proactively suggest potential sites based on local knowledge.
• Identify operational efficiencies and process improvements.
• Develop country-level informed consent forms.
• Collaborate with RWLP Regulatory team for updated regulatory information.
• Participate in bid defense meetings.

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.
• Excellent communication, presentation, and interpersonal skills.
• Basic level of critical thinking skills.
• Ability to manage required travel of up to 75% on a regular basis.

Skills

• Clinical Monitoring
• Site Management
• Regulatory Compliance
• ICH-GCP
• GPP
• Protocol Compliance
• Informed Consent
• Subject Confidentiality
• Pharmacovigilance
• Source Document Review
• Data Verification
• Query Resolution
• Electronic Data Capture
• Investigational Product Management
• Investigator Site File (ISF) Management
• Trial Master File (TMF) Reconciliation
• Document Archiving
• Project Management
• Communication
• Presentation
• Interpersonal Skills
• Critical Thinking
• Travel Management

Location

• Remote
• On-site

Work Type

• Full-time

Experience Level

• Senior

Education Level

• Bachelor's degree
• RN

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.
• 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.
• 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.
• Our purpose – Driven to Deliver – 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.
• 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.
• Learn more about Syneos Health: http://www.syneoshealth.com

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.