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About the Role

Syneos Health's Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. Join a team of passionate problem solvers innovating to help customers achieve their goals in an agile and driven environment.

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 informed consent processes and protect subject/patient confidentiality.
• Assess factors affecting subject/patient 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 in CRFs and drive query resolution.
• 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 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/physician sites are aware of essential document archiving requirements.
• Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
• Support subject/patient recruitment, retention, and awareness strategies.
• Enter data into tracking systems to monitor observations, status, and action items.
• Understand project scope, budgets, and timelines for assigned activities.
• Manage site-level activities and communication to meet project objectives and timelines.
• Adapt to changing priorities to achieve goals and targets.
• Act as a primary liaison with study site personnel or collaborate with Central Monitoring Associate.
• Ensure trained and compliant site and project-specific site 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.
• For Real World Late Phase, use the title Site Management Associate II.
• Provide site support throughout the study lifecycle.
• Demonstrate knowledge of local requirements for real-world late-phase study designs.
• Perform chart abstraction 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.
• Must demonstrate good 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.

Skills

• Drug development
• Clinical monitoring
• Site management
• Regulatory compliance
• ICH-GCP
• Good Pharmacoepidemiology Practice (GPP)
• Protocol compliance
• Problem-solving
• Communication
• Presentation
• Interpersonal skills
• Computer skills
• Technology adoption
• Data management
• Investigational product handling
• Audit readiness

Location

• Remote
• On-site

Work Type

• Full-time

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

About the Company

• Syneos Health is a leading fully-integrated life sciences services organization accelerating customer success.
• We partner with innovators across the drug development and commercialization continuum.
• 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.

Equal Opportunity

• We are committed to building an inclusive culture – where you can authentically be yourself.
• 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.