CRA II - Multi Sponsor

CRA II – Multi Sponsor at Syneos Health is responsible for ensuring the compliance and quality of clinical trial sites throughout the study lifecycle.

Responsibilities

• Perform site qualification, site initiation, interim monitoring, and site management activities, including close‑out visits performed on‑site or remotely, to ensure regulatory, ICH‑GCP, Good Pharmacoepidemiology Practice (GPP), and protocol compliance.
• Use judgment to evaluate overall site and staff performance, provide recommendations for site‑specific actions, and communicate or escalate serious issues to the project team while developing action plans.
• Maintain a working knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs/processes.
• Verify that informed consent has been obtained and documented appropriately for each subject/patient, protecting confidentiality and assessing factors that may affect safety and data integrity.
• Assess site processes; conduct source document review; verify that required clinical data entered in the case report form (CRF) is accurate and complete.
• Apply query resolution techniques on‑site or remotely, guiding site staff to closure within agreed timelines.
• Utilize hardware and software to support effective conduct of data review and capture, and verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory reconciliation, storage review, and security checks; verify IP dispensing and administration according to protocol.
• Reconcile the Investigator Site File (ISF) with the Trial Master File (TMF) and ensure archiving of essential documents per local guidelines.
• Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents per SOPs and Site Management Plan.
• Support subject recruitment, retention, and awareness strategies; enter data into tracking systems to monitor observations, status, and action items.
• Understand project scope, budgets, and timelines; manage site‑level activities and communications to meet project objectives and deliverables.
• Act as primary liaison with study site personnel, collaborating with Central Monitoring Associates when needed.
• Ensure all assigned sites and team members are trained and compliant with applicable requirements; prepare for Investigator and sponsor face‑to‑face meetings.
• Participate in global clinical monitoring/project staff meetings and attend clinical training sessions per project requirements.
• Provide guidance toward audit readiness and support audit preparation and required follow‑up actions.
• Maintain knowledge of ICH/GCP guidelines and complete assigned training as required.

Additional Responsibilities

• Support sites throughout the study lifecycle from site identification to close‑out.
• Apply 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 when requested.
• Identify and communicate out‑of‑scope activities to Lead CRA or Project Manager.
• Proactively recommend potential sites based on local treatment patterns, patient advocacy, and health‑care provider associations.

Qualifications

• Bachelor’s degree or RN in a related field or an equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Strong computer skills and openness to adopting new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage a travel requirement of up to 75% on a regular basis (US ONLY).