Job Overview 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 escale 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).
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Contact Details:
3004 Syneos Health UK Limited Recruitment Team
