Clinical Research Associate Service

Clinical Research Associate – Full-Service

Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes.

• Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Use judgment and experience to evaluate the overall performance of a site and site staff, provide recommendations regarding site‑specific actions, and immediately communicate/escalate serious issues to the project team while developing action plans.
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required, protecting confidentiality and assessing factors that might affect subject safety and data integrity.
• Assess site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP) and conduct source document review to verify required clinical data entered in the case report form (CRF) is accurate and complete.
• Apply query resolution techniques remotely and on‑site, guide site staff as necessary, and drive query resolution to closure within agreed timelines.
• Utilize hardware and software to support effective conduct of clinical study data review and capture, and verify site compliance with electronic data capture requirements.
• Perform investigational product (IP) inventory, reconciliation, storage and security reviews, verify dispensing and administration of IP to subjects/patients, and manage IP labeling, import, release and return as required.
• Review the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconcile it with the Trial Master File (TMF), and ensure sites are aware of archiving requirements.
• Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and the Clinical Monitoring Plan/Site Management Plan.
• Support subject recruitment, retention and awareness strategies, and enter data into tracking systems to monitor observations, status and assigned action items.
• Understand project scope, budgets and timelines; manage site‑level activities and communication to ensure project objectives, deliverables and timelines are met, adapting to changing priorities.
• Serve as the primary liaison with study site personnel or in collaboration with Central Monitoring Associates, ensuring training and compliance with requirements.
• Prepare for and attend investigator meetings, sponsor face‑to‑face meetings, global clinical monitoring/project staff meetings and clinical training sessions as required.
• Provide guidance at the site and project level toward audit readiness standards and support preparation for audit and follow‑up actions.
• For Real World Late Phase, act as Site Management Associate II and support site activities throughout the study lifecycle, including chart abstraction and data collection.
• Collaborate with Sponsor affiliates, medical science liaisons and local country staff, and train junior staff when requested.
• Identify and communicate out‑of‑scope activities to Lead CRA/Project Manager, and proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and healthcare provider associations.

• 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 proficiency with computer technologies and willingness to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% of the time.
• U.S. only: deployment may require providing medical and personal information for site access; compliance with all site requests is mandatory.

The benefits for this position may include a company…