Clinical Research Associate - Full-Service

Clinical Research Associate – Full-Service Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success and improving patient outcomes. Job Responsibilities 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. Qualifications 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. Benefits The benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time (subject to state and municipal regulations). Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies and proficiency for the role. Additional Information Tasks, duties and responsibilities listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign additional tasks, duties and responsibilities. Equivalent experience, skills and/or education will also be considered to meet qualifications. The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations when appropriate. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC