Clinical Research Associate - Full-Service

Clinical Research Associate Job Responsibilities Performs 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. Uses judgment to evaluate overall performance of site and staff; recommends site‑specific actions; escalates serious issues; develops action plans. Maintains knowledge of ICH/GCP Guidelines, regulations and company SOPs/processes. Verifies informed consent process is adequately performed and documented for each subject. Protects confidentiality of subjects; assesses safety and data integrity; addresses protocol deviations, violations, pharmacovigilance issues. Assesses site processes per CMP/SMP; conducts source document review; verifies CRF data accuracy and completeness. Applies query resolution techniques remotely and on site; drives closure within agreed timelines; supports hardware/software use for data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product inventory, reconciliation and storage/security review; verifies IP dispensing and administration; checks IP issues related to blinding or randomization; ensures proper (re)labeling, import and release/return. Reviews Investigator Site File for accuracy, timeliness, completeness; reconciles with Trial Master File; ensures archiving of essential documents per guidelines. Documents activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents per SOPs. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems to monitor observations, status and action items. Manages site‑level activities, communication to meet project objectives, deliverables and timelines. Adapt rapidly to changing priorities to meet goals and targets. Acts as primary liaison with study site personnel or collaborates with Central Monitoring Associate. Trains and ensures compliance of assigned sites and project‑specific site team members. Prepares for and attends Investigator Meetings and/or sponsor face‑to‑face meetings; participates in global clinical monitoring/project staff meetings; attends training sessions as required. Guides audit readiness and supports preparation for audit and follow‑up actions. For Real World Late Phase, uses Site Management Associate II title; provides site support throughout study lifecycle, chart abstraction, data collection. Collaborates with Sponsor affiliates, medical science liaisons, local country staff; may train junior staff; identifies and communicates out‑of‑scope activities to Lead CRA/Project Manager. Suggests potential sites based on local knowledge of treatment patterns, patient advocacy and HCP 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 regulatory requirements. 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. US‑only: May be deployed to sites requiring medical and personal information for facility access per Employee Privacy Notice; compliance with site requests is required; failure to provide may result in entry denial and risk to employment. Benefits Company car or car allowance. Health benefits including Medical, Dental and Vision. Company match 401(k). Eligibility to participate in Employee Stock Purchase Plan. Eligibility to earn commissions/bonuses based on company and individual performance. Flexible paid time off (PTO) and sick time (state and municipality specific). Salary Range The base salary range reflects anticipated low and high estimates; actual salary may vary based on qualifications, skills, and proficiency. Equal Opportunity & Accessibility Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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 in performing the essential functions of the job. #J-18808-Ljbffr 1001 Syneos Health, LLC