Experienced Clinical Research Associate - Sponsor Dedicated

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 overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and develop 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/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient. Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): assess site processes; conduct Source Document Review of appropriate site source documents and medical records; verify required clinical data entered in the case report form (CRF) is accurate and complete; apply query resolution techniques remotely and on site, provide guidance to site staff as necessary, drive query resolution to closure within agreed timelines. Utilize available hardware and software to support the effective conduct of the clinical study data review and capture; verify site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation, reviews storage and security; verify the IP has been dispensed and administered to subjects/patients according to the protocol; verify issues or risks associated with blinded or randomized information related to IP; apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile contents of the ISF with the Trial Master File (TMF); ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understand project scope, budgets, and timelines; manage site‑level activities/communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals/targets; may act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensure all assigned sites and project‑specific site team members are trained and compliant with applicable requirements. Prepare for and attend Investigator Meetings and/or sponsor face‑to‑face meetings; participate in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements. Provide guidance at the site and project level towards audit‑readiness standards and support preparation for audit and required follow‑up actions. Maintain working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required. For Real World Late Phase, the CRAII will use the business card title of Site Management AssociateII; additional responsibilities include site support throughout the study lifecycle from site identification through close‑out, knowledge of local requirements for real‑world late‑phase study designs, chart abstraction activities and data collection, collaboration with Sponsor affiliates, medical science liaisons and local country staff, training junior staff, identifying and communicating out‑of‑scope activities to Lead CRA/Project Manager, and proactively suggesting potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (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 applicable regulatory requirements. Must demonstrate good computer skills and be able 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: As part of your employment with Syneos Health, you may be deployed to sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits Company car or car allowance. Health benefits to include medical, dental and vision. Company match 401(k). Eligibility to participate in Employee Stock Purchase Plan. Eligibility to earn commissions/bonus based on company and individual performance. Flexible paid time off (PTO) and sick time (eligible per state/local requirements). Equal Opportunity Employment & Legal Compliance 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 to perform the essential functions of the job. The Company will determine what constitutes as equivalent to the qualifications described above and may assign other tasks, duties, and responsibilities as listed in this job description. All applicants will be treated fairly and without discrimination. #J-18808-Ljbffr