Sr. Clinical Research Associate (US)

Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv ’s and sponsor’s standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/ Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required. Site Monitoring activities (55-60%) Independently conduct and document onsite and remote activities, including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance. Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements. Monitor, resolve and/or facilitate resolution of data queries and escalate issues as appropriate. Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents. Ensures site staff is trained in all aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP. Participate in routine study progress meetings, teleconferences, and Investigator’s meetings. Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) Act as a primary contact for any questions or issues that arise from investigational sites. Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members. Facilitate and support site staff with access to study systems and