Clinical Research Associate

Our client, an emerging biotech scaling its clinical operations function, is seeking a Clinical Research Associate/Coordinator to support the execution of ongoing clinical trials. This is a great opportunity for someone who wants hands-on exposure to a growing pipeline and the chance to help shape processes as the company scales. Key ResponsibilitiesConduct site selection, initiation, monitoring, and close-out visits in accordance with the approved scope of work and Good Clinical Practice (GCP)Perform on-site and remote monitoring of investigational sites, including source document verification and case report form reviewTrack site performance, enrollment metrics, and protocol deviations; escalate issues as neededMaintain and reconcile the Trial Master File (TMF) to ensure inspection readinessCoordinate with investigators, site coordinators, and internal study teams to keep trial timelines on trackSupport regulatory document collection and IRB/EC submissions as neededAssist with vendor coordination (labs, IRT, imaging, etc.) as applicable to study needsQualificationsBachelor's degree in life sciences, nursing, public health, or a related field (or equivalent relevant experience)2+ years of CRA or clinical research coordination experience in a pharma, biotech, or CRO settingWorking knowledge of ICH-GCP and FDA regulatory requirementsExperience with EDC systems, CTMS, and eTMF platformsStrong organizational skills and comfort managing multiple priorities in a fast-moving environmentWillingness to travel to site visits as required Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.