[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. NAMSA is a pioneering organization in the medical device materials industry, focused on safety and regulatory compliance. The Senior Clinical Research Associate will ensure adherence to Good Clinical Practice and manage clinical site monitoring responsibilities, while serving as the primary contact for study-related inquiries and supporting various study activities.ResponsibilitiesWorks on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followedCoordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelinesMay conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visitsServe as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as neededCommunicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concernsSupports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etcPerforms study-related trainingManages the development and maintenance of study documents, processes and systems as assignedEnsures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewalsTracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenanceAttends internal and external meetings as requiredProvides all job-related progress reports and visit documentation as requiredMay support safety activities such as narrative writing, managing the CEC/DSMB, etcOUS: Prepares and coordinates submissions to regulatory authoritiesMay perform other activities as assignedAssess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection processAssists with the coordination of the site budget and contract negotiations as directed by the project lead(s)Assists in preparing sites for audits and in resolving audit action itemsSupports sites during audits remotely and/or onsite as neededParticipates in meetings with prospective clientsSupports training and mentoring of CRAs during remote and onsite visitsManages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documentsAssists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations developmentSupports Core Laboratory management and may serve as the primary contactSupports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasksPerforms and summarizes literature searchesRegisters trials on Clinicaltrials.govSkillsFluency in English and local language, if different, requiredCompany OverviewNAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine. It was founded in 1967, and is headquartered in Northwood, Ohio, USA, with a workforce of 1001-5000 employees. Its website is http://www.namsa.com/.Company H1B SponsorshipNAMSA has a track record of offering H1B sponsorships, with 1 in 2025. Please note that this does not guarantee sponsorship for this specific role.