{"id":16062,"date":"2026-02-27T11:54:45","date_gmt":"2026-02-27T19:54:45","guid":{"rendered":"https:\/\/elixirmedical.com\/?p=16062"},"modified":"2026-02-27T11:55:47","modified_gmt":"2026-02-27T19:55:47","slug":"principal-clinical-research-associate-in-house-principal-cra","status":"publish","type":"post","link":"https:\/\/elixirmedical.com\/id\/principal-clinical-research-associate-in-house-principal-cra\/","title":{"rendered":"Principal Clinical Research Associate (In-House Principal CRA)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"16062\" class=\"elementor elementor-16062\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-42dd510a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"42dd510a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-4e86aaec\" data-id=\"4e86aaec\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7b9b726 elementor-widget elementor-widget-heading\" data-id=\"7b9b726\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Major Duties and Responsibilities\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c48d581 elementor-widget elementor-widget-text-editor\" data-id=\"c48d581\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Responsibilities will include, but not be limited to:<\/p><ul><li>Develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies<\/li><li>In-house monitoring to study and procedure instructions of CRF\u2019s and study regulatory files<\/li><li>Support Clinical staff for audit readiness and preparations<\/li><li>Review study processes and documentation for GDP, GCP, and regulatory compliance<\/li><li>Maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information, etc. Duties include electronic and\/or hardcopy file maintenance<\/li><li>Monitor and tracks site and subject enrollment, track milestones and manage trial invoices<\/li><li>Prepares study site and in-house materials and meeting arrangements for study and site initiations, investigator meetings and other study meetings<\/li><li>Prepares and provides materials for vendor\/contractor training, including meeting arrangements, conduct and documentation<\/li><li>Supports Inventory Administration including all documentation for shipping, receiving and returned goods<\/li><li>Supports data management activities in CRF development, validation and verification rules and other reporting\/analysis activities, reimbursement for sites and preparation of CEC and DMSB materials<\/li><li>Manages other In-House CRAs or provides mentorship, as assigned<\/li><li>Supports department activities as required<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f4fb46 elementor-widget elementor-widget-heading\" data-id=\"3f4fb46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Qualifications\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3bc75e6 elementor-widget elementor-widget-text-editor\" data-id=\"3bc75e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Experience<\/p><ul><li>7+ years in the role of Clinical Research Associate supporting Clinical trials of all phases, medical device trial experience strongly preferred<\/li><li>Ability to be primary \/ lead in-house clinical contact for a project<\/li><li>Working knowledge of Medical Terminology, FDA and MDR regulations, and ICH GCP guidelines<\/li><li>Working auditing and self-auditing skills<\/li><li>Excellent verbal and written communication skills<\/li><li>Ability to handle multiple tasks with competing priorities<\/li><li>Proficiency with Microsoft Office suite of applications (Word, Excel and PowerPoint)<\/li><li>Prior experience with Electronic Data Capture (EDC) systems<\/li><li>Minimal Travel to headquarters on an ad-hoc basis<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3586d2 elementor-widget elementor-widget-heading\" data-id=\"b3586d2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Education Requirements\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c09037 elementor-widget elementor-widget-text-editor\" data-id=\"2c09037\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Bachelor\u2019s degree or higher in a life sciences discipline preferred<\/li><li>CCRA preferred<\/li><\/ul><p>\u00a0<\/p><p>The salary range is $125K to $135K based on factors including geographic location, experience, skills, etc.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-14406c9 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"14406c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"\/careers\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Layer_1\" x=\"0px\" y=\"0px\" viewBox=\"0 0 24 24\" style=\"enable-background:new 0 0 24 24;\" xml:space=\"preserve\"><style type=\"text\/css\">\t.st0{fill:none;stroke:#FFFFFF;stroke-width:2;stroke-linecap:round;stroke-linejoin:round;}<\/style><path class=\"st0\" d=\"M7,17l9.2-9.2 M17,17V7H7\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">View All Open Positions<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-696c8ee\" data-id=\"696c8ee\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9a8d29c elementor-widget elementor-widget-heading\" data-id=\"9a8d29c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Apply Now<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-182925e elementor-widget elementor-widget-html\" data-id=\"182925e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<iframe width=\"900\" height=\"1400\" src=\"https:\/\/app.smartsheet.com\/b\/form\/df0c19a775514859a594067b853bb0da\"><\/iframe>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Major Duties and Responsibilities Responsibilities will include, but not be limited to: Develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies In-house monitoring to study and procedure instructions of CRF\u2019s and study regulatory files Support Clinical staff for audit readiness and preparations [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[66,68],"tags":[75],"class_list":["post-16062","post","type-post","status-publish","format-standard","hentry","category-careers","category-clinical","tag-careers"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Principal Clinical Research Associate (In-House Principal CRA) - Elixir Medical Careers<\/title>\n<meta name=\"description\" content=\"This team member develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies\" \/>\n<meta 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