{"id":3032,"date":"2024-02-06T16:55:41","date_gmt":"2024-02-06T21:55:41","guid":{"rendered":"https:\/\/www.med.unc.edu\/unccra\/?page_id=3032"},"modified":"2025-09-22T16:13:42","modified_gmt":"2025-09-22T20:13:42","slug":"capabilities","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/unccra\/capabilities\/","title":{"rendered":"Capabilities"},"content":{"rendered":"<script>\n\n    (function($) {\n        $(\"body, html\").addClass(\"heels_full_width_overflow\");\n    })(jQuery);\n\n   <\/script>\n   <div style=\"background-color:#FFFFFF; background-image: url(https:\/\/www.med.unc.edu\/unccra\/wp-content\/uploads\/sites\/1352\/2024\/12\/CRA-Capabilities-Hero-scaled.jpg);\" data-speed=\"18\" id=\"parallax-section\" data-type=\"background\" class=\"full-width-contained whitebackground capabilities section-hero\">\n<h1>CRA Capabilities<\/h1>\n<p>Coordinating research from proposal to publication<\/p>\n<\/div>\n<script>\n\n    (function($) {\n        $(\"body, html\").addClass(\"heels_full_width_overflow\");\n    })(jQuery);\n\n   <\/script>\n   <div style=\"background-color:#E2EFF8;\" class=\"full-width-contained whitebackground capabilities\">\n\n<div class=\"\tstrengthening-clinical-research title-sub-content title-yellow-line\t\">\n\t <div class=\"row  oscitas-bootstrap-container\"><div class=\"col-lg-6 col-md-6 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<h2>We are strengthening the clinical research infrastructure of UNC<\/h2>\n<\/div>\n<div class=\"col-lg-6 col-md-6 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\nThe Clinical Research Alliance (CRA) is uniquely situated in the UNC School of Medicine (SOM) to build research collaborations between our patients, exceptional physicians, investigators, research staff, and community partners. We leverage the full power of our Alliance to streamline clinical trials and improve the development process of life-changing science.\u00a0<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<div class=\"row stats-row oscitas-bootstrap-container\"><div class=\"col-lg-3 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tstats-num\t\">\n\t 9th\n<\/div>\n<p>UNC is ranked 9th nationally for research<\/p>\n<\/div>\n<div class=\"col-lg-3 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tstats-num-second\t\">\n\t $1.55B\n<\/div>\n<p>UNC is awarded $1.55B in research funding annually<\/p>\n<\/div>\n<div class=\"col-lg-3 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tstats-num\t\">\n\t $650M\n<\/div>\n<p>Of UNC&#8217;s annual funding, $650M is allocated to the School of Medicine<\/p>\n<\/div>\n<div class=\"col-lg-3 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tstats-num-last\t\">\n\t 50+\n<\/div>\n<p>50+ research centers, cores, and institutes<\/p>\n<\/div><\/div><\/div>\n<script>\n\n    (function($) {\n        $(\"body, html\").addClass(\"heels_full_width_overflow\");\n    })(jQuery);\n\n   <\/script>\n   <div style=\"background-color:#ffffff;\" class=\"full-width-contained whitebackground capabilities capabilities-expertise\">\n\n<div class=\"\ttitle-sub-content title-blue-line\t\">\n\t \n<h2 style=\"text-align: center\">Expertise<\/h2>\n\n<\/div>\n<div class=\"row  oscitas-bootstrap-container\"><div class=\"col-lg-4 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tcapabilities-expertise-card title-sub-content\t\">\n\t \n<h4 style=\"text-align: center\">Clinical Coordinating Center<\/h4>\n<p style=\"text-align: center\">The CRA enables physician researchers to coordinate multi-center trials as principal investigators. We are skilled at subcontracting with domestic and international sites in order to swiftly enroll participants around the world. Our contracting expertise ensures services and resources from vendors to successfully and efficiently implement trials.<\/p>\n\n<\/div><\/div>\n<div class=\"col-lg-4 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tcapabilities-expertise-card title-sub-content\t\">\n\t \n<h4 style=\"text-align: center\">Researchers<\/h4>\n<p style=\"text-align: center\">We bring researchers from different disciplines together to develop studies that consider all populations, and leverage the expertise within UNC Health and the University, including the\u00a0<a href=\"https:\/\/tracs.unc.edu\/\" rel=\"noopener\">NC Translational and Clinical Sciences Institute (NC TraCS)<\/a>.<\/p>\n\n<\/div><\/div>\n<div class=\"col-lg-4 col-md-6 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n\n<div class=\"\tcapabilities-expertise-card sponsors title-sub-content\t\">\n\t \n<h4 style=\"text-align: center\">Sponsors<\/h4>\n<p style=\"text-align: center\">The CRA works with government, industry, and foundation sponsors to answer important research questions.<\/p>\n\n<\/div><\/div><\/div><\/div>\n<script>\n\n    (function($) {\n        $(\"body, html\").addClass(\"heels_full_width_overflow\");\n    })(jQuery);\n\n   <\/script>\n   <div style=\"background-color:#4B9CD3;\" class=\"full-width-contained whitebackground capabilities capabilities-testimonial\">\n\n<div class=\"\tcapabilities-testimonial-inner title-sub-content title-yellow-line\t\">\n\t \n<h2 style=\"text-align: center\">Testimonial<\/h2>\n<p style=\"text-align: center\">&#8220;I began working with the CRA in the fall of 2024. I had an idea for a clinical trial, but did not have the experience to know the next steps to take. That is where the CRA came in! We worked closely together for the next 3 months to identify a funding mechanism, identify necessary co-investigators, and ultimately write the grant. The CRA made the process as easy as possible. Even more impressive, they went above-and-beyond to work around my busy clinical schedule as we met to put the grant together. I cannot say enough great things about the CRA and working with them.&#8221;<\/p>\n<h4 style=\"text-align: center\">&#8211;\u00a0 Matthew Q. Miller, MD<\/h4>\n<p class=\"testimonial-person-title\" style=\"text-align: center\">Director, UNC Facial Nerve Center<br \/>\n<a href=\"https:\/\/www.med.unc.edu\/ent\/facialnervecenter\/\" target=\"_blank\">UNC Facial Nerve Center<\/a><br \/>\n<a href=\"https:\/\/www.facebook.com\/UNC-Facial-Nerve-Center-108854161640064\" target=\"_blank\">UNC Facial Nerve Center Facebook<\/a>\n<\/div><\/div>\n<script>\n\n    (function($) {\n        $(\"body, html\").addClass(\"heels_full_width_overflow\");\n    })(jQuery);\n\n   <\/script>\n   <div style=\"background-color:#ffffff;\" class=\"full-width-contained whitebackground capabilities title-sub-content title-yellow-line\">\n<h2>Clinical Trial Coordination Services<\/h2>\n<p>The CRA provides resources to facilitate clinical research management and oversight on behalf of sponsor organizations or individual investigators. Our capabilities encompass all aspects of multi-site clinical trial coordination.<\/p>\n<p>&nbsp;<\/p>\n<div role=\"tablist\" class=\"panel-group  oscitas-bootstrap-container\" id=\"unc-accordion-0\">\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-0\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-0\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-0\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-0\">\n                Business Development            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-0\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">Our Business Development team expertly navigates the complex university systems, as well as relationships with businesses, funders, and industry partners to prepare compelling pitches and proposals. In addition, our team strategically assesses the funding landscape, potential partners, and funding mechanisms to optimize research funding opportunities. Our team works with stakeholders to identify clinical sites as well as to coordinate budget and proposal development to ensure accurate and timely submissions.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-1\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-1\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-1\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-1\">\n                Clinical Operations            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-1\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">\n<strong>Program Management<\/strong><br \/>\nOur program managers excel at navigating UNC\u2019s vast network of resources, sites, sponsor research operations, and administrative processes to integrate complex study procedures while meeting milestones and producing quality data and results.<\/p>\n<p><strong>Trial Operations and Site Monitoring<\/strong><br \/>\nOur team trains and provides support for clinical site staff, facilitates communication, develops and implements recruitment and retention strategies, and incorporates protocol amendments. We also work with biorepositories, labs, and imaging reading centers to ensure protocol compliance and quality assurance. Site monitors conduct site initiation, intermittent monitoring, and trial close-out visits to ensure compliance with protocol, participant safety, and data quality.<\/p>\n<p><strong>Clinical Coordination<\/strong><\/p>\n<p>Our team works with sponsor, network, and trial leadership to plan scheduling and logistics for virtual and in-person meetings, facilitate communication, provide documentation, keep records, and support manuscript development and tracking.<\/p>\n<p><strong>Data Operations and Analytics<\/strong><\/p>\n<p>Within the CRA and through our established partnerships, we offer 21 CFR Part 11 compliant data capture, accrual tracking, trial master file data management, clinical data, and program management systems and support. Our team of data management experts develop case report forms and create site performance reports and dashboards, as well as reports for sponsors and network leadership.<\/p>\n<p><strong>Medical Affairs<\/strong><\/p>\n<p>The CRA\u2019s Medical Affairs team designs protocols, interprets data, and communicates with stakeholders to ensure the scientific integrity and strategic alignment of clinical trials.<\/p>\n<p><strong>IDS<\/strong><\/p>\n<p>The CRA partners with proven Investigational Drug Services (IDS) entities to manage the formulation, labeling, packaging, and dispensing of investigational drugs and placebos used in clinical trials. We ensure compliance with regulatory standards and protocols, including inventory tracking, shipping, storage, and dispensing.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-2\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-2\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-2\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-2\">\n                Contracting Services            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-2\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">We have dedicated personnel to coordinate agreements across institutional offices and push legal documents over the finish line. Our services include the development, review, and negotiation of master services, clinical trial, data use, material transfer, data confidentiality agreements, and all supporting documents in collaboration with UNC procurement offices and the <a href=\"https:\/\/osp.unc.edu\/\">Office of Sponsored Programs<\/a>.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-3\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-3\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-3\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-3\">\n                Financial Services            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-3\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">The CRA has dedicated resources from the <a href=\"https:\/\/www.med.unc.edu\/fbo\/first\/\">UNC SOM Finance &amp; Research Support Team (FiRST)<\/a> to provide comprehensive financial services from strategy to execution. This includes managing budgets, establishing site subagreements, ensuring compliance with financial regulations, and optimizing financial processes for large-scale clinical trials that often involve multiple funding sources, intricate financial reporting requirements, and the need for strategic financial planning.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-4\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-4\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-4\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-4\">\n                Regulatory &amp; Compliance            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-4\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">The CRA Regulatory team assists in providing strategic guidance for FDA and sIRB submissions, including coordinating initial submissions and reliance agreements, and providing ongoing support to ensure compliance through the life of the protocol.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-5\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-5\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-5\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-5\">\n                Scientific Writing            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-5\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">Our Scientific Writing group and operations staff assist with the development of grant proposals, trial protocols, manuals of operations, investigator&#8217;s brochures, recruitment materials, and other documentation. Additionally, we provide support for dissemination of findings through abstracts and manuscripts.<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-6\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h4 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-6\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-6\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-6\">\n                Technology Solutions            <\/button>\n\n        <\/h4>\n\n    <\/div>\n\n    <div id=\"details-0-6\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">The CRA has dedicated technology specialists who have expertise in clinical trial apps, management software, and reporting dashboards used by both academia and industry. Our team provides documentation and training to sites and other users and is available for direct support.<\/div>\n\n    <\/div>\n        \n<\/div><\/div><\/div>\n<script>\n\n    (function($) {\n        $(\"body, html\").addClass(\"heels_full_width_overflow\");\n    })(jQuery);\n\n   <\/script>\n   <div style=\"background-color:#13294B;\" class=\"full-width-contained whitebackground cra-footer\"><div class=\"row  oscitas-bootstrap-container\"><div class=\"col-lg-4 col-md-12 col-xs-12 col-sm-12 oscitas-bootstrap-container\">\n<p>Get to Know Us<\/p>\n<\/div><\/div>\n<div class=\"row  oscitas-bootstrap-container\"><div class=\"col-lg-3 col-md-3 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n<a class=\"btn btn-primary btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"https:\/\/www.med.unc.edu\/unccra\/the-cra-team\/\">Meet the Team <i class=\"glyphicon glyphicon-arrow-right\" ><\/i><\/a>\n<\/div>\n<div class=\"col-lg-3 col-md-3 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n<a class=\"btn btn-primary btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"https:\/\/www.med.unc.edu\/unccra\/careers\/\">Explore Careers <i class=\"glyphicon glyphicon-arrow-right\" ><\/i><\/a>\n<\/div>\n<div class=\"col-lg-3 col-md-3 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n<a class=\"btn btn-primary btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"https:\/\/www.med.unc.edu\/unccra\/collaborate-with-us\/\">Contact Us <i class=\"glyphicon glyphicon-arrow-right\" ><\/i><\/a>\n<\/div>\n<div class=\"col-lg-3 col-md-3 col-xs-12 col-sm-6 oscitas-bootstrap-container\">\n<a class=\"btn btn-primary btn-lg btn-block  oscitas-bootstrap-container\" target=\"_self\" href=\"https:\/\/www.linkedin.com\/company\/unc-clinical-research-alliance\/\">LinkedIn <i class=\"glyphicon glyphicon-arrow-right\" ><\/i><\/a><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":116266,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/front-page.php","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-3032","page","type-page","status-publish","hentry","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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