{"product_id":"cra-crc-beginner-program-2026-12-09","title":"CRA \u0026 CRC: Beginner Program","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the investigational product development process\u003c\/li\u003e \u003cli\u003eReview FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practices (GCPs)\u003c\/li\u003e \u003cli\u003eDescribe the roles and responsibilities of the Clinical Research Associate and the Clinical Research Coordinator before, during, and after a clinical trial\u003c\/li\u003e \u003cli\u003eIdentify the requirements of the Investigator in supervising clinical research\u003c\/li\u003e \u003cli\u003eDiscuss the role of an Institutional Review Board, its composition, and responsibilities in the clinical trial process\u003c\/li\u003e \u003cli\u003eDefine the informed consent process, the elements of the informed consent document\u003c\/li\u003e \u003cli\u003eDescribe an overview of the different types of Monitoring Visits, including preparation, activities, and monitoring visit follow-up\u003c\/li\u003e \u003cli\u003eDefine source documents and Case Report Forms (CRFs) in relation to CRF completion and source document verification\u003c\/li\u003e \u003cli\u003eDescribe definitions related to safety management, identification of adverse events, and reporting requirements\u003c\/li\u003e \u003cli\u003eDescribe the difference between a sponsor audit and an FDA inspection and preparation\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eAspiring Clinical Research Coordinators and Nurses\u003c\/li\u003e \u003cli\u003eAspiring Clinical Research Associates - In-house or Field-based\u003c\/li\u003e \u003cli\u003eCollege Students and New Graduates in a Scientific Field\u003c\/li\u003e \u003cli\u003eNOTE: This course is also appropriate for CRAs or CRCs with less than six months experience\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSonja Cooper, Ph.D., M.B.A.\u003c\/p\u003e\u003cp\u003eJanet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.\u003c\/p\u003e\u003cp\u003eLily Romero, P.A., C.C.R.C.\u003c\/p\u003e\u003cp\u003eElizabeth Weeks-Rowe, LVN, C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eIntroduction to Clinical Research\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eClinical Research Team:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRoles \u0026amp; Responsibilities\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInvestigational Product (IP) Development\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eGood Clinical Practice:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eFDA Regulations, FDA Guidance, and ICH GCP E6 Guideline\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eThe Clinical Study Protocol and Study Feasibility\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eThe Principal Investigator, Site Selection, and Study Initiation\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInstitutional Review Board, the Consent of Human Volunteers, and HIPAA\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eSafety Reporting:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDefinitions \u0026amp; Reporting Requirements\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Three\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eIP Accountability, Essential Documents, and Routine Monitoring Visits\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eSource Document Verification, Data Management, and the Trial Close-out Visit\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInteractive Exercises I and II:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eCRF completion and monitoring simulation exercises\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eRegulatory Compliance \u0026amp; Quality Assurance:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eAudits \u0026amp; Inspections\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eCase Study Reviews - Adverse Events, Protocol Modifications, Study Feasibility, Informed Consent and Monitoring Visit Scenarios\u003c\/li\u003e \u003cli\u003eSite Selection, IP Accountability, Source Document Verification and Case Report Form Exercises\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e \u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cdiv\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/div\u003e\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\u003cdiv\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e \u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e \u003c\/div\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 22.5 hours (2.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-019-L99-P. Released: 3\/25. \u003c\/p\u003e\u003cp\u003e\u003cfont color=\"inherit\" face=\"inherit\" size=\"-1\"\u003e Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/font\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cb\u003e \u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375361614189,"sku":"SCOM1226","price":1995.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375361646957,"sku":"SCOM1226-ACADEMIC","price":1575.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/cra-crc-beginner-program-2026-12-09","provider":"Barnett International ","version":"1.0","type":"link"}