{"product_id":"clinical-trial-assistant-fundamentals-2026-10-27","title":"Clinical Trial Assistant Fundamentals","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis course focuses on the responsibilities of the Clinical Trial Assistant or Associate (CTA), a key administrative member of a project team at the sponsor or CRO. It will start by providing the foundational knowledge of how drugs and medical devices are developed and approved, and the importance of ICH GCP and FDA regulations in the conduct of clinical trials. From there, the various roles and responsibilities of the clinical research team will be introduced, followed by a discussion of the importance of the CTA role in daily administrative operations of clinical trials. Responsibilities the CTA provides to the clinical trial team will be reviewed in depth, which include the following: Study start-up, maintenance, and closure, essential documentation tracking and management using the Trial Master File, distribution and management of adequate studies supplies (e.g., investigational product, laboratory kits, and other items used by the investigative site), reconciliation of documentation, coordination of team meetings, management and updating of study trackers, and the creation of documentation used in clinical trials (e.g., regulatory binder, newsletters).\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eReview FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practice (GCP)\u003c\/li\u003e \u003cli\u003eDescribe the role the Clinical Trial Assistant and other team members in clinical research\u003c\/li\u003e \u003cli\u003eDescribe the investigational product development process: Drug and device\u003c\/li\u003e \u003cli\u003eList essential documentation required in the conduct of clinical research\u003c\/li\u003e \u003cli\u003eDescribe the Trial Master File\u003c\/li\u003e \u003cli\u003eDevelop tracking tools used in clinical research\u003c\/li\u003e \u003cli\u003eDefine investigational product management and accountability in clinical research\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Trial Associates\u003c\/li\u003e \u003cli\u003eClinical Trial Assistants\u003c\/li\u003e \u003cli\u003eClinical Coordinators at the sponsor or CRO\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\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\"\u003eModule 1:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eICH GCP and FDA Regulations\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 2:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRoles and Responsibilities of the Clinical Research Team\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 3:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eInvestigational Product Development: Drug and Device Approval Process\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 4:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eInvestigational Product: Accountability, Management, and Issues Management\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay Two\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 5:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eTrial Master File: Set up, Maintain, and Manage\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 6:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eClinical Trial Start Up Process and Essential Documentation\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 7:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eClinical Trial Maintenance and Essential Documentation\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eModule 8:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eClinical Trial Close Out and Essential Documentation\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\u003eDefine Clinical Research Team Responsibilities\u003c\/li\u003e \u003cli\u003eTrial Master File Set Up Requirements\u003c\/li\u003e \u003cli\u003eReview of Essential Documentation for Completion and Acceptance: Form FDA 1572, Financial Disclosure Form, Curriculum Vitae, Medical Licensure, IRB Correspondence\u003c\/li\u003e \u003cli\u003eSimulation Exercise: Clinical Trial Start-Up, Maintenance, and Closure\u003c\/li\u003e \u003c\/ul\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 15 hours (1.5 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#: 0778-0000-25-017-L99-P. Released: 3\/25. \u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375358501229,"sku":"STFJ1026","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375358533997,"sku":"STFJ1026-ACADEMIC","price":1475.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/clinical-trial-assistant-fundamentals-2026-10-27","provider":"Barnett International ","version":"1.0","type":"link"}