{"product_id":"15-hour-clinical-trial-assistant-fundamentals-training-program-2026-11-12","title":"15-Hour Clinical Trial Assistant Fundamentals Training Program","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe 15-hour Clinical Trial Assistant Fundamentals Program 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. This course provides CTAs information regarding the drug and medical device development and approval process. Best practice techniques for collecting and managing essential documentation stored in the sponsor's Trial Master File are covered in detail. Activities such as knowledge checks, case scenarios, and simulation exercises reviewing essential documentation for correctness and completeness provide the learner with a hands-on opportunity to apply knowledge gained from the course in their daily roles.\u003c\/p\u003e\u003cp\u003ePrior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass a final exam. Upon completion of the exam, CEU certificates will be provided.\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 of 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 \u003cli\u003eExplain how FDA inspections are conducted at the sponsor and investigative sites \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: FDA Regulations and ICH GCP\u003c\/li\u003e \u003cli\u003eModule 2: Roles and Responsibilities of the Clinical Research Team\u003c\/li\u003e \u003cli\u003eModule 3: Investigational Product Development: Drug and Medical Device Approval Process, Importance of Investigational Accountability and Issue Management\u003c\/li\u003e \u003cli\u003eModule 4: Essential Documentation and the Trial Master File: Set Up, Maintenance, and Management\u003c\/li\u003e \u003cli\u003eModule 5: Simulation Exercise Case Study: Review of Essential Documentation Forms for Completeness and Acceptance\u003c\/li\u003e \u003cli\u003eModule 6: Review of Simulation Exercise Study and FDA Inspections and Preparedness\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\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp class=\"abstract\"\u003e\u003cspan class=\"bold\"\u003eWhat participants say about Barnett's 10-Week courses ...\u003c\/span\u003e \u003c\/p\u003e\u003cp\u003e\"Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.\"\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e\"This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!\"\u003c\/p\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\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\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\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e \u003c\/b\u003e \u003c\/span\u003e \u003c\/p\u003e\u003cp\u003eTwo 2.5 hours classes\/week for 3 weeks.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,695 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,895 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\u003c\/p\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 final exam and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-24-008-L99-P. Released: 4\/24.\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 \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375370002797,"sku":"BI17497","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375370035565,"sku":"BI17497-ACADEMIC","price":1695.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/15-hour-clinical-trial-assistant-fundamentals-training-program-2026-11-12","provider":"Barnett International ","version":"1.0","type":"link"}