Study Site Start-Up: Opening and Managing a Successful Clinical Research Site

The role of the clinical research site is vital in the success of the clinical trial process. The research site is the key conductor of studies, and quality research sites are in great demand in the current research environment. This course presents the core ingredients with explanation, tools and examples for a successful research site. Case scenarios will be presented throughout the course for study and benchmarking practices that lead to high performance and successful businesses.

• Identify components of a successful research site through benchmarking elite performers
• Identify the primary elements of business and marketing planning for a research site
• Review research site GCP responsibilities
• Recognize essential content of clinical research site SOPs
• Describe the staffing needs of research sites and review various models
• Review the process of contract and budget negotiations and content
• Describe the process of conducting project feasibility
• Identify effective approaches to subject recruitment
• Implement quality systems promoting audit readiness

• Research Site Managers/Directors
• Clinical Research Coordinators
• Principal Investigators
• Research Consultants
• Entrepreneurs

The course will be led by one of the following instructors:

Lily Romero, P.A., C.C.R.C.

Jackie Stader, C.O.T., C.C.R.C.

Click here for complete trainer biographies

Day 1: 8:30 a.m. – 5:00 p.m.

• Demonstrated Keys to Success for Research Sites:  Benchmarking successful site practices; case scenario of the successful research site
• Business Planning: Stakeholder buy-in and support; incorporating; liability insurance; vision and mission statements; objectives and goals
• Site GCP Responsibilities: ICH GCP E6; FDA regulations 21 CFR Parts 11, 50, 54, 56; drug/biologic 21 CFR Part 312; device and combinations 21 CFR Parts 3 & 812; other GCPs, state laws and HIPAA; NIH studies, The Common Rule 45 CFR Part 46 Human Subject Protections Government Funded Research; other best practices
• Content of Clinical Research SOPs: Components; training and implementation; measuring compliance
  Staffing: Design of department: facilities and management models; key players; credentialing; national average salaries
• Marketing a Research Site: How; to whom: customers (sponsors, participants and FDA); when; healing a bruised reputation; PR
• Contracts & Budget: Negotiating; contract language; budget components; essentials to include; legal review
• Project Feasibility: What it takes to run a successful study; completing a study feasibility; risk factor analysis and management
• Subject Recruitment: Identifying accurate potential subject numbers; methods and strategies; formal recruitment plans
• Quality Systems and Audit Readiness: FDA inspection program and site deficiencies; quality system components; establishing audit readiness
• Performance Improvement: How to keep your site on top; evaluation and improving never ends; conflict resolution; root cause analysis and effective interventions; changing with the times

• Simulations/Scenarios
• Pre- and Post-Tests
• Case Scenario: Used Throughout the Course to Apply the Information to Promote Increased Understanding

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-093-L01-P. Released 10/12.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.