SEARCH


UPCOMING LIVE SEMINARS
 






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

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description 

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. 

Learning Objectives 

  • 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 

Who Should Attend 

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

Instructor 

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 

Course Outline 

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 

Interactive Activities 

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

 

Registration Fees 

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. 

Click here for our seminar cancellation policy 

Accreditation Information 

ACPE LogoBarnett 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. 

FOLLOW US ON: 

LinkedIn twitter Facebook 


On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

Jan - July 2014 Edition

Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

BCP Cover

Download Today! 

 

 

 


 

DVD IconWEB SEMINAR ARCHIVE 

 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)