Training Courses - Core Cirriculum

Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.

Clinical Project Management: Intermediate

Upcoming Courses

Course Description

The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

Learning Objectives

  • Define a more strategic approach to management
  • Assess trial design decisions
  • Define best practices
  • Recognize the use and abuse of metrics
  • Implement resource planning techniques
  • Implement risk management techniques
  • Design approaches to optimize site selection
  • Evaluate techniques to enhance patient recruitment and retention
  • Cite new issues and technologies in project management

Who Should Attend

  • Clinical Project Managers who have mastered project management basics
  • Experienced Project Managers with limited drug development or clinical trial experience
  • Team Leaders or Managers with a basic knowledge of clinical project management
  • Staff from pharma, biotech or CROs who wish to learn more about the clinical trial process
  • Clinical, Regulatory and Development staff who design clinical trial programs

Instructor

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

Marla Hoelle, R.N, B.S.N., C.C.R.A, P.M.P.

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Strategic Planning and Development: Goals; design; strategy; anticipating
  • Trial Design: Study objectives; endpoints; data collection; quality; study populations; protocol
  • Resourcing: Sponsors; CROs; forecasting needs; planning
  • Risk Management: Process planning; identification; analysis; response; monitoring and control; tools
  • Best Practices and Project Management Tools: Standardizing data collection; benchmarking; tools

Day 2: 8:30 a.m. – 5:00 p.m.

  • Managing Performance and Improving Outcomes: Metrics; issues; analysis; reporting; standardization
  • Investigator Performance: Identifying; performance
  • Patient Recruitment and Retention: Identifying; techniques; minority enrollment; retention
  • Conduct of International Trials: Culture; diversity; logistics; financial issues; recruitment; international guidelines

Interactive Activities

  • Identifying the Issues
  • Risk Management Planning
  • Challenges in Conducting Global Clinical Research

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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.

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Accreditation Information

ACPE LogoBarnett 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# 0778-0000-15-042-L01-P. Released: 8/15.

Hold this course at your company!

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