Identifying and Closing the Training Gap in Clinical Research
Sponsors of clinical trials – and organizations that execute clinical trials – consistently identify the need for well trained and qualified people at all levels to execute studies. Fast-paced clinical trials and the pressures to quickly and effectively meet project milestones can be overwhelming. Furthermore, there is no “best practice” out there for closing the gaps in training programs. Many who are charged with ensuring trained and qualified staff are new to the world of training, and may have little to no formal education on how to design and deliver effective instruction. Now that industry has newly-identified standards for clinical research competencies that add value to training programs in organizations of all sizes, effective delivery of such information is still lacking.
Until training goes beyond tracking the reading of SOPs, issues with quality and performance will plague clinical trial execution. Fortunately, there are options which will allow you to staff a highly-trained and effective clinical team.
This 90-minute course will give you practical ideas related to leading an exceptional clinical research training program. Course content will answer the following questions:
- What should I do to identify the training needs, and how do I prioritize what to do first?
- How do I design a curriculum to go beyond SOP training?
- What are some of the options for program delivery and how should I evaluate them?
After attending this interactive live session, you will be able to:
- Use newly-developed standards for clinical research competencies to identify the gaps in your organization’s skills
- Identify the right programs to close those gaps, applying principles of adult learning to evaluate content
- Discuss the landscape of program options and list the steps to select and engage training vendors
This course will be of benefit to anyone working in a clinical/GCP regulated environment on a global or domestic scale. Those with responsibility for training - including providing training, overseeing others who provide training, or for the training department in a GMP regulated environment will find this course extremely beneficial. Attendance is also recommended for those who are actively involved in performing, overseeing, auditing, or managing training as a function or as an operational responsibility.
Laurie Halloran, BSN founded Halloran Consulting Group in 1998. With over 25 years of experience in clinical affairs management with contract research organizations and biotechnology companies, Laurie is recognized as an industry expert in improving the organizational effectiveness of clinical research programs with a specialty in gap analysis and strategic planning. Laurie has managed 25+ clinical trials from Phase I to Phase III for both emerging and established companies and has managed operational budgets of up to $24 MM.
Prior to founding Halloran, Laurie spent 10 years at PAREXEL International where she developed worldwide training capabilities with the clinical operations group. She has also established clinical operations at OXiGENE and Antigenics.
Laurie is an adjunct professor at Boston University Medical School and lectures at the Tufts Center for Drug Development Post-Graduate program. She has previously taught at George Washington University and Harvard University. In 2010, Laurie was selected as one of the 100 Most Inspiring People in Life Science by PharmaVoice and in 2009 was awarded Clinical Researcher of the Year by the New England Chapter of the Associate of Clinical Research Professionals.