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Clinical Trials Curriculum

Courses in the Clinical Trials Management and Regulatory Compliance certificate use real-world clinical trials case studies to reinforce the foundational clinical trials knowledge that will accelerate your career in clinical research. The goals of the Clinical Trials program are that every learner will effectively:

  • Understand the entire clinical trials process, from the perspective of the clinical study site and the sponsor or monitor
  • Consider and maintain regulatory compliance practices and the ethical considerations of conducting clinical research
  • Initiate clinical research studies, apply monitoring methods, and write documents and reports

Classes are available both online and in-person at the Gleacher Center in downtown Chicago.

Clinical Trials Program Structure

  • Five required courses and one elective
  • Students can complete the certificate in as little as three quarters
  • Class sizes are small, ranging from 10-20 students per course
  • Tuition for each course is $1,300

 

Clinical Trials courses

Online and In-Person Class Formats

Classes are offered in two formats: online or in-person. Students may take all courses online or enroll in a combination of online and in-person courses.

Online In-Person
3 to 5 weeks course length Courses are offered in a convenient 3-day seminar format at the University of Chicago Gleacher Center in downtown Chicago
Weekly live class sessions, offered weekday evenings and Saturday mornings Seminar schedule is Wednesday-Friday from 8:30am-4:30pm
Between the weekly synchronous sessions, participants complete required readings, assignments, and self-study activities  
Learn more about taking online courses  

Apply to the Clinical Research and Regulatory Compliance Certificate

Applications are rolling—admissions decisions are typically made within two to three weeks.

Apply

 

Click a course title to read the course description and register for the course.

Courses

Clinical Trials Management The Drug Development Process
03/27/2017 to 04/29/2017

CLIN 17200 | The Drug Development Process

This course provides an overview of the pharmaceutical industry, drug development and clinical trials processes. Topics include the economics of drug development, R&D productivity, human subject protections, inspections and audits, safety reporting and clinical trials.

Synchronous Sessions: April 8, 15, 22, and 29 from 10:30am-12pm.

Prerequisite(s):
none
Instructor:
Melissa Byrn, Andrew Kucharski

Melissa Byrn

Melissa Byrn, MBE

, Director of Research Operations and Conduct for the Office of Clinical Research at the University of Chicago Medicine. Melissa has ten years of experience in research operations and oversight, including financial and administrative management, regulatory compliance, research workforce development, and compliance program enhancement. Melissa brings both industry and an academic research perspective to her work and her areas of expertise include FDA law, ICH Good Clinical Practice, medical device research, biomedical ethics, quality assurance auditing, and research process improvement analysis. Melissa obtained a master’s degree in Medical Ethics and Health Policy from the Perelman School of Medicine at the University of Pennsylvania.

,

Andrew Kucharski

Andrew Kucharski, PhD,

has over 20 years of cross-functional project management experience in drug development. As a global operations manager, he has been responsible for NDA filings in the US, Europe, and Japan. Dr. Kucharski is experienced in both clinical and medical affairs and has leveraged global teams from first-in-human trials through product launch and life-cycle management. He possesses a strong interest in pharmaco-epidemiology, pharmacovigilance, and safety signal detection. He has assumed leadership roles in developing strong alliance partnerships, designed and implemented global quality oversight programs and has significant experience in FDA mandated risk evaluation and mitigation strategies. Dr. Kucharski is a sought after presenter at scientific meetings, a published author whose work appears in high impact peer review journals, and has been a guest speaker at U.S. FDA. A trained innovation and change management coach, Dr. Kucharski’s personal mission is to foster talent and mentor individual development. He holds a PhD in Epidemiology focusing on serum secosteroid levels as a risk factor for health disparities.

 

Course Code: CLIN 17200
Section: 17S7
Location: Online
Dates:
Mar 27 to Apr 29
Tuition: $1,300.00
Days/Times:



Online Registration Close Date:
March 17, 2017
Online registration closes at 11:59 PM the day before the posted close date.

CLIN 17200 | The Drug Development Process

This course provides an overview of the pharmaceutical industry, drug development and clinical trials processes. Topics include the economics of drug development, R&D productivity, human subject protections, inspections and audits, safety reporting and clinical trials.

Synchronous Sessions: April 8, 15, 22, and 29 from 10:30am-12pm.

Prerequisite(s):
none
Instructor:
Melissa Byrn, Andrew Kucharski

Melissa Byrn

Melissa Byrn, MBE

, Director of Research Operations and Conduct for the Office of Clinical Research at the University of Chicago Medicine. Melissa has ten years of experience in research operations and oversight, including financial and administrative management, regulatory compliance, research workforce development, and compliance program enhancement. Melissa brings both industry and an academic research perspective to her work and her areas of expertise include FDA law, ICH Good Clinical Practice, medical device research, biomedical ethics, quality assurance auditing, and research process improvement analysis. Melissa obtained a master’s degree in Medical Ethics and Health Policy from the Perelman School of Medicine at the University of Pennsylvania.

,

Andrew Kucharski

Andrew Kucharski, PhD,

has over 20 years of cross-functional project management experience in drug development. As a global operations manager, he has been responsible for NDA filings in the US, Europe, and Japan. Dr. Kucharski is experienced in both clinical and medical affairs and has leveraged global teams from first-in-human trials through product launch and life-cycle management. He possesses a strong interest in pharmaco-epidemiology, pharmacovigilance, and safety signal detection. He has assumed leadership roles in developing strong alliance partnerships, designed and implemented global quality oversight programs and has significant experience in FDA mandated risk evaluation and mitigation strategies. Dr. Kucharski is a sought after presenter at scientific meetings, a published author whose work appears in high impact peer review journals, and has been a guest speaker at U.S. FDA. A trained innovation and change management coach, Dr. Kucharski’s personal mission is to foster talent and mentor individual development. He holds a PhD in Epidemiology focusing on serum secosteroid levels as a risk factor for health disparities.

 

Course Code: CLIN 17200
Section: 17S7
Location: Online
Dates:
Mar 27 to Apr 29
Tuition: $1,300.00
Days/Times:



Online Registration Close Date:
March 17, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Fraud and Misconduct
04/3/2017 to 05/4/2017

CLIN 27100 | Fraud and Misconduct

This course will provide an overview of clinical research-related fraud and scientific misconduct. Students are introduced to topics which include the identification of suspected fraud and misconduct, significant cases that shaped the definition of clinical research-related fraud, recent regulatory changes, and the clinical research professional’s role in the identification and reporting of suspected fraud and misconduct. Students will gain an understanding of the various acts that define fraud and misconduct and the impact that they have on the clinical research process. At the conclusion of the course, students will present a recent fraud and/or misconduct case study to the class.

Synchronous Sessions: April 13, 20, 27, and May 4 from 6-8:00 PM.

Prerequisite(s):
none
Instructor:
Pamela Mason

Pamela Mason

Pamela Mason, MPH,

is an experienced quality manager, auditor, course developer, instructor, and consultant who brings with her over 16 years of experience in the areas of clinical research, compliance, auditing, training, and quality assurance. Pam is also both an ASQ Certified Quality Auditor as well as an ASQ Certified Quality Manager. Pam is currently VP of Mason Professional Services, LLC and an Adjunct Faculty member for Northwestern University’s Masters Program in Quality Assurance and Regulatory Science.

Course Code: CLIN 27100
Section: 17S7
Location: Online
Dates:
Apr 03 to May 04
Tuition: $1,300.00
Days/Times:



Online Registration Close Date:
March 23, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Good Clinical Practices
05/11/2017 to 05/13/2017

CLIN 11100 | Good Clinical Practices

This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.

Prerequisite(s):
none
Instructor:
Sheri Smith

Sheri Smith

Sheri Smith, MS,

has over 25 years of clinical trial experience in the pharmaceutical and medical device industry. Sheri currently serves as president of Courante Oncology, a specialty consulting company that provides customized clinical research consulting and services to companies that are developing new products for the treatment of patients with cancer. Her previous positions include clinical operations, project management, clinical research associate and clinical statistician so she brings a broad range of experience in the conduct/execution of clinical trials, as well as the associated data collection and analysis. She has been intricately involved with numerous IND/NDA/PMA submissions and has been a clinical reviewer on product due diligence teams for multiple companies. Sheri has an undergraduate degree in biology and a Master’s degree in statistics.

Course Code: CLIN 11100
Section: 17S1
Location: Gleacher Center
Dates:
May 11 to May 13
Tuition: $1,300.00
Days/Times: Thu
8:30 AM–4:30 PM
Fri
8:30 AM–4:30 PM
Sat
8:30 AM–4:30 PM

Unlimited slots available

Online Registration Close Date:
May 5, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Fundamentals of Clinical Monitoring
05/15/2017 to 06/10/2017

CLIN 17500 | Fundamentals of Clinical Monitoring

This course introduces students to the processes and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization from the site-initiation visit to the closing out of a clinical study.

Sync. sessions: May 27 & June 3, 10 from 10:30am to Noon.

Prerequisite(s):

Good Clinical Practices and The Drug Development Process

Instructor:
Lauren Wall

Lauren Wall

Lauren Wall, MS,

has over 10 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. Lauren currently oversees the clinical research operations in the section of Hematology Oncology at the University of Chicago. Her primary responsibilities include planning, organizing, directing, and overseeing daily clinical research operations for over 300+ clinical trials. Prior to taking her role in the academic setting, Lauren worked at an Oncology CRO where she gained experience in clinical trial monitoring and project management. In addition, Lauren traveled to several NCI designated cancer centers to conduct site visit audits. Lauren holds an MSc degree in Clinical Research Administration from the George Washington University. Lauren has a strong passion for teaching and mentoring others about the exciting career opportunities in the field of clinical research.

Course Code: CLIN 17500
Section: 17S7
Location: Online
Dates:
May 15 to Jun 10
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
May 5, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Project Management and Leadership in the Healthcare Industry
05/31/2017 to 06/2/2017

CLIN 21200 | Project Management and Leadership in the Healthcare Industry

This course focuses on advanced strategic, operational, and project management topics in clinical research with an emphasis on increasing efficiency and quality at all levels of the process. Topics include allocating staff and resources effectively; assessing financial and regulatory implications from a business perspective; developing, negotiating, and managing comprehensive clinical trials budgets; managing timelines; and leading and motivating effective teams.

Prerequisite(s):
none
Instructor:
Clarice L. Copeman, Richard Wilson

Clarice L. Copeman

Clarice L. Copeman

has over 13 years of experience in new medical product development and has been working in project and program management for major medical device companies, in multiple therapeutic areas, for nearly 10 years. Clarice has extensive experience in all aspects of clinical strategy and clinical project development including execution, close-out, and presentation of results in both pre- and post-approval studies in multiple geographies.

,

Richard Wilson

Richard Wilson, MD,

is the co-founder of two medical product companies, EnteroMedics Inc. and ArthroScience, LLC. He has over 30 years of pharmaceutical and medical device development experience. Rich has served in leadership positions and as a consultant to medical centers and to both start-up and established international medical device and pharmaceutical companies.  Additionally, Rich has authored numerous published journal articles and abstracts and is a named inventor on many issued patents and pending patent applications. As an adjunct faculty member at the University of Chicago Graham School, he has been teaching seminars on medical team leadership and on medical product development since the late nineties. Dr. Wilson earned his MD from Northwestern University Medical School.

 

 

Course Code: CLIN 21200
Section: 17S1
Location: Gleacher Center
Dates:
May 31 to Jun 02
Tuition: $1,300.00
Days/Times: Wed
9:00 AM–4:30 PM
Thu
9:00 AM–4:30 PM
Fri
9:00 AM–4:30 PM

Unlimited slots available

Online Registration Close Date:
May 21, 2017
Online registration closes at 11:59 PM the day before the posted close date.

CLIN 21200 | Project Management and Leadership in the Healthcare Industry

This course focuses on advanced strategic, operational, and project management topics in clinical research with an emphasis on increasing efficiency and quality at all levels of the process. Topics include allocating staff and resources effectively; assessing financial and regulatory implications from a business perspective; developing, negotiating, and managing comprehensive clinical trials budgets; managing timelines; and leading and motivating effective teams.

Prerequisite(s):
none
Instructor:
Clarice L. Copeman, Richard Wilson

Clarice L. Copeman

Clarice L. Copeman

has over 13 years of experience in new medical product development and has been working in project and program management for major medical device companies, in multiple therapeutic areas, for nearly 10 years. Clarice has extensive experience in all aspects of clinical strategy and clinical project development including execution, close-out, and presentation of results in both pre- and post-approval studies in multiple geographies.

,

Richard Wilson

Richard Wilson, MD,

is the co-founder of two medical product companies, EnteroMedics Inc. and ArthroScience, LLC. He has over 30 years of pharmaceutical and medical device development experience. Rich has served in leadership positions and as a consultant to medical centers and to both start-up and established international medical device and pharmaceutical companies.  Additionally, Rich has authored numerous published journal articles and abstracts and is a named inventor on many issued patents and pending patent applications. As an adjunct faculty member at the University of Chicago Graham School, he has been teaching seminars on medical team leadership and on medical product development since the late nineties. Dr. Wilson earned his MD from Northwestern University Medical School.

 

 

Course Code: CLIN 21200
Section: 17S1
Location: Gleacher Center
Dates:
May 31 to Jun 02
Tuition: $1,300.00
Days/Times: Wed
9:00 AM–4:30 PM
Thu
9:00 AM–4:30 PM
Fri
9:00 AM–4:30 PM

Unlimited slots available

Online Registration Close Date:
May 21, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Fundamentals of Site Management
06/26/2017 to 07/29/2017

CLIN 17400 | Fundamentals of Site Management

This course covers the process of coordinating and managing a clinical study from the perspective of the study site. Students will learn the essentials of coordinating and managing the day-to-day operations of a clinical research study, from planning site logistics and constructing timelines for the study initiation visit to closing out a study. The course will focus on the operational, interpersonal, and data-management aspects of the process.

Synchronous sessions will take place on Saturday July 8, 15, 22, 29 from 10am to Noon CST.     

Prerequisite(s):

Good Clinical Practices and The Drug Development Process

Instructor:
Eileen Dickman

Eileen Dickman

Eileen Dickman, PhD, MBA, CCRC,

has been a clinical trials project manager for over 10 years, managing the financial and administrative processes for industry-sponsored, federally-sponsored, and investigator-initiated clinical research trials. Before becoming involved in the clinical side of research, she worked in preclinical development focusing on the molecular etiology of congenital heart abnormalities. She received her Ph.D. in Nutritional Sciences from the University of Wisconsin-Madison.

Course Code: CLIN 17400
Section: 17U7
Location: Online
Dates:
Jun 26 to Jul 29
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
June 20, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Good Clinical Practices
07/24/2017 to 08/26/2017

CLIN 17100 | Good Clinical Practices

This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.

Synchronous Sessions: Aug. 5, 12, 19, 26 from 10:30am-12pm.

Prerequisite(s):
none
Instructor:
Andrew Kucharski

Andrew Kucharski

Andrew Kucharski, PhD,

has over 20 years of cross-functional project management experience in drug development. As a global operations manager, he has been responsible for NDA filings in the US, Europe, and Japan. Dr. Kucharski is experienced in both clinical and medical affairs and has leveraged global teams from first-in-human trials through product launch and life-cycle management. He possesses a strong interest in pharmaco-epidemiology, pharmacovigilance, and safety signal detection. He has assumed leadership roles in developing strong alliance partnerships, designed and implemented global quality oversight programs and has significant experience in FDA mandated risk evaluation and mitigation strategies. Dr. Kucharski is a sought after presenter at scientific meetings, a published author whose work appears in high impact peer review journals, and has been a guest speaker at U.S. FDA. A trained innovation and change management coach, Dr. Kucharski’s personal mission is to foster talent and mentor individual development. He holds a PhD in Epidemiology focusing on serum secosteroid levels as a risk factor for health disparities.

 

Course Code: CLIN 17100
Section: 17U7
Location: Online
Dates:
Jul 24 to Aug 26
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
July 14, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Fundamentals of Clinical Monitoring
08/28/2017 to 09/21/2017

CLIN 17500 | Fundamentals of Clinical Monitoring

This course introduces students to the processes and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization from the site-initiation visit to the closing out of a clinical study.

Synchronous sessions will take place on Thursday from 8 to 9:30pm on Sept. 7, 14, 21.

Prerequisite(s):

Good Clinical Practices and The Drug Development Process

Instructor:
Melissa Byrn

Melissa Byrn

Melissa Byrn, MBE

, Director of Research Operations and Conduct for the Office of Clinical Research at the University of Chicago Medicine. Melissa has ten years of experience in research operations and oversight, including financial and administrative management, regulatory compliance, research workforce development, and compliance program enhancement. Melissa brings both industry and an academic research perspective to her work and her areas of expertise include FDA law, ICH Good Clinical Practice, medical device research, biomedical ethics, quality assurance auditing, and research process improvement analysis. Melissa obtained a master’s degree in Medical Ethics and Health Policy from the Perelman School of Medicine at the University of Pennsylvania.

Course Code: CLIN 17500
Section: 17A7
Location: Online
Dates:
Aug 28 to Sep 21
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
August 20, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Introduction to Clinical Research: Protocol Development
09/11/2017 to 10/14/2017

CLIN 17000 | Introduction to Clinical Research: Protocol Development

This course is designed for those interested in starting a career in clinical research.  It provides an overview of clinical research from concept to close-out and covers the foundation of how to develop a sound and effective protocol with participant’s safety and regulatory compliance in-mind.  Students will have an opportunity to discuss the various elements of protocol development, including testing study feasibility, design, population, procedures, ethics, investigator(s) and staffs’ knowledge and expertise, and site resources and facilities.

Synchronous sessions will take place on Saturday Sept. 23, 30, Oct. 7, 14 from 10 to 11:30am.

Prerequisite(s):
none
Instructor:
TetKin Yeo
Course Code: CLIN 17000
Section: 17A7
Location: Online
Dates:
Sep 11 to Oct 14
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
September 1, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Statistical Concepts for Clinical Research
09/13/2017 to 09/15/2017

CLIN 11300 | Statistical Concepts for Clinical Research

This course introduces basic statistical concepts, such as hypothesis testing, the meaning of P value, and power determination. Other concepts covered that have particular relevance to clinical research design and monitoring are the importance of randomization and randomization procedures, stratification, crossover designs, nonrandomized concurrent control studies, and the use of historical controls will also be introduced.

 

Prerequisite(s):

Good Clinical Practices, Fundamentals of Site Management, and Fundamentals of Clinical Monitoring

Instructor:
Martin King

Martin King

Martin King, PhD,

is director of statistics at AbbVie and has over 15 years of experience in pharmaceutical research and development, primarily for treatments of HIV infection and Hepatitis C virus infection. He earned his PhD in Statistics at the University of North Carolina at Chapel Hill.

Course Code: CLIN 11300
Section: 17A1
Location: Gleacher Center
Dates:
Sep 13 to Sep 15
Tuition: $1,300.00
Days/Times: Wed
8:30 AM–4:30 PM
Thu
8:30 AM–4:30 PM
Fri
8:30 AM–4:30 PM

Unlimited slots available

Online Registration Close Date:
September 4, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management The Drug Development Process
10/9/2017 to 11/11/2017

CLIN 17200 | The Drug Development Process

This course provides an overview of the drug development and clinical trials processes. Topics include the discovery of new molecules, how discoveries become drugs or devices, the purpose of clinical and pharmaceutical research and development, the economics of drug development, cost/benefit analyses in clinical development, Phase I–IV clinical trials, and an introduction to the unique issues in each phase.

Synchronous sessions will take place on Saturday Oct: 21, 28 and Nov: 4, 11 from 10:30am-12pm CST.

Prerequisite(s):
none
Instructor:
Melissa Byrn, Andrew Kucharski

Melissa Byrn

Melissa Byrn, MBE

, Director of Research Operations and Conduct for the Office of Clinical Research at the University of Chicago Medicine. Melissa has ten years of experience in research operations and oversight, including financial and administrative management, regulatory compliance, research workforce development, and compliance program enhancement. Melissa brings both industry and an academic research perspective to her work and her areas of expertise include FDA law, ICH Good Clinical Practice, medical device research, biomedical ethics, quality assurance auditing, and research process improvement analysis. Melissa obtained a master’s degree in Medical Ethics and Health Policy from the Perelman School of Medicine at the University of Pennsylvania.

,

Andrew Kucharski

Andrew Kucharski, PhD,

has over 20 years of cross-functional project management experience in drug development. As a global operations manager, he has been responsible for NDA filings in the US, Europe, and Japan. Dr. Kucharski is experienced in both clinical and medical affairs and has leveraged global teams from first-in-human trials through product launch and life-cycle management. He possesses a strong interest in pharmaco-epidemiology, pharmacovigilance, and safety signal detection. He has assumed leadership roles in developing strong alliance partnerships, designed and implemented global quality oversight programs and has significant experience in FDA mandated risk evaluation and mitigation strategies. Dr. Kucharski is a sought after presenter at scientific meetings, a published author whose work appears in high impact peer review journals, and has been a guest speaker at U.S. FDA. A trained innovation and change management coach, Dr. Kucharski’s personal mission is to foster talent and mentor individual development. He holds a PhD in Epidemiology focusing on serum secosteroid levels as a risk factor for health disparities.

 

Course Code: CLIN 17200
Section: 17A7
Location: Online
Dates:
Oct 09 to Nov 11
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
October 1, 2017
Online registration closes at 11:59 PM the day before the posted close date.

CLIN 17200 | The Drug Development Process

This course provides an overview of the drug development and clinical trials processes. Topics include the discovery of new molecules, how discoveries become drugs or devices, the purpose of clinical and pharmaceutical research and development, the economics of drug development, cost/benefit analyses in clinical development, Phase I–IV clinical trials, and an introduction to the unique issues in each phase.

Synchronous sessions will take place on Saturday Oct: 21, 28 and Nov: 4, 11 from 10:30am-12pm CST.

Prerequisite(s):
none
Instructor:
Melissa Byrn, Andrew Kucharski

Melissa Byrn

Melissa Byrn, MBE

, Director of Research Operations and Conduct for the Office of Clinical Research at the University of Chicago Medicine. Melissa has ten years of experience in research operations and oversight, including financial and administrative management, regulatory compliance, research workforce development, and compliance program enhancement. Melissa brings both industry and an academic research perspective to her work and her areas of expertise include FDA law, ICH Good Clinical Practice, medical device research, biomedical ethics, quality assurance auditing, and research process improvement analysis. Melissa obtained a master’s degree in Medical Ethics and Health Policy from the Perelman School of Medicine at the University of Pennsylvania.

,

Andrew Kucharski

Andrew Kucharski, PhD,

has over 20 years of cross-functional project management experience in drug development. As a global operations manager, he has been responsible for NDA filings in the US, Europe, and Japan. Dr. Kucharski is experienced in both clinical and medical affairs and has leveraged global teams from first-in-human trials through product launch and life-cycle management. He possesses a strong interest in pharmaco-epidemiology, pharmacovigilance, and safety signal detection. He has assumed leadership roles in developing strong alliance partnerships, designed and implemented global quality oversight programs and has significant experience in FDA mandated risk evaluation and mitigation strategies. Dr. Kucharski is a sought after presenter at scientific meetings, a published author whose work appears in high impact peer review journals, and has been a guest speaker at U.S. FDA. A trained innovation and change management coach, Dr. Kucharski’s personal mission is to foster talent and mentor individual development. He holds a PhD in Epidemiology focusing on serum secosteroid levels as a risk factor for health disparities.

 

Course Code: CLIN 17200
Section: 17A7
Location: Online
Dates:
Oct 09 to Nov 11
Tuition: $1,300.00
Days/Times:



Unlimited slots available

Online Registration Close Date:
October 1, 2017
Online registration closes at 11:59 PM the day before the posted close date.

Clinical Trials Management Good Clinical Practices
11/2/2017 to 11/4/2017

CLIN 11100 | Good Clinical Practices

This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.

 

Prerequisite(s):
none
Instructor:
Lauren Wall

Lauren Wall

Lauren Wall, MS,

has over 10 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. Lauren currently oversees the clinical research operations in the section of Hematology Oncology at the University of Chicago. Her primary responsibilities include planning, organizing, directing, and overseeing daily clinical research operations for over 300+ clinical trials. Prior to taking her role in the academic setting, Lauren worked at an Oncology CRO where she gained experience in clinical trial monitoring and project management. In addition, Lauren traveled to several NCI designated cancer centers to conduct site visit audits. Lauren holds an MSc degree in Clinical Research Administration from the George Washington University. Lauren has a strong passion for teaching and mentoring others about the exciting career opportunities in the field of clinical research.

Course Code: CLIN 11100
Section: 17A1
Location: Gleacher Center
Dates:
Nov 02 to Nov 04
Tuition: $1,300.00
Days/Times: Thu
8:30 AM–4:30 PM
Fri
8:30 AM–4:30 PM
Sat
8:30 AM–4:30 PM

Unlimited slots available

Online Registration Close Date:
October 27, 2017
Online registration closes at 11:59 PM the day before the posted close date.

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