Kathleen O’Malley, RN, BSN, CCRP

Director of Education and Training, Jefferson Clinical Research Institute; Assistant Program Director, master’s in clinical research, Jefferson College of Life Sciences

Clinical Research Careers: Hidden Gems
Clinical Research is a growing industry with vast career opportunities, but the supply of clinical research personnel is not keeping up with the demand! In this presentation Ms. O’Malley will describe the wide variety of roles involved at clinical research sites, emphasizing the skills required and many of the less well-known and understood career opportunities. The presentation will describe how human subject research fits into the larger drug approval process and pharmaceutical industry. By the end of this presentation attendees will be able to describe the critical need for research personnel, the growth of the industry, career opportunities, the necessity for diversity and ways to overcome barriers to entry.

Dr. Martin Edelman

Deputy Director for Clinical Research and Chair, Department of Hematology/Oncology; Deputy Cancer Center Director for Clinical Research, Fox Chase Cancer Center

Clinical trial process for cancer.
Medical oncology is unique amongst medical specialties in that clinical trials are considered the “standard of care” for most cancers.  This is a consequence of the very limited treatments that were available at the time the specialty began in the middle of the 20th century and general skepticism as to whether drugs should be used to treat cancer.  In this talk, I will describe the clinical trial process for cancer, as well as describe my own professional journey as a medical oncologist and clinical trialist.

Jennifer Sheller, MPH, ACRP-CP

Associate Vice President, Merck Global Clinical Trial Operations

Merck - Clinical Trial Operations & Careers
In this session, you will learn about the overall process for which drug and vaccines are developed, including more detailed focus on how clinical trials are conducted. You will also learn about Merck and Global Clinical Trial Operations (GCTO) organization’s important role in drug & vaccine development, along with the various groups and roles within GCTO (including in local offices in Philadelphia, North Wales, PA and Rahway, NJ). You will also learn about our partnership and resources via the Association of Clinical Research Professionals to help begin a career in clinical research. After the conference, you will have an opportunity to meet several of our team members to learn more directly and ask questions.

Laura Fluharty, MPH

MPH Executive Director, Clinical Research Operations and PSOM Clinical Research Privacy Officer, University of Pennsylvania Health System

The Importance of Clinical Trials in Medicine
The goal of this presentation is to give an overview of clinical trials and the importance of clinical trials in the development of diagnostics, devices, clinical care, and therapeutics. The different types of clinical trials will be defined, the purpose of each of the four phases of clinical trials, and the associated costs with drug development. To gain perspective, a history of clinical trials will be presented from ancient medicine to randomized trials, as well as the implementation of important protections for participants. Finally, I will discuss important reasons for choosing a career in clinical research, why clinical research is a hot career choice, and opportunities offered at Temple University.

Robert C. Sterling, Ph.D.

Director Clinical Research Programs, Co-Director, ICO Division, Graduate School of Biomedical Sciences and Professional Studies, Professor of Pharmacology and Physiology, Drexel University College of Medicine.

A Primer on Research Generalizability or Just How Useful Are My Results Anyway?
The purpose of today’s session is to familiarize attendees with the concept of external validity and how it relates to the generalizability/usefulness of clinical research findings. Clinical Research is a branch of healthcare science that is concerned with safety and efficacy issues related to the prevention, diagnosis, and treatment of disease. In practice, clinical researchers conduct applied research that tests the efficacy of medications, devices, diagnostic products, as well as innovative treatment regimens. In considering study design, the clinical trial is frequently viewed as the sine qua-non. However, questions about volunteer bias as well as the environment(s) within which clinical research studies are conducted, can lead to concerns about the generalizability (i.e., external validity) of their findings. While it may be easy then to dismiss the findings of a single study as being non-representative, science ultimately proceeds by replication.

Yvonne Balgenorth

Community College of Philadelphia student and Clinical Trial Coordinator B, Hospital of the University of Pennsylvania, Penn Frontotemporal Degeneration Center.

As a Clinical Trial Coordinator, I have had the opportunity to work directly with Clinical trial participants and to contribute to the advancement of treatment options. Clinical Trial coordinators are important when a drug enters a series of phases to determine its safety and efficacy for humans. Clinical Trial Coordinator make sure the trial is completed up to standard - including organizing study visits, interacting with participants, collecting data, and keeping close communications with their Principal Investigator, Institutional Review Board, and Contract Research Organization or Sponsor.

Laurie Kilpatrick, Ph.D.

Assistant Dean for Clinical Research and Professor, Center for Inflammation and Lung Research, Department of Microbiology, Immunology and Inflammation, Temple University Lewis Katz School of Medicine

The Importance of Clinical Trials in Medicine
The goal of this presentation is to give an overview of clinical trials and the importance of clinical trials in the development of diagnostics, devices, clinical care, and therapeutics. The different types of clinical trials will be defined, the purpose of each of the four phases of clinical trials, and the associated costs with drug development. To gain perspective, a history of clinical trials will be presented from ancient medicine to randomized trials, as well as the implementation of important protections for participants. Finally, I will discuss important reasons for choosing a career in clinical research, why clinical research is a hot career choice, and opportunities offered at Temple University.

Lisa Palladino Kim

Program Director, MS Clinical Research Management Program, Rutgers School of Health Professions

Seize Opportunities Along the Career Path
The speaker will explore how by just making one request, her career started in the pharmaceutical (clinical research) industry. She will highlight how her 15 years of pharmaceutical expertise, with a concentration in Clinical Operations, allowed her to gain experience leading career, policy, and process development initiatives. This experience was applied while she performed the Drug Information Association (DIA) Annual Program Committee Co-Chair role for the Clinical Operations/Patient Engagement Program track, Professional and Student Poster events, and Young Professional programs. This led her to becoming a key contributor of the Regional Asia Clinical Trial Association Forum (REACTA), Association of Clinical Research Professionals (ACRP) Content Committee, and the Multi-Regional Clinical Trial Center of Brigham and Women’s Hospital and Harvard (MRCT) Health Literacy workgroup.  In addition, the presenter will highlight how the 36-credit Rutgers School of Health Professions Master of Science in Clinical Research Management (CRM) Program enhanced her clinical research expertise, expanded her network, balanced her life goals, and shaped her road to professor hood. She will explore how her love and experience with clinical research, training, and process improvement has guided her to be a significant member of the globally accepted JTF Core Competency Framework for the Clinical Research Professional committee as well as co-lead the MRCT Joint Task Force (JTF) Clinical Project Management Competency workgroup. She even expanded her global experience by living in South Korea.