Topic - "Setting the Stage"
Please write a paper answering the following questions:
1.
What are some of the things a project manager needs to be
thinking about when starting up or implementing a clinic research study?
What would you prioritize?
2. What are some of the possible roadblocks or issues that you
might face? How would you approach them?
PowerPoint Presentation Module 1 Getting Oriented to Clinical Research Project Management CRM 761 Beth Loots, MPH MSW Course Overview Description, aims, objectives Course description This course will provide professionals with expertise in project management, as project-based work continues to proliferate both in scale and complexity, with organizations and clients demanding greater efficiency, outcomes, and proficiency. This curricula is designed to take participants through the entire life-cycle of a project. 3 Course level outcomes Upon completion of this course, the student will be able to: Define a clinical trial using standard project management processes and technologies, Integrate core project management principles and processes for effective clinical research management. Evaluate how elements of cultural competency, project management and meeting management improve the performance of culturally diverse, multi-disciplinary teams. Select among various team building approaches to build an effective team. Assess organizational, cultural and personnel factors that influence successful clinical research performance. 4 Approaching the course aims Use academic evidence and real life examples and discussion Touch on key points such as project management principles, organizational factors, project planning processes and tools, cross cultural work, and interdisciplinary teams 5 Key outcomes I have in mind Developing or expanding your knowledge and skills around what it might take to successfully plan and implement clinical research studies Learning to skillfully lead and manage people and teams is key, so we will spend quite a bit of time on that I will share ideas and experiences with the process of managing studies and some tools you can use for that 6 PM skills 30% research knowledge and technical skills 70% communication skills Richardson B. & Newman RW. Clinical trial management - an integrated process. Drug development; 2006. A few words about lingo Different terms seem to be used throughout the literature: Clinical Research Project Manager, Clinical Trial Manager, Project manager, Research Manager, Clinical Research Coordinator*, etc. *Project managers may manage Clinical Research Coordinators (CRC) (which also go by many names), and/or they themselves may be a CRC or fulfill some of the coordination roles of a CRC. In my mind a CRC is more focused on implementation of the study, whereas a PM is focused on leading the overall project planning and implementation. That is not to say that a PM does not get involved in the day to day running of the study – they can and should do that to some extent. 8 A few words about lingo I've decided to generally use the term "Project Management" or "Clinical Research Project Management" in this course The important part is not so much the title as is the function of this person on the team which is to help the PI lead the study to success Course roles and responsibilities – me I aim to operate from a strengths-based model, meaning I value the skills, experiences, and perspectives that each person brings to the table By the way this is also how I do project management – often asking team members questions to get input and move processes forward in a more informed way I will aim to work in collaboration with you to support your learning goals 10 Course roles and responsibilities – you I hope that you will find the course interesting and I trust that you will be engaged Please give me feedback and ask questions as we go. My goal is to continuously learn and improve based on your important input. PDCA (Plan Do Check Act) I am available for questions and concerns so please contact me when needed Course textbook and readings Martien, N. & Nelligan, J. 2018. The Sourcebook for Clinical Research. Elsevier, Inc.: United Kingdom. This book is aimed at providing a roadmap to research teams navigating clinical trials and clinic research more generally There is an accompanying online resource of templates, forms, and checklists available I've chosen a few other readings to supplement the text and the slides Assignments Power point from me every week There will be a course-long research paper, which I have separated into chunks each week The discussion board will also be due every week I have provided additional videos and extra readings alongside text book readings each week Lay of the Land Some of the realities faced day to day What usually happens when you start You might start a single study right at the beginning as the PM...more likely, you will join an existing team which has a number of studies at various stages. "The life of a researcher is...managing and implementing a portfolio of different projects on an ongoing basis." You will likely be navigating different projects that are in different stages at the same time such as scientific development with investigators and other collaborators, operational setup, logistics of running various trials, database management, people management, and others Often underfunded and understaffed Often you will be stretched in multiple different directions at same time Lund Pedersen, C. 23 January 202. This simple tool can help you manage multiple research projects: how to master the art of prioritization. Nature Index. https://www.natureindex.com/news-blog/simple-tool-can-help-manage-multiple-research-science-projects 15 Key things to think about re: your role Your job as the PM will be to quickly get on board; assess the division, investigator, and studies' priorities and timelines; and move many projects forward on multiple fronts simultaneously Very important to know how to manage people and teams Need to know how to navigate the specific institution in which you work You are the hub for assessing resources and priorities, and moving projects forward Some parameters around what you need to be skilled at You may be expected to be a content expert in research processes, particularly IRB, regulatory, and working with sponsors, since PIs tend to rely on PMs for this aspect of the work Skills that you probably already have such as planning, prioritizing, multitasking, and communication are vital to a project manager's success. You can work to continuously improve these skills. PMs don't tend to be the experts on the science – that is usually the role of the PI. That said, the PM should be somewhat familiar with the content area and with the patient/family focus of clinical research You will also be expected to manage the activities of people on your team. This is not a small feat. People management takes time, attention, and skills 17 Realities Gets complex fast Things almost never go as planned Usually hidden (and sometimes competing) agendas that you only discover once you start doing the work. You need to interact with others whom have different timelines and priorities than yours for things like grants and contracts, institutional approvals, IRB approvals, other committee reviews, IND applications, supplies, etc. Your primary objectives – successful planning, startup, execution, and closeout of clinical studies – may not match the objectives of others with whom you need to collaborate 18 Keeping the ship from veering off course Your clinical investigator themselves will have multiple other competing priorities, and varying levels of skills managing people and projects Often your project veers off course in terms of time or resources There are many things that you will learn along the way such as not knowing exactly whom to contact for what, what hoops need to be jumped through, and what pieces are missing that you later discover Continuously navigate towards the goals and objectives you are aiming to accomplish 19 Real life examples I've been in a few positions where I jumped into fires right from the start Things like – deadlines already missed for IRB renewals, personnel and team problems that hadn't been dealt with, lack of resources (no pens, desks, chairs, or computers!), absence of standard procedures, no project plan, people working at cross purposes or duplicating work, terrible communication, key priorities not addressed, etc. That's often how it is...your role as PM is often to establish structure where it's lacking 20 Jumping in Hopefully this course will provide you with some tools and some ways to think about how to establish this structure and lead projects to success Even with the best laid plans, clinical research throws curve balls A LOT And...that's kind of what makes it interesting, if you can learn how to navigate it. Part of the PM role is learning to identify what really is a fire and what is just being treated like one. Defining your own and your team's priorities within the larger context of what you are hoping to accomplish is key. Your "why" I would encourage you to reflect on why you are interested in being part of clinical research Sometimes people have personal or family experiences with medical care or clinical research that drive them towards this field Many appreciate the scientific and medical advancements that can be supported through great project management It can be a great fit for people who enjoy both the organizational/project/logical part of it and the sometimes more nebulous team/people part There can be a good career opportunity because there aren't a lot of people with specific skills in clinical research project management. Often you see people who have either clinical research experience or project management experience but not both.