Clinical Research Skills: Advanced

Clinical research is complicated. It is governed by regulations, guidelines and institutional polices. Study start-up, conduct and close-out involve so many different tasks – IRB submissions, recruiting, enrolling, financial management, data collection, analysis – just to name a few. Clinical research can be overwhelming even for experienced study staff.

The goal of the clinical research skills program is to help study staff learn about different aspects of clinical research from peers through practical application of a skill while maintaining compliance with Good Clinical Practice and institutional policies.

All clinical research study staff can attend. Participants must have completed CITI Training in Human Subjects Research and Clinical Research Conduct: Research Staff Training at MGH prior to enrolling in the skills program. It is preferred but not mandatory to have completed Good Clinical Practice in an Academic Research Institution prior to enrolling in the skills program.

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MGH Division of Clinical Research

Clinical Research Skills: Managing PI Initiated Studies

Katherine Brock, Administrative Manager, Division of Nephrology Principal Investigator (PI) initiated studies offer scientists the freedom to perform the research that they are most passionate about however that investigative freedom also increases the responsibilities of the study team. Unlike industry …

MGH Division of Clinical Research

Learn Something New! How to write study-related standard operating procedures (SOPs)

Speaker: Mallory Hillard, MSN, RN , Diabetes Research Center Standard operating procedures (SOPs) are a set of step-by-step instructions created to help study teams perform study-related tasks accurately and uniformly. In this session, we will discuss common SOPs for research …

MGH Division of Clinical Research

Learn Something New! Managing Multiple Studies: What's the Plan?

Ashley Seiger, Program Manager, Center for Genomic Medicine In this session we will review the challenges of managing multiple studies at once and provide tools for being successful and compliant. This session will go over some strategies for prioritizing, delegating, …

MGH Division of Clinical Research

Learn Something New! Personalizing recruitment programs: Enhancing the patient-researcher experience

Nicole DiOrio, Clinical Research Coordinator, Reproductive Endocrine Unit This session is designed for clinical research teams interested in rebuilding or revising their recruitment initiatives. This course emphasizes the “back to the bedside” philosophy and how it can be leveraged to …

MGH Division of Clinical Research

Learn Something New! Training A New Hire: What should happen during the first two weeks of employment

Camille Staco-Targete, Operations Manager, Diabetes Research Center Participants will be provided resources and materials to help them create a 2 week training schedule for new hires and implement the employee’s training. They will have the opportunity to practice creating a …

MGH Division of Clinical Research

Learn Something New! Where to Start During Study Start-up?

Grace Ha, Project Manager, Cardiovascular Research Center This session will provide an overview of what is required to start up a study, when it should be done, issues you may encounter during implementation and how those should be overcome. Audience: …