Clinical Research Skills: Beginner

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: Essential Documents: What are they? What do they mean? How should they be filed?

Daniel Jones, Senior QA/QI Specialist, Human Research Quality Improvement Program “If it wasn’t documented it didn’t happen!” In this session, we will review the list of essential documents and GCP requirements for documentation. For each document, we will describe the …

MGH Division of Clinical Research

Clinical Research Skills: I'm New - What Should I Know?

Stacey Grabert, Assistant Director DCR Center for Clinical Research Education In this session, the DCR will welcome new study staff to MGH and introduce the clinical research skills program. We will review the new hire manual, mandatory training, relevant websites, …

MGH Division of Clinical Research

Clinical Research Skills: Making Connections: Essential patient outreach skills

Nicole DiOrio, Clinical Research Coordinator, Reproductive Endocrine Unit This is a crash course on building patient outreach skills. Topics will include outreach initiatives, managing follow-up communications, and diffusing challenging patient interactions. Participants will learn strategies to initiate contact with potential …

MGH Division of Clinical Research

Clinical Research Skills: Reading a Clinical Research Protocol: Where to begin

Allie Sosinsky, Program Coordinator, Psychiatry One of the very first things a new clinical research coordinator is asked to do is read a study protocol. Depending on the complexity and number of protocols along with a limited amount of time …

MGH Division of Clinical Research

Learn Something New! Effectively Communicating with the Study Team

Tara Bresnahan, Clinical Research Nurse Manager, Division of Vascular & Endovascular Surgery Communication is instrumental in the implementation of clinical trials. Effective team communication can save time and help ensure compliance with GCP Guidelines, protocol adherence, and patient safety. This …

MGH Division of Clinical Research

Learn Something New! Informed Consent: The speed dating of clinical research

Speaker: Caitlin Stafford, Clinical Studies Specialist, General Surgery/Section Colon and Rectal Surgery In this session, we will briefly review regulations and polices involved in the informed consent process. The goal of this session is to teach new study coordinators how …