Project Management Support Service
Project Managers
Project Managers (PMs) from the Department of Clinical Research (DCR) at Massachusetts General Hospital provide administrative support including budget creation and management for new clinical research studies, study start-up support, monthly research fund review, study conduct and regulatory assistance, and oversight of study close out.
In addition, project managers work with investigators to respond to sponsor and internal audits, develop and implement corrective action plans and standard operating procedures (SOPs).
Fee Structure
The first six hours of service are free of charge. Thereafter, the scope of services is negotiated with the investigator based on a rate of $50/hour.
Institutional Review Board (IRB) Support
The Department of Clinical Research (DCR) also provides Institutional Review Board (IRB) submission and regulatory support to clinical investigators. Our clinical research coordinators can prepare IRB applications, work with investigators to respond to the IRB’s queries, and edit consent forms and other documents to support full and continued IRB approval of the study.
Fee Structure
Full IRB Board Review: $3,500 plus applicable overhead. An IRB expedited review, continuing review applications and other regulatory submissions are negotiated based on a rate of $50/hr.
Faculty
Francine J. Molay, MS
Consultations
Project Management
Project Managers (PMs) from the DCR can provide administrative support including budget creation and management for new clinical research studies, study start-up support, monthly research fund review, study conduct and regulatory assistance, and oversight of study close out.
Regulatory Guidance (IND, NDA, SOPs)
Project Managers from the DCR can provide regulatory support to clinical investigators, including preparation of IRB applications, working with investigators to respond to the IRB’s queries, and editing consent forms and other documents to support full and continued IRB approval of the study.