Project Management Services for Researchers

Advanced Support for Leading-Edge Research Projects

The Clinical Research Center (CRC) has a dedicated staff of experienced research coordinators and research nurses to assist in implementing and managing clinical research projects. The CRC Project Managers are available to assist investigators and their research teams in all phases of clinical research, providing services that include assisting with the organization, implementation and completion of clinical research studies.

Services offered by the Project Management Team include:

Study Start Up

Our team supports every aspect of study start-up, ensuring a strong foundation for successful research:

• Assistance with IRB submissions
• Study budgeting
• Regulatory binder creation and organization
• Development of data collection forms/source documents
• Collaboration with Research Pharmacy to implement study drug administration plan
• Create implementation plan with study team and other departments/divisions at BIDMC
• Sponsor site visits

Project Implementation

We provide comprehensive support throughout project implementation:

• Research participant recruitment and screening
• Study coordination and research visit facilitation
• Assistance with determining eligibility
• Clinical assessment of participants for adverse events, concomitant diagnoses and medications
• Scheduling and carrying out of research procedures
• Development of relationships to foster participant retention
• Data collection, data entry, and data cleaning
• Assistance monitoring visits, etc.

Study Close Out Activities

We manage study close-out activities to ensure smooth transition to completion:

• Final data entry and data cleaning for database close
• Final monitoring visit and sponsor close out activities
• IRB close out
• Close out with Clinical Trials Office