Project Management Services
About Our Project Management Services
The Clinical Research Center 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
- 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
- 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
- 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