Clinical Research Services

The OCR provides centralized and integrated support services across the entire research enterprise to provide comprehensive, coordinated resources, education, and services to scientists, physicians, research staff, and research volunteers.

Protocol Development & Support

• protocol development from inception to trial
• collaborate directly with investigators on the improvement and refinement of submitted proposals
• document tracking
• informatics
• biostatistics

Study Initiation & Conduct

• centralized resource for industry sponsors
• research nurse coordinators
• central registration of studies and activity

Clinical Research Budget & Billing Support - provides cost effective and sustainable research business models

• budget creation & preparation: contact Sonia Kleiner, (973) 972-9691
• account setup, reimbursement and revenue analysis
• billing verification support for clinical research
• budget & tracking tools and resources to identify research-related vs. routine care services
• policies, guidance and training for faculty and staff
• ongoing training and education

Regulatory Support - regulatory activities required for the successful conduct of translational and clinical research

OCR bridges interrelated areas:

• Support for and Knowledge of Regulatory Requirements - contact CRC Regulatory Coordinator, Baljinder (Bali) Singh, M.A., R.D., C.D.E
  singhba@umdnj.edu
  tel: (973) 972-3811
  fax: (973) 972-4606
  ACC D1715
  mailing address:
  140 Bergen St., ACC Rm D1640
• Data and Safety Monitoring Plan (DSMP) development and implementation
• Research Ethics Training
• Human Research Subject Advocacy
• Strategies and Tools for Sharing Best Practices in Regulatory Support and Advocacy
• Protocol Authoring and Informed Consent Authoring and Translation
• Support in achieving Patient Safety and Regulatory Management and Compliance:
  • Monitoring and Auditing
  • IND Specialist Monitor