- Active clinical trials: 52
- Study coordinators within
the CRSO: 26
- Coordinators certified by the Association of Clinical Research Professionals: 11
The Clinical Research Support Office (CRSO) is the central office for clinical research support services at CHOP; it was established in 1999. The CRSO provides leadership, administrative guidance, and support services to support both novice and experienced clinical investigators with investigator-initiated and industry-sponsored research projects.
The mission of the CRSO is to make it easier for the CHOP research community to conduct quality clinical research projects. The CRSO’s services include:
- Clinical research personnel (study coordinators, research nurses, program/project managers, clinical research supervisors) provide support to clinical investigators, enabling investigators to carry out all types of clinical research projects in a manner consistent with CHOP’s mission—excellent patient care, top-quality education, and innovative research. The CRSO assists with the start-up, execution, and completion of clinical research projects and ensures compliance with local and federal requirements. CRSO personnel are well-trained clinical research professionals who can be assigned to support any type of clinical research project.
- Regulatory affairs professionals provide regulatory guidance, operational support, and institutional oversight for clinical trials conducted under a CHOP sponsor-investigator IND/IDE. The CRSO also coordinates and submits regulatory correspondence to regulatory committees and agencies such as the IRB, FDA, and DSMBs.
- Contract administrators negotiate Clinical Trial Agreements (CTA) for industry-sponsored clinical research.
- Recruitment Enhancement Core (REC) collaborates with research teams to strategize, develop, and implement marketing and recruitment plans to increase enrollment into clinical research projects. The REC liaises with other clinical and research departments to leverage institutional biobanking and data repository resources with the goal of building a robust and efficient sample and data biorepository.
- Research navigation services guide and connect research personnel to answers, resources, and tools to facilitate clinical research. The navigator is available to assist investigators with any questions that arise during the design, start up, and execution of clinical research projects.
- Clinical research professionals will assist the research community with the development of clinical research budgets, operational review of investigator-initiated protocols, and other administrative-related activities.
The CRSO staff works in partnership with investigators to ensure the protection of human subjects in accordance with Good Clinical Practice, federal, state and/or local regulations and the requirements of the study sponsor.