Research Staffing Core

Overview of Services

The Research Staffing Office Core (RSO-CORE) Provides Clinical Research Personnel to Support All Types of Clinical Research Studies, and excels at matching top quality clinical research staff with clinical investigators and teams.

The RSO is comprised of clinical research professionals with diverse backgrounds and various levels of education and experience, including registered nurses, respiratory therapists, coordinators who hold advanced degrees in psychology, public health, business, education and clinical research. Our coordinators and clinical project managers are experienced with many types of clinical research studies, including behavioral health, tissue collection, data abstraction, interview/survey based, and all phases of drug and device trials.

Study Coordinators
RSO study coordinators are available on a fee-for-service basis to assist investigators at all stages in the implementation and conduct of their clinical research studies. Study coordinators are available full and part time to support investigators with the following aspects of clinical research:

IRB submission process

• Preparation of regulatory documents
• Subject recruitment
• Informed consent process
• Subject registration in EPIC
• Coordination of study activities
• Completion of case report forms
• Tracking and reporting of serious and non-serious adverse events
• Drug accountability
• Sample collection and processing
• Many other areas of study-related support

Clinical Project Managers
The RSO can provide Clinical Project Managers to oversee and support clinical research studies being conducted at multiple institutions, where CHOP is either the sponsor of the study, the coordinating center or the main trial site. RSO Clinical Project Managers (CPMs) provide leadership and are directly responsible for the implementation of study activities and site management for the multi-center clinical study protocol. CPMs are responsible for supervision, training, support, and management of staff (direct and indirect) to ensure compliance with study protocol and all FDA/NIH regulatory policies.

Study Feasibility
The RSO collaborates with Investigators and sponsors to determine study feasibility. The staff reviews study protocols with Investigators to identify clinical, logistical and financial issues that may occur during the study. Study coordinators participate with Investigators and industry sponsors in pre-study site visits to evaluate the operational and enrollment feasibility.

Study Start Up Activities
RSO assists investigators who are approached to participate in a clinical research study by industry or other academic centers with their study start up activities. We help facilitate the budget and contract negotiation process, obtaining required regulatory documents, hosting site qualification and site initiation visits, attending investigator meetings, and regulatory approvals.

IRB Submissions
The RSO staff assists investigators in the preparation of study documents for submission to the IRB. Services include:

• Initial Submission
• Informed Consent Documents
• Continuing reviews
• Study Completion request
• External/Internal Serious Adverse Events/ Safety Reports
• Protocol Modifications/Amendments
• Protocol Deviations
• Recruitment Materials/Advertising
• Protocol Development

The RSO will assist an investigator with the development of a protocol that includes all aspects necessary for CHOP's standard template.

Leadership

Michele Toms | Administractive Director
toms@email.chop.edu
215-590-7727

Kareem Green | Business Operations Manager
greenk5@email.chop.edu
267-426-0652

Location and hours of operation

Links and Resources

1. Children’s Hospital of Philadelphia Research Institute Website
2. CHOP Research Institute Intranet

Contacts