Research Staffing Core Services

Research Assistants and Study Coordinators support clinical research studies conducted at CHOP. Full study coordination activities include:

• Study start-up (IRB, CHPS, eSifter, Oncore, Complion electronic regulatory binder set-up)
• Hosting site qualification and site initiation visits
• Facilitating of monitor visits and site audits
• Preparation and ongoing support of regulatory documents
• Developing written consent forms and e-consents in REDCap
• Subject recruiting/consenting
• Data entry and management
• Study visit scheduling and coordination
• Tracking and reporting serious and non-serious adverse events
• Study close-out
• Assisting with grant and manuscript writing
• Budget preparation and management
• Facilitating execution of collaborative agreements with external institutions
• Multi-site study management and oversight

Study Leads and Program Managers oversee and support clinical research studies conducted at CHOP. Their areas of expertise include project, staff, and budget management in addition to the full study coordination activities listed above.

Clinical Research Nurse Coordinators provide supplemental clinical expertise to support PIs for the study's duration. In addition to study coordination activities, their tasks may include administration of study medications, education on study medication and procedures, pending orders, adverse event/serious adverse event review (follow-up and management), and facilitating standard of care needs of clinical trial participants.

Clinical Research Respiratory Therapist Coordinators provide specialized expertise in respiratory and pulmonary research-related clinical research activities, including pulmonary function testing, multiple breath washouts, forced oscillometry, and spirometry. In addition, they perform all study coordination activities.

Team Managers conduct all aspects of the interviewing, hiring, and onboarding processes, including orientation and training of new staff. They support staff in executing clinical research projects, managing team dynamics, and navigating complex study processes and CHOP systems.

In addition, they provide administrative support through Kronos approvals, goal planning, yearly evaluations, and human resource communications. Management and oversight of RSC staff allow PIs to focus more on their research projects and less on administrative responsibilities.