Conducting clinical research requires the support of a team of individuals with specialized experience. Within the NINDS Clinical Trials Unit (CTU), two offices provide Research Staffing Support.
The Research Staffing Support Office (RSSO) provides centralized research staffing support in 3 main categories: Protocol Navigation (PN), Patient Care Coordination (PCC), and clinical research staff hiring support for PNs, PCCs, and Research Coordinators (RCs) primarily through the SOAR contract mechanism.
The Research Coordinator Office (RCO) provides centralized research staffing support for Research Coordinators (RN and non-RN), as well as hiring support for these positions.
Protocol Navigation: PNs provide PI support in the writing of clinical research protocols, consents and other supporting documents, regulatory submissions and approvals of those documents, as well as maintenance of the site regulatory binder for PIs as assigned. PNs serve as regulatory experts to advise PIs and study teams on current applicable regulations that govern their protocols.
Patient Care Coordination: PCCs provide PI support in the services required to coordinate research participant visits. This includes managing all aspects of participant scheduling, such as new participant visits, tracking participant visit windows to ensure visits are scheduled per protocol, travel, lodging, clinic visits, procedure appointments, participant communications, and generally liaising between the study team and the research participants to ensure study appointments run smoothly.
Research Coordination: RCs (Including RNs serving as RCs) provide guidance and management services for research studies involving human subjects. RCs have a wide variety of research responsibilities, highlights of which are listed here:
- Provide PI feedback in protocol development discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, and data quality.
- Assist Investigators in community outreach, recruitment, and screening of research participants.
- Coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates, and practices.
- Integral in the creation and maintenance of MOPs, Source Document Forms, and Case Report Forms.
- Assist researchers with study testing and other duties associated with the completion of study visits and ensure protocol and human subject safety regulation compliance.
- Document and/or ensure documentation of research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired data points.
Protocol Navigator Positions: email@example.com
Research Coordinator Positions: firstname.lastname@example.org.
Patient Care Coordinator Positions: email@example.com
Clinical Research Staff Hiring Support:
Identifying and selecting qualified candidates for clinical research support staff can be daunting and can have a significant effect on clinical protocol execution. The CTU can assist study teams with the screening and interviewing of potential candidates for clinical research staff support positions, i.e., Protocol Navigator, Research Coordinator, and Patient Care Coordinator positions within the NINDS Division of Intramural Research.