Consider: Reclassification of the CRC Role

The Research Coordinator Unplugged: What Should Be on Their “Stop-Doing” List

Clinical Research Coordinators (CRCs) are an essential component of a clinical research enterprise, serving a critical role in human subject protection through the numerous activities and responsibilities assigned to them. Over the last 15 to 20 years the role of the CRC has expanded well beyond the original concept of clinical management of the subject. Today, the role of CRC has become more sophisticated and includes expectations of expertise in compliance, search administration, grantsmanship, marketing, fiscal and legal activities (Figure 1).

The continual layering of additional responsibilities onto the role of the CRC undermines the primary purpose of the CRC and potentially places the subject, study, PI and institution at risk. As such, the role of the CRC needs to be streamlined and reclassified. We discuss here the transformation of the CRC role, the implications of this and suggestions on how to restructure clinical research infrastructure within an institution to improve efficiency and research excellence and compliance. We also present data here from two national surveys distributed to identify training and support provided to CRCs and overall CRC job satisfaction.

To support the professional development of Clinical Research Coordinators (CRCs) and help guide institutions how to organize and network their CRC workforce.

• Adherence to an IRB approved protocol • Participation in the proper consenting of study subjects • Support of the safety of clinical research subjects • Coordination of clinical treatment, study visits, and follow-up care • Subject screening, recruitment, and enrollment • Maintenance of study source documents • Proper reporting of adverse events

• Submissions to regulatory authorities (e.g. IRB, FDA, etc.) • Regulatory documentation development and management • Completion of case report forms (paper & electronic data capture) • Coordination of pre study, initiation visit, monitoring visits • Collection, processing ,shipping of laboratory specimens • Maintenance of drug accountability documentation • Study budget preparation • Management of study finances including resolving study subject billing issues • Acting as liaison for research subject, investigator, IRB, sponsor, healthcare professionals

The Research Coordinator “Unplugged” What CRC tasks should we unplug?

• Which of your current tasks would you not agree to if you were making a decision about it today?" Those identified are tasks to unplug. • Create a “stop doing” list to complement your “to do” list.

The CRC Challenge • Without adding new resources, how do we redesign the structure of clinical research to enhance efficiency? • 1 person/role cannot do it all. • The CRC role has expanded to the point of explosion. • Is it realistic to expect one position to be responsible for so many facets of clinical research? • Create new positions to take on excess roles being delegated to the traditional CRC.

Survey Results

• The CRC role has become increasingly complex, expanding well beyond the traditional clinical management of the subject.

• Academic Health Centers (AHC) are encouraged to reclassify the CRC role and to create additional positions within a clinical research infrastructure to alleviate the CRC from tasks that will detract from their ability to carry out their core responsibilities following Good Clinical Practice and to ensure human subjects protection.

• Potential additional clinical research titles/roles are proposed. The RCT recommends that institutions work with their Human Resources Department to create standardized job description and develop a career ladder for the CRC pool in an effort to retain talent.

Conclusions