Clinical research resource support for off‐site research coordinators in intensive and specialty care units

Abstract Clinical Research Coordinators (CRCs) are vital collaborators in a clinical research project. They often are the primary liaisons between investigators and human participants in studies and are involved in every aspect of many protocols, including participant recruitment, care (both usual medical care and specific study‐related monitoring and procedures), data collection, specimen processing, and follow‐up. The Clinical Translational Science Award program, which was created by the National Institutes of Health in 2006, has significantly expanded the venues in which Clinical Research Resource (CRR) – based CRCs are embedded. CRCs functioning in these areas, outside of the research‐focused in‐patient environment of the CRR, are designated as “off‐site” CRCs. Many of these locations, such as intensive care units and emergency departments, require that CRCs interact regularly with healthcare providers whose primary functions are focused on providing optimal patient care rather than research and often involving very complex patients. These off‐site CRCs require additional training and support outside of the usual research‐oriented environment of the CRR. They are required to function within the context of the patient‐care team while fostering implementation of collaborative research. This is a description of such a program specifically geared to off‐site CRCs with the goal of enhancing the quality of research and experiences of CRCs.


INTRODUCTION
The Clinical Translational and Science Award (CTSA) program was designed to "provide integrated intellectual and physical resources for the conduct of original clinical and translational science." 1 Multiple investigators have recognized the essential role of Clinical Research Coordinators (CRCs) in clinical research in general and in meeting the National Institutes of Health (NIH) CTSA goal described above in particular. 2,3 The aims of the Clinical Research Resource (CRR) within the Clinical Translational Science Award (NIH UL1 TR00040 at Columbia) are to provide outstanding resources and training to facilitate and implement the development, performance, and dissemination of innovative clinical and translational research (see Figure 1). Research utilizing CRR support has expanded beyond the traditional inpatient and outpatient units to include sites throughout the medical institution. CRCs are now conducting research in units where, unlike the CRR, they are not part of the routine personnel and are at most adjunct participants in the care and management of patients. These areas outside of the CRR are designated as "off-site" locations, and often have more complex, debilitated research participants and less support from the phlebotomy, nursing, and other services in the usual CRR inpatient and outpatient units. Over the last two cycles (2011-2016 and 2017-2022), the Columbia CTSA (NIH UL1 TR00040) has maintained an average of 19 "off-site" protocols per year (23 per year if the pandemic years are not included) that are conducted in inpatient units (obstetrics and gynecology units as well as pediatric and adult intensive care units [ICUs] and emergency departments [EDs]) outside the CRR. This is a description of a unique and innovative program to provide a training ground for CRCs without advanced degrees in clinical health care. These "off-site" CRCs are embedded/integrated into ICU and multispecialty care units with the goal of fostering better consolidation of the CRR within the Irving Institute for Clinical and Translational Research (IICTR) at Columbia University. The off-site program is primarily designed to facilitate the integration of CRCs into the increasing breadth of research studies that are based in units which are outside of the usual milieus of the CRR, such as ICU and other specialty care units and to improve retention of CRCs. The program draws on reports of off-site CRC needs 4 to enhance collaboration and facilitate complex studies in other units. This is part of programming to facilitate an organized, continuous, and "de-siloed" collaboration between the clinical and research staff 5,6 within these units at Columbia University Irving Medical Center in service of optimal research quality and minimal burden to participants, clinicians, and investigators to enhance and augment research in traditionally more complex areas. In addition, the program for resource integration and ongoing assessment can potentially be extended to other research venues.

PROGRAM DEVELOPMENT
Obstacle identification and training needs are determined through qualitative interview sessions with the coordinators. The sessions are held weekly with each coordinator and then discussed in a general monthly session attended by all the coordinators and the CRR directors. During these sessions, an overview of ongoing protocols is presented, and the coordinators describe obstacles delaying or preventing implementation. Specific needs and trainings to address identified issues is held during the monthly sessions.
As shown in Figure 2, there are a number of obstacles to fully embedding CRCs into off-site locations. These include lack of a clear definition of necessary CRC skill sets in these expanded venues; lack of formal programming to integrate CRC into the complexities of the special and ICUs and their teams; and lack of CRC training in the more complex administrative and infrastructure requirements in these units. Unfortunately, the CRC field has been left open for interpretation without clear definitions of necessary CRC proficiencies and insufficient

A. COMMON OBSTACLES IDENTIFIED IN THE UNITS
x 24-hour window for recruitment x High stress level in subjects and relatives x Incorporation of 2-3 different staff shifts to conduct research protocols rather than efforts to conduct research with a regular team on a single shift x Timing for research approach prior to standard of care practice implementation x Length of the informed consent forms x Critical state of potential subjects x Simultaneous approaches to participate in different protocols

B. ADDITIONAL TRAINING NEEDS IDENTIFIED BY CRCs
x Commonly utilized skill sets (e.g., EKG's, phlebotomy, specimen processing, lab safety, responsible conduct of research) that may be required off-site.
x Writing (basic writing skills if needed in addition to document preparation including adverse and safety event reporting, and summary preparation).
x Compliance x Supervision x Navigation of the complex and fluctuating requirements for on-site research, recruitment, and participant concerns during the COVID-19 pandemic.
infrastructure to integrate them in specific environments, such as ICUs. The need for specific research team intervention and development, especially for off-site CRCs, to foster studies in unique populations has been noted in other areas, such as oncology. 7 The coronavirus disease 2019 (COVID-19) pandemic has also created new issues in participant recruitment, screening protocols, and space availability that have created an ever-shifting clinical research environment. [8][9][10] Coordinators' salaries are covered by a collaborative effort between the units and the CTSA grant. The CRR covers 50% and the respective unit covers the other 50%. A primary mentor from the relevant unit is assigned in each unit to each of the coordinators. Coordinator services are exclusive to the unit, but not to a specific investigator. Only an investigator within the unit is able to request their service. Each unit retains autonomy in determining the need for each CRR-supported coordinator to be oncall, similar to unit supervision of coverage for other team members.
The synergistic institutional and department support has been shown to play a major role in research coordinator satisfaction and decrease coordinator turnover 6,11 and is incorporated into this programming. Specifically, integration of coordinators into the ICU and subspecialty care units has been addressed by collaboration with the Neonatal Intensive Care Unit, Pediatric Intensive Care Unit, Pediatric Emergency Department, Adult Emergency Department, Medical Intensive Care Unit, Obstetrics and Gynecology, and Neurology Intensive Care Unit to implement this off-site research program. Off-site coordinators are permanently based in each of these units, thus providing the opportunity to actively participate and learn how to incorporate research activities into daily practices and patient care. Programming is designed to integrate the coordinator with active members of the unit staff under the guidance and mentorship of an identified experienced investigator who is already a collaborator within these ICU and specialty care units.
The Joint Task Force for Clinical Trial Competency 12,13 has recommended eight general core competencies for an effective research coordinator. However, this list needs to be adapted to address the additional complexity of many off-site studies, especially in specialty units and ICUs. Implementation of clinical research protocols in high-risk units require specific skills that are not directly addressed in the Joint Task Force competencies. Specifically, the program includes a formal designation of protocol-specific complexity and necessary coordinator training needs to be established to identify and address the additional skill sets that are needed to function in these off-site units. Figure 3, program goals are divided into two basic components: education and retention. These are very much inter-related. Hornung et al 14 reported that the degree of self-perceived confidence in performance of advanced tasks, such as regulatory affairs, in recent graduates of formal CRC training programs was equivalent to as much as 5 years of experience in a research-intensive CTSA and 10 years of experience in community settings. In the Clinical Research Associate Retention Study, 15 lack of professional development was associated with greater likelihood of attrition among associates. Similarly, Buchanan et al., 5 reported that professional support and relationship with the principal investigator, both of which are fostered by on-site training opportunities, are key items in fostering CRC retention. This program is different from that for institutional CRCs who are assigned to a specific department/unit and to an individual PI, usually with little consideration of skills and competencies regardless of protocol complexity. Training is determined by each unit and may or may not consider coordinator's feedback. CRR F I G U R E 3 Summary of intervention goals in education and retention of CRCs. The program recognizes the obstacles faced by the coordinators to implement research protocol within their units and identified those that would be diminished by specific training. Other obstacles related to infrastructure and unit logistics (see Figure 2) are documented and addressed at the administrative level. Training topics are selected from coordinators feedback on potential benefit. Programming is divided into two basic components: education and retention. Formal education is key. Hornung et al. 15 reported that the degree of self-perceived confidence in performance of advanced tasks such as regulatory affairs in recent graduates for formal CRC training programs was equivalent to as much as 5 years of experience in researchintensive CTSA and 10 years of experience in community settings. COVID-19, coronavirus disease 2019; CRC, Clinical Research Coordinator; CTSA, Clinical Translational Science Award.

PROGRAM GOALS
A. Education: x Implementation of research protocols without disruption of regular subspecialty unit workflow and minimize unit clinical care staff burden.
x Understanding means to maximize safe research practices and minimize participant burden including avoidance of multiple trial enrollment.
x Disseminating information regarding changing hospital requirements for participant screening, eligibility, and space availability during the COVID-19 pandemic and assist CRCs in implementing these shifting requirements.

B. Retention:
x Integrate coordinators into active specialty unit members and collaborators under the guidance of investigators already established within the unit infrastructure.
x Create an environment in which the CRCs are respected and engaged with the investigators and specialty units to promote job performance, satisfaction, and CRC retention 5 .
CRCs are offered additional support and tailored interventions to identified needs. Additionally, CRR coordinators are frequently assessed and offered additional training relevant to their daily activities.

PROGRAM IMPLEMENTATION
CRCs are given a bimonthly seminar series to familiarize them with more general aspects of Columbia University Medical Center resources (see Figure 4). The seminar series includes relevant research topics that can reinforce successful coordinator activities and supports CRR retention at a group level by encouraging interactions between CRCs and can reinforce successful coordinator activities. Support and training activities include monthly educational sessions (see Figure 4) which are more individualized than the bimonthly seminars and aim to provide the off-site coordinators with the recommended skills and competencies necessary for successful research implementation. The off-site coordinators also establish inter-unit collaborations to implement best practices and problem solving. CRCs, and other study personnel, are offered monthly education sessions that address some of the obstacles noted in Figure 2 and provide opportunities to enhance their research skill set and study participation. These sessions are taught by the CRR-clinical research manager.
The program intends to recognize the obstacles faced by the coordinators to implement research protocols within their units. Some of these obstacles may benefit from specific training. Others related to infrastructure and unit logistics are documented and addressed at the administrative level. Training topics are selected from coordinators' feedback on potential benefit. The programming goals are unique to the CRR in consideration of the daily coordinator workload and ability to carry out frequent research tasks listed on research protocols. The training sessions and seminar series aim to provide the ability to carry out those tasks independently.
Administrative efforts geared to provide the necessary knowledge and tools to the coordinators, not only facilitate research implementation (education), but also reinforce team collaboration and satisfactory work experiences (retention). 5 The mentorship provided by the embedded investigator supports, promotes, and creates documentations that validates all the valuable contributions made by the coordinators. The coordinator interacts with physicians, nurses, allied health professionals, students, and attends rounds and research meetings. As active members of each of the units, the off-site coordinators become the gatekeepers for research implementation.
To further promote and incentivize professional growth, the CRR has partnered with established research organizations to educate and guide the off-site coordinators through the professional credentialing process. In addition to the ongoing seminars offered above, off-site coordinators meet weekly with the CRR research nurse manager and CRR administrative director and associate director to review progress for individual protocols, to attempt to reduce the obstacles listed in Figure 2, and to provide an in-depth protocol review which could be shared with the clinical teams in the specialty units. During these meetings, good clinical practice is reviewed, and new or unique obstacles, such as any changes in participant screening requirements or space availability due to the COVID-19 pandemic, are identified. Data collection in each of the units, including specific protocol information, census, and participant deployment are also discussed.
The major work product is the successful implementation of this programming as described above. Additional work product includes a monthly census, which is provided to the CRR directors and a monthly meeting of all CRCs to review ongoing progress and activities in each of the units. These meetings are used to identify potential

SEMINAR SERIES:
x Research pharmacy (CUIMC resource) x IRB: submission and approval, adverse event reporting (CUIMC-CTO resource) x Electronic Informed Consent (CTO resource) x Anthropometric Measures (Bionutrition CTSA resource) x Research professional organizations (Research Professional Accreditation) x Recruit Me (Electronic recruitment tools-CUIMC resource) x ClinicalTrials.gov [trial registration process and CUIMC-clinical trials office (CTO) resource] x Clinical Trials Budgeting (CUIMC-CTO resource) x Virtual Pharmacy (CUIMC Research Pharmacy) EDUCATION SESSIONS: x 12 Lead EKG x Phlebotomy x Lab sample processing x Lab safety x Responsible conduct of research areas of improvement for off-site CRCs and are discussed with the CRR directors, each unit's administrator and the CRR clinical manager. Qualitative data are collected regarding individual protocols that are collected through interviews with the coordinators using open questions to address progress and emergent issues. Specific protocol census and participant deployment are also discussed. Recommendations on how to improve research that came out of these meetings are summarized in Figure 5.

DISCUSSION
This is a focused program to facilitate the ability of CRCs to work collaboratively with critical care, emergency, or other healthcare providers, navigate the additional institutional review board and other administrative requirements in these research settings, and maintain the highest level of awareness of participant burden in these often clinically unstable populations. This is part of an overall goal of leveraging multiple CRR-based resources to the conduct of original clinical and translational science in multiple venues. This program is presented as a potential means of enhancing clinical research in these critical environments, and other area, through improved CRC engagement.
Specifically, an organized program for CRCs to acquire the necessary skills for these research sites is key to successful clinical research in an expanded number of venues. 11 This program addresses the need for better training and assessment tools for CRCs which is recognized by both the investigators 12 and CRCs. 4 It also creates a fluid and rapidly implementable system for informing CRCs of changes in hospital policies that may affect participant retention and recruitment as exemplified by the pandemic.

RECOMMENDATIONS FOR IMPROVEMENT
x Flexible coordinator schedules to cover most of the day and night shifts.
x Identification of unit nurses or other staff (hospitalists, surgical or clinical assistants) champions that will enable and promote research collaboration, implementation and sensitization.
x Use of electronic informed consent x Reinforcement of good clinical practice (GCP) x Internal unit coordination for consent maximization x Constant sensitization and empathy towards subjects' and relatives' condition.

Program component
How structured As noted, the need for off-site CRCs acting in multiple locales, including ICUs, has intensified. This program eases the transition to the expanded roles of the CRCs in complex, off-site, CTSA research. In addition, Integration of the CRCs with all aspects of investigators and fostering of a collaborative respectful, un-siloed, teams are premonitory of CRC retention. 5 Future assessments of this program will be based on data collection regarding program satisfaction and skill set assessments from CRCs as well as CRC and research evaluations from the clinical staff of the specialty units and study principal investigators. In addition, publications from the ICU and specialty care units citing the CTSA grant will be evaluated based on number, fraction of total institutional publications citing the CTSA grant, and number of publications listing the CRCs as co-authors or acknowledging their participation which are already a part of routine CTSA/CRR quality reviews. Standardized assessments of CRC perceived and actual competency 4,12,13 will be used to identify areas in which further program development are needed and CRC retention will be monitored.

CONCLUSIONS
The off-site coordinator program embeds CRCs and has facilitated the implementation of research protocols in traditionally complex areas like ICU and emergency departments. Investigator initiated research protocols and protocols with limited logistic support have directly benefited from the incorporation of this coordinator model within the units. Embedded coordinators create bonds with the units' staff promoting order, research culture, and organization that facilitates the incorporation of research protocols into the daily workflow.
Future assessments of this program will be based on data collection regarding program satisfaction and skill set assessments from CRCs as well as CRC and research evaluations from the clinical staff of the specialty units and study principal investigators. In addition, publications from the ICU and specialty care units citing the CTSA grant will be evaluated based on number, fraction of total publications citing the CTSA grant, and number of publications listing the CRCs as co-authors or acknowledging their participation which are already a part of routine CTSA/CRR quality reviews. Standardized assessments of CRC perceived and actual competency 4,12,13 will be used to identify areas in which further program development are needed and CRC retention will be monitored. Note that the program for resource integration and ongoing assessment can potentially be extended to other research venues (Table 1).