Core Competencies of Clinical Research Coordinators

Kohara, Izumi; Nosaki, Akiko; Morishita, Noriko; Ushirozawa, Nobuko; Endo, Kazushi; Yamada, Hiroshi; Taniguchi, Takao; Kusuoka, Hideo

doi:10.14257/ijbsbt.2017.9.2.01

Cited by 2 publications

(3 citation statements)

References 4 publications

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“…Study coordinators play a critical role in research involving people with memory deficits or early dementia, facilitating the recruitment, IC, and retention of research participants. They present the principles of the research study, explain the procedures, answer questions from potential participants, and often engage participants' caregivers or LAR (Kohara et al 2017). Coordinators are at the front lines, balancing advocacy for the research itself against protection of participants from undue influence (Davis et al 2002).…”

Section: Introductionmentioning

confidence: 99%

Informed Consent in Two Alzheimer’s Disease Research Centers: Insights From Research Coordinators

Suver

Hamann

Chin

et al. 2020

AJOB Empirical Bioethics

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Background: Informed consent (IC) is critical to performing ethical research. Unfortunately, the IC process and supporting IC forms are frequently burdensome and do not necessarily meet the informational needs of participants. The intersecting legal and ethical challenges of obtaining IC from individuals with memory or cognitive deficits further exacerbate existing IC shortcomings. For this reason, study coordinators play a critical role in facilitating the IC process in Alzheimer's disease (AD) research. To identify opportunities to improve how IC is obtained in AD research, we examined the IC process from the perspectives of study coordinators at two Alzheimer's Disease Research Centers (ADRC). Methods: We performed semi-structured interviews with 15 study coordinators from two ADRC sites detailing their experience obtaining IC. Interviews were conducted in private, recorded, transcribed, and independently coded using the constant comparative method of grounded theory. Key themes were explored as they emerged. Results: Coordinators reported overall satisfaction with the IC process. However, many reported difficulties maintaining participant attention, explaining complex procedures, and addressing medical misinformation. Although the centers use site-specific consent forms, coordinators at both centers stressed that their IC is too long and the supporting IC forms are too complicated. Coordinators indicated modifying the IC process to the perceived needs of individual participants. Adaptations reported include altering the cadence and vocabulary they employ, using supplemental materials, varying the order of IC topics, and limiting the depth of information presented. Conclusion: A qualitative analysis of interviews with study coordinators reveals opportunities to improve how we obtain IC in AD research. These insights will be used to create an electronic informed consent (eConsent) designed to boost engagement, enhance trust, and improve understanding by supporting participants' direct agency in the IC process.

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Section: Introductionmentioning

confidence: 99%

Informed Consent in Two Alzheimer’s Disease Research Centers: Insights From Research Coordinators

Suver

Hamann

Chin

et al. 2020

AJOB Empirical Bioethics

View full text Add to dashboard Cite

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“…Research coordinators (variably titled study coordinators, research associates, research assistants, research specialists, trial managers, and other similar) are professional managers and facilitators of translational and clinical research. Responsibilities vary with the research portfolio being managed and commonly include protocol development, subject recruitment, budgeting, monitoring, data management, bio-banking, follow-up, and regulatory duties, among others 1–5 . As clinical trials become more complex, dedicated professional study personnel are essential to effectively navigate the increasing regulatory and administrative burdens required to successfully deliver high-quality research 3 …”

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confidence: 99%

“…Responsibilities vary with the research portfolio being managed and commonly include protocol development, subject recruitment, budgeting, monitoring, data management, bio-banking, follow-up, and regulatory duties, among others. [1][2][3][4][5] As clinical trials become more complex, dedicated professional study personnel are essential to effectively navigate the increasing regulatory and administrative burdens required to successfully deliver high-quality research. 3 Despite their vital role within the research infrastructure, the research coordinator's role is poorly defined, their contributions underrecognized, and their training nonstandardized.…”

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confidence: 99%

Perceptions of the Research Coordinator Role Among Interventional Pulmonology Researchers

Roller,

Lentz,

Maldonado

2023

Journal of Bronchology &Amp; Interventional Pulmonology

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R esearch coordinators (variably titled study coordinators, research associates, research assistants, research specialists, trial managers, and other similar) are professional managers and facilitators of translational and clinical research. Responsibilities vary with the research portfolio being managed and commonly include protocol development, subject recruitment, budgeting, monitoring, data management, bio-banking, follow-up, and regulatory duties, among others. [1][2][3][4][5] As clinical trials become more complex, dedicated professional study personnel are essential to effectively navigate the increasing regulatory and administrative burdens required to successfully deliver high-quality research. 3 Despite their vital role within the research infrastructure, the research coordinator's role is poorly defined, their contributions underrecognized, and their training nonstandardized. 3,6,7 Relatedly, there is a high prevalence of burnout and turnover among research coordinators, with obvious implications for ongoing studies as well as the cost to institutions to retain, recruit, and train new personnel. 6,8 Many perceive the role to be a temporary position, often viewed as a bridge to medical school, nursing positions, or other graduate programs, rather than a long-term career. 8 There is little data on investigator and coordinator perceptions of coordinator training, expectations, responsibilities, and career opportunities and, specifically, no data specific to interventional pulmonary. We developed a survey to characterize the landscape of responsibilities, scope of work, job satisfaction, and career opportunities for interventional pulmonology study coordinators. METHODS An online REDCap survey (see SupplementalDigital Content, Supplemental Digital Content 1, http://links.lww.com/LBR/A306) was distributed through email to the members of the American Association of Bronchology and Interventional Pulmonology and their respective coordinators. Those with current or recent participation in research as an investigator or research coordinator were invited to participate. Data pertaining to perceptions of coordinator training, responsibilities, and retention were obtained. [7][8][9][10] Visual analog scales with 0 indicating no agreement and 100 indicating maximal agreement with a given statement were used; this scale was chosen for easy implementation within an online survey. Betweengroup comparisons with χ 2 and student t-test were performed for categorical and continuous variables, respectively, with the assumption of normal distribution for continuous variables (JASP 0.16.1, Amsterdam, Netherlands). RESULTSOf the 634 people who viewed the survey invitation from the AABIP mailing list, 72 responses were received (32 coordinators, 40 investigators). See Table 1 for detailed respondent demographics. Response rate could not be discretely calculated as it

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Core Competencies of Clinical Research Coordinators

Abstract: Abstract

Cited by 2 publications

References 4 publications

Informed Consent in Two Alzheimer’s Disease Research Centers: Insights From Research Coordinators

Informed Consent in Two Alzheimer’s Disease Research Centers: Insights From Research Coordinators

Perceptions of the Research Coordinator Role Among Interventional Pulmonology Researchers

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