dismissed EB-1A Case: Medical Science

U.S. Citizenship 
and Immigration 
Services 
MATTER OF R-P-
Non-Precedent Decision of the 
Administrative Appeals Office 
DATE: AUG. 25,2017 
APPEAL OF NEBRASKA SERVICE CENTER DECISION 
PETITION: FORM 1-140, IMMIGRANT PETITION FOR ALIEN WORKER 
The Petitioner, a medical scientist, seeks classification as an individual of extraordinary ability in the 
sciences. See Immigration and Nationality Act (the Act) section 203(b)(l)(A), 8 U.S.C. 
§ 1153(b )(1 )(A). This first preference classification makes immigrant visas available to those who 
can demonstrate their extraordinary ability through sustained national or international acclaim and 
whose achievements have been recognized in their field through extensive documentation. 
The Director of the Nebraska Service Center denied the Form 1-140, Immigrant Petition for Alien 
Worker, concluding that the Petitioner had satisfied only one of the initial evidentiary criteria, of 
which he must meet at least three. 
On appeal, the Petitioner submits a brief and additional evidence. He contends that he meets six of 
the required criteria and possesses the required level of expertise for this classification. 
Upon de novo review, we will dismiss the appeal. 
I. LAW 
Section 203(b)(l)(A) ofthe Act states: 
Aliens with extraordinary ability. -- An alien is described in this subparagraph if-
(i) the alien has extraordinary ability in the sciences, arts, education, business, or 
athletics which has been demonstrated by sustained national or international 
acclaim and whose achievements have been recognized in the field through 
extensive documentation, 
(ii) the alien seeks to enter the United States to continue work m the area of 
extraordinary ability, and 
(iii) the alien's entry into the United States will substantially benefit prospectively the 
United States. 
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Matter of R-P-
The term "extraordinary ability" refers only to those individuals in "that small percentage who have 
risen to the very top of the field of endeavor." 8 C.F.R. § 204.5(h)(2). The implementing regulation at 
8 C.F.R. § 204.5(h)(3) sets forth two options for satisfying this classification's initial evidence 
requirements. First, a petitioner can demonstrate a one-time achievement (that is a major, 
internationally recognized award). Alternately, he or she must provide evidence that meets at least three 
of the criteria listed at 8 C.F.R. § 204.5(h)(3)(i)-(x) (including items such as awards, published material 
in certain media, and scholarly articles). 
Where a petitioner meets these initial evidence requirements, we then consider the totality of the 
material provided in a final merits determination and assess whether the record shows sustained 
national or international acclaim and demonstrates that the individual is among the small percentage 
at the very top of the field of endeavor. See Kazarian v. USC IS, 596 · F .3d 1115 (9th Cir. 201 0) 
(discussing a two-part review where the documentation is first counted and then, if fulfilling the 
required number of criteria, considered in the context of a final merits determination); see also 
Visinscaia v. Beers, 4 F. Supp. 3d 126, 131-32 (D.D.C. 2013); R?jal v. USCIS, 772 F. Supp. 2d 1339 
(W.D. Wash. 2011). This two-step analysis is consistent with our holding that the "truth is to be 
determined not by the quantity of evidence alone but by .its quality," as well as the principle that we 
examine "each piece of evidence for relevance, probative value, and credibility, both individually 
and within the context of the totality of the evidence, to determine whether the fact to be proven is 
probably true." Matter ofChawathe, 25 I&N Dec. 369, 376 (AAO 2010). 
II. ANALYSIS 
The Petitioner received his medical degree in 2000 from the in Croatia. He 
then earned a master's degree in health services management from the m 
2006. He subsequently joined a contract research organization 
providing outsourced clinical development services to the biotechnology and pharmaceutical 
industries. The record includes a company prospectus describing how has performed 
approximately 3300 clinical trials worldwide on six continents. The Petitioner currently serves as a 
clinical team manager where his duties include evaluating and selecting potential trial sites; initiating 
the clinical trial at investigative sites, instructing site personnel including physicians and medical 
scientists on the proper conduct of clinical trials; observing and conducting performance checks on 
site, including verifying serious adverse event reporting and reviewing and confirming the accuracy 
of collected data; determining the efficacy of the clinical trial; and, assessing the medication and 
treatment. 
As the Petitioner has not indicated or established that he has received a major, internationally 
recognized award, he must satisfy at least three of the alternate regulatory criteria at 8 C.F.R. 
§§ 204.5(h)(3)(i)-(x). In denying the Petition, the Director found that that the Petitioner met the 
judging criterion under 8 C.F.R. § 204.5(h)(3)(iv). On appeal, the Petitioner maintains that he also 
meets the following five criteria: published material, 1 original contributions, 2 authorship of 
I 8 C.F.R. § 204.5(h)(3)(iii). 
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scholarly, articles, 3 display at artistic exhibitions or showcases, 4 and leading or critical role5• We 
have reviewed all of the evidence in the record of proceedings, and it does not suppmi a finding that 
the Petitioner meets the plain language requirements of at least three criteria. 
A. Evidentiary Criteria 
Published material about the alien in professional or major trade publications or other 
major media, relating to the alien's work in the field for which class?fication is sought. 
Such evidence shall include the title, date, and author of the material. and any necessary 
translation. 8 C.F.R. § 204.5(h)(3)(iii). 
The Petitioner claims eligibility under this criteria based upon the publication of an article entitled ' 
published in 2015 in 
The article was subsequently 
published on the online version of the journal in 2016. This article was authored by the Petitioner and 
five co-authors and describes the culmination of the team's research developing computational tools for 
improving the safety and efficacy of clinical trials. While we do not dispute that is 
a form of major media, the article referenced is not about the Petitioner; rather, it is a peer-reviewed 
journal article reporting his findings.6 The plain language of the regulation requires that the items be 
"about" the Petitioner, relating to his work. Articles that do not discuss the Petitioner are not 
"about" him. Similarly, the Petitioner references two symposia presentations presented at the 
and the 
that he authored. The evidence does not show 
that these presentations are about the Petitioner, or that the symposia where they were presented are 
either major trade publications or other major media. As such, we find that the Petitioner has not 
met this criterion. 
Evidence of the alien's participation, either individually or on a panel, as a judge of 
the work of others in the same or an allied .field of specifzcation for which 
classifzcation is sought. 8 C.F.R. § 204.5(h)(3)(iv). 
The Petitioner also asserts that his experience as a clinical team manager for qualifies under 
this criterion. The Petitioner states that his duties include evaluating hospitals, physicians, and 
medical personnel in their performance in clinical trial protocols, and serving as the "sole arbiter" of 
whether the clinical trial will be utilized in assessing the medication or treatment. He also notes that 
2 8 C.F.R. § 204.5(h)(3)(v). 
3 
8 C.F.R. § 204.5(h)(3)(vi). 
4 8 C.F.R. § 204.5(h)(3)(vii). 
5 8 C.F.R. § 204.5(h)(3)(viii). 
6 The regulations contain a separate criterion regarding scholarly articles. 8 C.F.R. § 204.5(h)(3)(vi). Consistent with the 
regulatory requirement that a petitioner meet at least three separate criteria, we will generally not consider evidence relating to 
the scholarly articles criterion to satisfy this one. 
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Matter of R-P-
he oversees his staff of medical scientists who monitor each trial location including evaluating their 
job performance. 
Serving as a manager where part of one's job duties includes evaluating other professionals in the 
exercise of his or her duties does not equate to participation as a judge of the work of others in the 
field. The phrase "a judge" implies a formal designation in a judging capacity, either on a panel or 
individually as specified pursuant to the regulation at 8 C.F.R. § 204.5(h)(3)(iv). The regulation 
cannot be read to include every informal instance of evaluating subordinate employees. The record 
does not include evidence demonstrating that the Petitioner actually served "as a judge of the work 
of others." Incidental evaluation responsibilities inherent to a managerial position do not establish 
that the Petitioner served in an official capacity, either individually or on a panel, as "a judge" of the 
work of others. Accordingly, while the Director found th<~t the Petitioner satisfied this criterion, we 
disagree with that finding. 
Evidence of the alien ·s original scient(fic, scholarly, artistic. athletic, or business­
related contributions of major sign(ficance in the.field. 8 C.F.R. § 204.5(h)(3)(v). 
The Petitioner contends that he has made original contributions of major significance to the field 
through his clinical trial leadership for his presentations at symposia and conferences, and his 
work contributing to the development of an automated clinical trials system. The Director 
acknowledged this evidence, but found that it was not sufficient to demonstrate that the Petitioner's 
work constituted original contributions of major significance in the field. 
On appeal, the Petitioner maintains that 
that a number of experts and colleagues have offered 
testimony regarding his contributions of major significance. 7 For example , a senior 
clinical research associate with described how the Petitioner ' s "experience and 
knowledge makes him a valuable mentor and team lead." director of 
cardiomyopathy at the Croatia, noted that the 
Petitioner's "knowledge of ethical and scientific quality standards and rights" was "instrumental" to 
his career. associate clinical project manager at stated that she worked with 
the Petitioner on a clinical trial aimed at treating children with seizure disorders. She described how 
the Petitioner's "skill and expertise" "contributed to the success of the study." While the letters 
commend the Petitioner for his expertise in managing clinical trials they lack specificity regarding 
how his achievements have affected the field or how the asserted achievements are being used or 
reproduced within the field. While such letters are important in providing details about the 
Petitioner's role in various clinical trials, they do not establish his impact beyond his immediate 
circle of colleagues. 
The Petitioner also maintains that his work relating to the development of a remote monitoring plan 
designed to automate the clinical trials process should be considered a contribution of major 
7 
While we discuss only a sampling of these letters, we have reviewed and considered each one. 
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Matter of R-P-
significance. He does not provide details explaining the plan, or how it has impacted the field of 
clinical trials. 
Several of the letters also discuss the trial automation tool. chairman of the 
department of mathematics at the wrote that the Petitioner collaborated 
with his research team in 2011 to develop an automated tool used 
in clinical trials that would "detect 
and prevent discrepancies and mistakes as early as possible." He explained that their proposed 
model, known as is the "first step in achieving the automated 
tool," and that the Petitioner was an "essential architect" in its development. Similarly, 
associate professor at in Brazil, commented that the 
Petitioner's insight helped him develop the foundations for the construction of a clinical trial 
assistant. He stated that the Petitioner "greatly simplified the task of running a trial by utilizing a 
clinical trial assistant to automate some analysis and compliance checks informing and even 
predicting when some deviation could occur." He attested that the Petitioner's insights "led to the 
success of our work by helping us further develop and refine our languages building the foundations 
for the construction of the clinical trial assistant." While these letters discuss the "clinical trial 
assistant," they do not explain whether the tool was ultimately 
developed for commercial use, or 
whether it is now being implemented in the clinical trials process. Without additional detail 
explaining the Petitioner's accomplishments relating to this tool, the record does not adequately 
demonstrate that this work has made a significant impact on his field. 
On appeal, the Petitioner asserts that the fact that this work was introduced at an international 
conference and published in the conference proceedings along with numerous other participants, 
contributes to his eligibility under this criterion. Many professional fields regularly hold conferences 
and symposia to present new work, to discuss new findings, and to network with other 
professionals. Professional associations, businesses, educational institutions, and government 
agencies promote and sponsor these conferences. Participation in these events, however, does not 
·necessarily reflect an original contribution of major significance in the field. The Petitioner has not 
demonstrated the impact of his findings after dissemination to the field at the conferences. 
Finally, the evidence does not demonstrate that the Petitioner has made contributions of major 
significance to the field as a whole; rather, his work is limited to advancing the clinical trials 
initiatives of his employer, The plain language of the regulation at 8 C.P.R. § 204.5(h)(3)(v) 
requires that the contributions be "of major significance in the field" rather than limited to one's 
immediate employer and a sampling of its customers or clients. See Visinscaia v. Beers, 4 F. Supp. 
3d at 134-35 (upholding a finding that a ballroom dancer had not met this criterion because she did 
not corroborate her impact in the field as a whole). Here, the record does not include documentary 
evidence showing the widespread commercial or industrial implementation of the Petitioner's work, 
that it has been seminal, or that it otherwise equates to an original contribution of major significance 
in the field. 
Evidence of the alien's authorship of scholarly articles in the .field. in professional or 
major trade publications or other major media. 8 C.P.R. § 204.5(h)(3)(vi). 
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Matter of R-P-
The Petitioner submitted evidence of his authorship of the article entitled ' 
· published in 
in 2015. This evidence satisfies the requirements ofthis criterion. 
Evidence of the display of the alien's work in the field at artistic exhibitions or 
showcases. 8 C.F .R. § 204.5(h)(3)(vii). 
The Petitioner indicates that the display of his work at scientific conferences and conference 
proceedings meets this criterion. Scientific conferences facilitate the dissemination of research 
among scientists and are not the same as artistic showcases or exhibitions designed to showcase 
artwork, as required by this criterion, nor is the Petitioner's work artistic in nature. Accordingly, the 
Petitioner has not met this criterion. 8 
Evidence that the alien has performed in a leading or critical role for organizations or 
establishments that have a distinguished reputation. 8 C.F.R. § 204.5(h)(3)(viii). 
The Director determined that the Petitioner did not establish that his role for was leading or 
critical. On appeal, the Petitioner contends that he performs in a leading and critical role for 
"where he leads advanced, high-stakes, multi-million dollar clinical trials of breakthrough 
medications and treatments on human test subjects." The record includes a letter from 
senior manager of clinical operations for who stated that the Petitioner "fills a critical need in 
our organization." She maintains that the Petitioner's role "contributes to the safety and well-being 
of study subjects who are treated on the clinical trials that [the Petitioner] manages." 
In general, a leading role is evidenced from the role itself, and a critical role is one in which a 
petitioner was responsible for the success or standing of the organization or establishment. The 
letter does not specify how the Petitioner's role fits into the hierarchy of the organization to show 
that it is a leading role. Further, while stated that the Petitioner has "a broad range of 
therapeutic expertise that few others in his role have," she does not clarify how the Petitioner's work 
is critical to the success and standing of the organization, or suggest the manner in which the 
Petitioner's work has resulted in a measurable level of success for The company literature 
contained in the record indicates that the company operates "on six continents across 13 time zones" 
and employs more than 12,000 employees. The evidence does not demonstrate when he assumed 
the role of clinical trial manager, how his role differentiates him from the numerous other clinical 
trial managers working for around the world, what percentage of trials he oversees, 9 or how the 
organization has progressed since the Petitioner began working there. 
8 Conference presentations are typically published in conference proceedings, serve the same purpose as scholarly 
articles in journals, and, therefore, generally fall under the scholarly articles criterion. We note that the Petitioner's 
initial brief included evidence of conference proceedings under the scholarly articles criterion. at 8 C.F.R. 
§ 204.5(h)(3)(vi). 
9 The Petitioner has provided conflicting information regarding the number of clinical trials that he has led. In the RFE 
response, he claimed that he has "led hundreds of trials;" yet, in the initial filing, he states that he "has led dozens of 
clinical trials," and on appeal, he states that he has "conducted 50 plus clinical investigations." Regardless, he has not 
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On appeal, the Petitioner contends that the record includes letters of support from employees 
establishing the leading or critical role that he plays for the organization. For example, 
a senior clinical research associate for describes how the Petitioner "expertly 
supervises" her team and indicates that his "knowledge of ethical and scientific quality standards and 
rights, safety, and well-being of patients involved is remarkable." Similarly, global 
project director for writes that the "vast knowledge and distinguished expertise of clinical 
research goes far beyond the average skills" of his peers, and that he "plays a crucial role in 
important clinical research studies and his projects would be seriously impaired without his 
invaluable contribution." While complementary of the Petitioner's skill in leading clinical trials, 
these letters fall short of specifying how the Petitioner contributed to the overall organization in a 
way that is significant to the organization's outcome. See Visinscaia, 4 F. Supp. 3d at 135. 
Overall, the letters do not demonstrate how the Petitioner served in a leadership role for the entire 
organization or establishment, nor do they demonstrate how the success of the organization or 
establishment itself is attributable to any critical role the Petitioner performed. The letters primarily 
contain unsupported assertions that the Petitioner's role was critical without sufficient explanation. 
Merely repeating the language of the statute or regulations does not satisfy the Petitioner's burden of 
proof. See Fedin Bros. Co., Ltd. v. Sava, 724 F. Supp. 1103, 1108 (E.D.N.Y. 1989), affd, 905 F. 2d 
41 (2d. Cir. 1990); Avyr Associates, Inc. v. Meissner, 1997 WL 188942 at *5 (S.D.N.Y.). 
Furthermore, the record does not sufficiently establish that possesses a distinguished reputation 
consistent with this regulatory criterion. While the Petitioner claims that, in 2015, was named 
clinical company of the year for the of 
the year for the second year in a row, the record does not include evidence of such accolades, or 
explain their significance. USCIS need not accept primarily conclusory assertions. See 1756. Inc. v. 
The Attorney General ofthe United States, 745 F. Supp. 9, 17 (D.C. Dist. 1990). 
B. Summary 
As explained above, the record only satisfies one of the regulatory criteria. As a result, the Petitioner 
has not submitted the required initial evidence of either a one-time achievement or documents that 
meet at least three of the ten criteria listed at 8 C.F.R. §§ 204.5(h)(3)(i)-(x)'-
Had the Petitioner satisfied at least three evidentiary categories, the next step would be a final merits 
determination that considers all of evidence in the context of whether or not the Petitioner has 
demonstrated a "level of expertise indicating that the individual is one of that small percentage who 
have risen to the very top of the field of endeavor," that the individual "has sustained national or 
international acclaim, and that his or her achievements have been recognized in the field of 
expertise." 8 C.F.R. § 204.5(h)(2), (3); see also Kazarian, 596 F.3d at 1119-20. Although we need 
not provide the type of final merits determination referenced in Kazarian, a review of the record in 
provided evidence explaining the specific impact that his clinical trial leadership has had on the overall organization. 
Matter_. of R-P-
the aggregate supports a finding that the Petitioner has not established the level of expertise required 
for the classification sought. Specifically, while the Petitioner has documented success leading 
clinical trials for his employer, along with publication of a peer-reviewed article, the evidence does 
not sufficiently demonstrate that he is in the small percentage at the top of the field or show the 
sustained national or international acclaim required for this highly restrictive classification. Nor 
does the record include extensive documentation showing recognition of the Petitioner's 
achievements in the field. 
III. CONCLUSION 
The Petitioner has not demonstrated that he qualifies as an individual of extraordinary ability under 
section 203(b)(1)(A) of the Act. Accordingly, he has not established eligibility for the immigration 
benefit sought. 
ORDER: The appeal is dismissed. 
Cite as Matter of R-P- ID# 551639 (AAO Aug. 25, 20 17)