January 19, 2016 The Collaboration for Research Integrity and

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January 19, 2016
The Collaboration for Research Integrity and Transparency (CRIT) is now accepting
applications for four key staff members. CRIT is a new interdisciplinary initiative,
jointly led by the Yale Global Health Justice Partnership (GHJP), the Media Freedom
& Information Access Clinic (MFIA), and the Center for Outcomes Research and
Evaluation (CORE) at Yale-New Haven Hospital. We are seeking:



A program director
Two research and advocacy fellows, and
A staff attorney
Yale University considers applicants for employment without regard to, and does
not discriminate on the basis of, an individual's sex, race, color, religion, age,
disability, status as a veteran, or national or ethnic origin; nor does Yale
discriminate on the basis of sexual orientation or gender identity or expression.
The Collaboration for Research Integrity and Transparency (CRIT)
CRIT is a new collaboration that will be launched at Yale in July 2016. CRIT’s
mission is to ensure that the evidence base that supports decision-making regarding
pharmaceuticals and other medical products is accurate, comprehensive, and
accessible. The initiative aims to strengthen the integrity of the research used to
make decisions about medical products by ensuring the data are both rigorous and
reliable, by promoting full access to all clinical trial information, and by supporting
independent research and analysis of those data. It also will work to achieve a legal
and regulatory environment that supports the production and sharing of high
quality data. CRIT will undertake academic research, advocacy, and litigation to
inform and shape the policy environment in this area.
For more information about CRIT and its partner organizations, see [web link to
blurb about CRIT, which will link to MFIA, CORE, GHJP sites]
CRIT Program Director Opening
In collaboration with CRIT faculty leaders, the Program Director will be responsible
for overseeing the implementation and development of the CRIT.
S/he will,
coordinate the efforts of the various team-members, manage the budget, and
facilitate the collaboration’s work.
Duties include:

Coordinating the efforts of the CRIT team (which includes faculty across
several schools at Yale, four additional staff members, and student
assistants),

Directly supervising the full-time CRIT administrator

Developing and managing the program budget

Coordinating weekly or biweekly CRIT meetings for staff and faculty, as well
as longer-range strategic planning processes at least once each year.

Leading in the planning and execution of an annual symposium on research
integrity and transparency at Yale, and a regular seminar series on related
issues (meeting approximately five times a year).

Facilitating convening of an advisory committee at least annually

Working with the administrator and business office to perform financial
forecasting and monthly expenditure oversight

Assuring appropriate and optimal utilization of various restricted sources of
funding, and leading CRIT development and grant reporting activities.

Leading in the management of an internal small grants fund, which will seek
applications for, and award and oversee reporting on, a series of small
research grants available to faculty working on issues of relevance to the
CRIT.

Working with colleagues across the campus on related work on data integrity
and transparency

Developing relationships with outside collaborators, including other
organizations working on data transparency and quality.
Applicants should have a bachelor’s degree; at least five years of work experience; a
proven track record as a supervisor; proven administrative and organizational
expertise; and budget-management experience. Graduate training preferred. The
director will be encouraged to contribute, in addition, to the substantive work of the
center, via publishing and public speaking engagements, and should have superb
oral and written communications skills, interpersonal and presentation skills, and
the ability to work effectively with a wide variety of constituencies.
This position starts on July 1st, 2016, or possibly sooner. Salary range: $70,000 $87,500, depending upon qualifications, plus excellent health and retirement
benefits and access to university facilities. This position is initially funded for three
years and we will be applying for funding renewal. You can view University benefits
at: http://www.yale.edu/hronline/benefits/index.html.
CRIT Research and Advocacy Fellows
The CRIT research and advocacy fellows will undertake original research related to
the central concerns of the project and aim to publish the results in both academic
and non-academic fora. The fellows will be directly supervised by GHJP and CORE
faculty and staff, with one fellow based in GHJP and one at CORE. Both fellows will
be mentored by faculty drawn from Yale’s law, public health and medical schools,
and will in turn help mentor Yale students interested in these topics.
The ideal candidates will have professional training in law, medicine, and/or public
health; as well as experience translating academic work into policy circles. She or he
will be an excellent writer and communicator and have an interest in data integrity
and transparency and in drug, medical device or biologics research, development
and regulation. Familiarity with the FDA and First Amendment law and prior
research experience are an advantage.
The fellow will receive tailored training in research methods, and may attend
relevant courses in the law, medical, and public health schools. Key duties will
include:



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Developing publishable papers that address, for example, policy, regulatory
and legal barriers to ensuring that research of pharmaceuticals and medical
devices is accurate, comprehensive, and accessible; or policy or legal
measures to remedy existing barriers
Developing publishable papers that document, for example, reasons for and
problems associated with the lack of transparency, of clinical research data;
or the association clinical implications of this lack of transparency
Producing policy papers and briefings, to disseminate CRIT research and
shape policy and law reform recommendations in appropriate areas
Facilitating CRIT’s advocacy and policy work generally, including by
travelling to conferences and policymaking settings, and assisting the CRIT
staff attorney with amicus briefs and other legal advocacy work
The fellow will be part of the larger CRIT staff and may assume responsibility for
other shared work from time to time (e.g. organizing events and seminars).
This position starts on July 1st, 2016, and will be for one year, renewable on mutual
agreement for up to three years. Salary range: $60,000 - $75,000, depending upon
qualifications, plus health and retirement benefits and access to university facilities.
You
can
view
University
benefits
at:
http://www.yale.edu/hronline/benefits/index.html
CRIT Staff Attorney Opening
The staff attorney will be a member of both CRIT and the MFIA Clinic, with
responsibility to develop and implement legal strategies that will increase
transparency for clinical trials involving drugs, biologics and medical devices. At
least five years of previous litigation experience is required; knowledge of FOIA,
FDA drug approval policies and practices, clinical testing design and ethics,
administrative procedure law, or First Amendment is preferred.
Under the supervision of MFIA director David Schulz, the staff attorney will work
with CRIT faculty drawn from Yale’s law, public health and medical schools to devise
and implement strategies that can achieve a significant systematic impact on access
to clinical trial data, and that can shape the quality of clinical trial data produced.
These strategies may include such steps as initiating litigation to enforce clinical
reporting requirements, pursuing FOIA litigation, petitioning for FDA regulatory
reforms, and coordinating with private and government attorneys. Activities may
also include amicus work in cases of importance to CRIT issues, for example,
involving First Amendment challenges to the FDA’s regulatory authority.
To implement these strategies, the staff attorney will have the assistance of Yale law
students in the MFIA Clinic, and another licensed attorney who serves as a MFIA
fellow. In his or her role as a supervising attorney in the Clinic, the CRIT staff
attorney will play a significant role in training a new generation of lawyers to be
both excellent advocates and future leaders in this area of the law. The staff
attorney will supervise students on all active Clinic cases undertaken in support of
CRIT’s mission, and teach a number of substantive and skill-based sessions each
semester.
The staff attorney will also be able to participate in the scholarly activities of the
MFIA, and its parent organization, the Information Society Project (ISP), directed by
Knight Professor of Constitutional Law And the First Amendment Jack Balkin. ISP
activities include regular academic lunches, workshops, conferences, and talks.
This position starts on July 1st, 2016. Salary range: $100,000 to $130,000,
depending upon qualifications, plus health and retirement benefits and access to
university
facilities.
You
can
view
University
benefits
at:
http://www.yale.edu/hronline/benefits/index.html
Applications
Review of applications for all positions will begin on February 15, 2016, and
continue thereafter until the positions are filled.
Application materials should include:
For the program director:

A one to three page statement describing the applicant’s interest in the
position and relevant experience;

A copy of the applicant’s resume or CV;

Transcripts from undergraduate and any relevant professional school; and
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At least one sample of recent written work;
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Contact information for three references, at least two of which can speak to
the candidate’s professional experiences
For the GHJP research and advocacy fellow:

A one to three page statement describing the applicant’s interest in the
position and relevant experience;
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A copy of the applicant’s resume or CV;

Transcripts from undergraduate and any relevant professional school; and

At least one sample of recent written work;

Contact information for three references
For the CORE research and advocacy fellow:

A one to three page statement describing the applicant’s interest in the
position and relevant experience;

A copy of the applicant’s resume or CV;

Transcripts from undergraduate and any relevant professional school; and

At least one sample of recent written work;

Contact information for three references
For the staff attorney:

A one to three page statement describing the applicant’s interest in the staff
attorney position and relevant practice experience;
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A copy of the applicant’s resume;
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A law school (and any graduate school) transcript; and
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At least one sample of recent legal writing, preferably a brief or
memorandum.
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Contact information for three references
**Please indicate clearly in the application materials the position for which you
are applying **
Further information about CRIT is available at http://www.yaleghjp.org/#!crit/cgu.
Contact Meredith Berger with any questions, at (203) 432-3283 or
meredith.berger@yale.edu. Application materials should be sent (in electronic
form) to crit.admin@yale.edu and meredith.berger@yale.edu.
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