Clinical Trials Team Manager
Company: Yale University
Location: New Haven
Posted on: February 22, 2021
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Job Description:
Comprehensive Cancer Center - Clinical Trial Operations 63788BR
University Job Title Manager, Clinical Trial Disease Team
Bargaining Unit None - Not included in the union (Yale Union Group)
Time Type Full time Duration Type Regular Compensation Grade
Clinical & Research Compensation Grade Profile Manager, Clinical
Trial Disease Team (M5) Work Location Medical School Campus Work
Week Standard (M-F equal number of hours per day) Searchable Job
Family Research Res Support, Research/Support Total # of hours to
be worked: 37.5 Position Focus: Yale Cancer Center is Connecticut's
only cancer center designated as a Comprehensive Cancer Center by
the National Cancer Institute (NCI). Yale Cancer Center delivers
the highest quality patient-centered care, achieves breakthrough
discoveries, and trains the future leaders in cancer science and
medicine. There are over 300 clinical trials providing the most
advanced cancer therapies at Smilow Cancer Hospital and in the 15
Care Centers, and trials are available within 20+ disease units.
Yale has been at the forefront of understanding the fundamental
mechanisms of cancer biology and in developing effective therapies
for the treatment of cancer, and harnesses the resources of the
Yale School of Medicine and Smilow Cancer Hospital at Yale-New
Haven to advance cancer research, prevention, and patient care, as
well as community outreach and education.
Working under the direction of the Assistant Director for Clinical
Research, manages Disease Aligned Research Team (DART) staff and
ensures appropriate infrastructure to conduct clinical trials in
accordance with the study protocol and applicable policies and
regulation while ensuring participant safety. Collaborates with
DART Leader and Principal Investigator (PI) on assessment and
implementation of highly complex trials for the research team.
Manages oversight of protocol conduct and ensures that research
site personnel and investigators, are conducting the study per the
protocols and Good Clinical Practice guidelines. Monitors federal
and state regulations for new guidance, updates, or policies. 1.
Manages and monitors policies, practices and procedures of licensed
and unlicensed staff in their assigned translational working group
(includes C&T and M&P staff). 2. Ensure infrastructure to
conduct clinical trials by evaluating the clinical, physical,
technological, and staff resources required to ensure each clinical
trial can be conducted in accordance with the study protocol,
applicable policies and regulation while ensuring participant
safety. Includes assigning nursing and research support staff to
the disease team specific clinical trials. 3. Hires, trains,
supervises and evaluates staff providing direction, training,
support on a variety of research topics, including but not limited
to: Informed Consent, enrolling study subjects, data management and
monitoring/auditing of studies. 4. Collaborate with Therapeutic
Working Group Leader (TWG) and Principal Investigator (PI) on
assessment and implementation of highly complex trials for the
research team. Includes identifying accrual targets, study
activation timelines and metrics and resolving potential
discrepancies and/or barriers to enrollment by prior to study
activation. 5. Implements and manages internal practices of
assigned translational working group that ensure compliance with
University and federal requirements. 6. Manage oversight of
protocol conduct and ensure that research site personnel and
investigators, are conducting the study according to the protocols
and Good Clinical Practice guidelines. Monitors federal and state
regulations for new guidance, updates, or policies. Maintains a
high degree of knowledge on these requirements to determine actions
and follow directives that may be required to ensure University
compliance with congruency review and reporting requirements. 7.
Coordinates, oversees and participates in meetings including but
not limited to Pre-study Visits, Site Initiation Visits, Monitoring
visits, Multi-disciplinary Team meetings, staff meetings. 8.
Liaison between the Grants and Contracts offices, investigators,
and business managers to resolve congruency issues in a timely
manner for projects within their assigned translational working
group 9. Liaison between clinical and non-clinical related
departments to resolve congruency issues in a timely manner for
protocols/projects within their assigned translational working
group.-- Required Education and Experience Bachelor's degree in a
relevant academic/scientific field and a minimum of 4 years of
experience in clinical trials research or the equivalent
combination of education or experience. Required Skill/Ability 1:
Proven ability to manage and monitor the policies, practices and
procedures of licensed and unlicensed staff. Proven ability to
develop specific short- and long-term objectives for staff.
Required Skill/Ability 2: Demonstrated ability to ensure
appropriate infrastructure by evaluating the clinical, physical,
technological, and staff resources required to ensure each clinical
trial can be conducted in accordance with the study protocol,
applicable policies, and regulation while ensuring participant
safety. Required Skill/Ability 3: Strong knowledge of Good Clinical
Practice guidelines. Proven ability to interpret federal, state,
university and sponsor policies and regulations. Proven ability to
interpret complex oncology clinical trial protocols and federal,
state, local guidelines. Required Skill/Ability 4: Proven ability
to manage several projects concurrently, while balancing competing
priorities and deadlines. Extreme flexibility in work focus;
ability to switch among several different projects without any
adverse effects. Required Skill/Ability 5: Demonstrated ability to
report on the status of project deliverables and draft and submit
project updates to Yale team and study sponsor. Preferred
Education, Experience and Skills: Preferred Licenses or
Certifications: Certified Clinical Research Professional (CCRP)
preferred. Occasional Occasional Drug Screen No Health Screening No
All candidates for employment will be subject to pre-employment
background screening for this position, which may include motor
vehicle, DOT certification, drug testing and credit checks based on
the position description and job requirements. All offers are
contingent upon the successful completion of the background check.
Please visit www.yale.edu/hronline/careers/screening/faqs.html for
additional information on the background check requirements and
process. Posting Disclaimer The intent of this job description is
to provide a representative summary of the essential functions that
will be required of the position and should not be construed as a
declaration of specific duties and responsibilities of the
particular position. Employees will be assigned specific
job-related duties through their hiring departments. Affirmative
Action Statement: 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. Title IX of the Education Amendments of
1972 protects people from sex discrimination in educational
programs and activities at institutions that receive federal
financial assistance. Questions regarding Title IX may be referred
to the University's Title IX Coordinator, at TitleIX@yale.edu, or
to the U.S. Department of Education, Office for Civil Rights, 8th
Floor, Five Post Office Square, Boston MA 02109-3921. Telephone:
617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email:
ocr.boston@ed.gov. Note Yale University is a tobacco-free
campus
Keywords: Yale University, New Haven , Clinical Trials Team Manager, Healthcare , New Haven, Connecticut
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