Research Center Manager

Profile

Research Center Manager','Full-time','Director/Manager/Supervisor','Days','Days','80','80','None','None','COLORADO-ENGLEWOOD-DENVER INVERNESS','','!*!SummaryThe role of the Research Center Manager is to
provide leadership of all clinical trial activities at the research site. This
role reports directly to the System Director of CCR Operations, regarding all
site operations, research engagements, and community program development. This
position works closely with essential research constituencies (e.g. Private Investigators,
research coordinators, and other internal and external research-related parties
as needed) to ensure the efficient and compliant initiation and ongoing
administrative management and support of clinical research trials. The Research
Center Manager maintains a matrix relationship with the designated MBO research
administrative contact.Responsibilities
Serve as a central point of contact
for and liaison to the research community to provide guidance related to
the initiation and ongoing conduct of clinical research.
Accountable for all site research
activities including adherence to GCP guidelines, site timelines, quality
control and assurance of clinical trial data collection, clinical trial
drug/device management, clinical trial financial oversight, and research
staff training and development.
Works with the study team, CIRI and the CCR to
determine best practices for clinical research operations and study budget
accuracy.
Utilizes and maintains an effective system of
tracking both study and site information via the Clinical Trial Management
System (CTMS).
Recommends policies, procedures and processes
that promote efficiencies and drive quality assurance.
Ensures research site compliance
with relevant federal, state, and local regulations as well as CIRI, CCR
and institutional policies and procedures.
Manage the Research Site’s internal
finances and operating budget, including:

Completing an annual operating
budget for the research site.
Managing supply and labor expenses
(resource allocation) within budgeted targets.

Manage and oversee research site staff,
including:

Participation in staff interviews
and selection processes
Responsible for orientation,
training, and development of research staff.
Conducts initial competency
assessment of research staff within 90 days of hire, transfer or
promotion.

Provides ongoing communications (progress
reports) regarding operations and site developments.
Contributes to projects that support the
research site, CIRI and CCR organizational goals.
','!*!QualificationsBachelor’s
Degree in an applicable related field.  Minimum
5-7 years of overall related work experience, with three (3) of those years of relevant
experience in managing clinical trial studies.An
applicable related field may be the life sciences, business administration, management,
accounting, research administration, clinical trial study coordination, or
Research Nurse Management.Graduate
degree preferredMinimum
3 years of demonstrated management experience required.Knowledge
and understanding of ICH and GCP guidelines.Knowledge
of key regulations regarding research transactions: CMS / FDA / OHRP / ORI /
DHHS.Understanding
of Medicare billing rules and functional knowledge of essential National
Coverage Decisions and the new CMS Clinical Research Policy (preferred)Knowledge
of drug/device development process and the pharmaceutical and/or medical device
manufacturing industry is preferred.Demonstrated
ability to coordinate and establish priorities.Effective
organizational and time management skills.Professional,
team oriented attitude.Excellent
oral and written communication skills.Ability
to work independently and efficiently.Sound
judgment and analytical skills.','We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.','2018-R0144686','Catholic Health Initiatives - National Office','Research Center Manager

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