Clinical Research Manager
Location: Louisville Kentucky
Description: Catholic Health Initiatives is currently interviewing Clinical Research Manager right now, this job will be placed in Kentucky. For detail informations about this job opportunity please read the description below. Job Summary
:
The role of the Research Manager is to provide leadership of all clinical trial activities at the research site. This role reports directly to the ! Associate Director of the CCR regarding all site operations, research engagements, and community program development. This position works closely with essential research constituencies (e.g. PIs, 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 Manager maintains a matrix relationship with the designated MBO research administrative contact.
Essential Duties:
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 resear! ch staff training and development.
Works with the stu! dy 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 personnel, including:
Participation in personnel interviews and selection processes
Responsible for orientation, training, and development of researc! h staff.
Conducts initial competency assessment of research personnel within 90 days of hire, transfer or promotion.
Provides ongoing communications (progress reports) to the CCR Associate Director regarding operations and site developments.
Contributes to projects that support the research site, CIRI and CCR organizational goals.
Qualifications
Education
:
a. Bachelor’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 preferred
Experience (required and preferred):
a. Minimum 3 years of demonstrated management experience required.
c! . Knowledge of key regulations regarding research transactions: CMS / FDA / OHRP / ORI / DHHS.
d. Understanding of Medicare billing rules and functional knowledge of essential National Coverage Decisions and the new CMS Clinical Research Policy (preferred)
e. Knowledge of drug/device development process and the pharmaceutical and/or medical device manufacturing industry is preferred.
f. Demonstrated ability to coordinate and establish priorities.
g. Effective organizational and time management skills.
h. Professional, team oriented attitude.
i. Excellent oral and written communication skills.
j. Ability to work independently and efficiently.
k. Sound judgment and analytical skills.
Catholic Health Initiatives and its organizations are Equal Opportunity Employers.CBCHI
Job
Research & Development
Primary Location
KY-Louisville
Shift
1
! Scheduled Hours per 2-week Pay Period
80
Weekends Required
None
Status
Full Time
- .
If you were eligible to this job, please email us your resume, with salary requirements and a resume to Catholic Health Initiatives.
If you interested on this job just click on the Apply button, you will be redirected to the official website
This job starts available on: Sun, 08 Sep 2013 14:01:25 GMT
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