Position Type: Regular
Scheduled Hours per 2 week Pay Period: 80
Primary Location: NE > LINCOLN > EPN ST ELIZABETH
The 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.
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.
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.
b. Graduate degree preferred
c. Minimum 3 years of demonstrated management experience required.
d. Knowledge and understanding of ICH and GCP guidelines.
e. Knowledge of key regulations regarding research transactions: CMS / FDA / OHRP / ORI / DHHS.
f. Understanding of Medicare billing rules and functional knowledge of essential National Coverage Decisions and the new CMS Clinical Research Policy (preferred)
g. Knowledge of drug/device development process and the pharmaceutical and/or medical device manufacturing industry is preferred.
h. Demonstrated ability to coordinate and establish priorities.
i. Effective organizational and time management skills.
j. Professional, team oriented attitude.
k. Excellent oral and written communication skills.
l. Ability to work independently and efficiently.
m. Sound judgment and analytical skills.
Requisition ID: 2019-R0211822
Shift: Day Job
Market: CHI-Franciscan Harrison Medical Center
Catholic Health Initiative