Job Details:
 

Information about the position

Job Number:	6168
Job Title:	Clinical Data Specialist
Date Posted:	2/5/2010

Job Description:

Cincinnati Children’s Hospital and Medical Center Cincinnati Children’s Hospital Medical Center is ranked as the nation’s 7th best pediatric hospital by U.S. News & World Report. Furthermore, Cincinnati Children’s is continually chosen as a winner in the Cincinnati Business Courier's "Best Places to Work" competition, recently named to Hall of Fame. Cincinnati Children’s was honored as one of Parent’s magazine’s 10 Best Children’s Hospitals and is listed among the Leapfrog Top Hospitals. By hiring an elite team and providing them with exciting opportunities, extensive educational programs and leading edge technology, we’re ensuring career satisfaction – and creating an environment where children receive exceptional care. We offer an excellent salary and comprehensive benefits package. To obtain more information about our facility or to apply online via our career center, please visit www.cincinnatichildrens.org and forward your resume to Erin Lutz, HR Specialist at erin.lutz@cchmc.org. The Heart Institute Research Core (HIRC) In the 2008-2009 Fiscal Year, The Heart Institute (HI) began strategic planning for the Heart Institute Research Core (HIRC). The Vision of HIRC is "HIRC will accelerate innovative clinical and translational research to make the HI the world leader in improving outcomes for pediatric cardiovascular disease and disease risk". The Mission of HIRC is "HIRC supports innovative clinical and translational science by facilitating the design of research processes, the implementation of research plans, the dissemination and application of findings and the development of research professionals". The goals for HIRC include: •Increase productivity of high quality innovative research. •Develop national and international reputation for the Heart Institute. •Facilitate research that will ultimately improve patient outcomes and experiences. •HIRC will become increasingly self supporting over time. •Develop a clearly defined research process that supports the education, development and productivity of HIRC professionals. •Develop guidelines, approved by Heart Institute research leadership, to equitably allocate resources. •Design and implement a dynamic infrastructure, including the identification of current and future space needs that facilitates the achievement of research and scholarly goals. •Facilitate collaboration among specialties within the HI, as well as across the medical center and pediatric community worldwide. •Develop the personnel both within HIRC and the HI who will provide teaching and education support for translational and clinical research. Clinical Data Specialist Purpose of Position: In collaboration with the Director of the Heart Institute Research Core (HIRC), the Senior Data Manager will provide the following: oversight of all activities related to data management, contributions to the analysis, development, design, implementation, and maintenance of data management systems, consultation and direction related to information systems for HIRC management and staff in support of organizational and clinical study projects. Major Duties and Responsibilities: •In collaboration with the Director of HIRC, assume data management responsibility for HIRC. •Oversee and contribute to the analysis, development, design, implementation, and maintenance of clinical database structures. •Support the development of Case Report Form (CRF) Completion Guidelines in accordance with protocol specifications. Coordinate their review and approval to ensure accurate recording of assessment results and clinical study activities. •Oversee the development of a Data Management Plan (DMP) for individual projects and maintenance of appropriate documentation (study summary/data flow diagrams, timelines, critical variables list, data definition file, etc.) to ensure successful performance. Obtain approval for DMPs from the pertinent principal investigators (PIs) and statisticians. Provide timely and ongoing management of study data by reviewing DMPs and chairing review meetings. •Monitor DMPs via standard reports and customized metrics. Provide reports within and outside the project teams. •Act as the primary data management contact for all project teams. Train assigned employees on project-related data management procedures and guidelines. •Properly communicate standards in order to ensure that timelines are met according to objectives and goals, data reporting needs are scheduled and addressed, and the quality of data management deliverables is monitored. •Identify inconsistencies and errors in the CRF data and ensure their resolution. •Provide regular delivery of database output to facilitate routine reviews by pertinent investigators and HIRC management staff to aid in the evaluation of study progress, subject safety, and site activity management. •Provide oversight of initiation, cleaning, and closing/locking of clinical databases. •Ensure compliance with regulatory agencies, the Good Clinical Practice and Code of Federal Regulations guidelines, standard operating procedures, and standards of research practice. Support, interpret, and enforce CCHMC policies by ensuring all data are collected, stored, and analyzed in compliance with applicable organizational, local, federal, and international regulations and policies. •Work closely with the Clinical Research Manager and project managers to develop timelines and review budgets. •Serve as a key resource to research staff and collaborators in the resolution of complex problems involving study database structures, statistical analysis, data input and data export.

Platform:

Required Skills:

Education/Work Experience: Required: •Bachelor’s degree in related field, e.g. mathematics, statistics or science. •5 years related experience managing large data sets. •5 years of clinical research experience. Preferred: •Master’s degree in related field

Desired Skills:

Duration:
Start Date:
Location:	Cincinnati, OH
Travel:
Rate:	$53,643.20 - $89,419.20

Information about the company

Company Name:	Cincinnati Children's Hospital Medical Center
Contact Person:	Erin Lutz
Contact E-Mail Address:	erin.lutz@cchmc.org
Company Web Site:	www.cincinnatichildrens.org
Phone Number #1:	513-636-5679
Phone Number #2:
Fax Number:	513-636-5643

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