CureSearch National Childhood Cancer Foundation is dedicated to raising private funds for childhood cancer research for the Children's Oncology Group (COG), the world's largest cooperative cancer research organization. Together, we are committed to conquering childhood cancer through scientific discovery and compassionate care.The COG is a network of more than 5,000 physicians, nurses, and scientists whose collaboration, research and care have turned childhood cancer from a virtually incurable disease to one with an overall 78% cure rate.
We are currently recruiting for a Clinical Data Manager (CDM; aka Sr. Research Coordinator) position.He/she will serve as the lead research coordinator for a specific disease area.This entails ultimate responsibility for the management of all aspects of study coordination and data acquisition of studies within a specific disease area.The CDM will work closely with the Research Coordinators assigned to studies in their disease area in the creation of CRFs, CRF reviews, study committee conference calls, SDE rules, data monitoring, etc.
RESPONSIBILITIES include:
•Management of all aspects of data collection within a specific disease area.
•Participate in presentations/discussions regarding a disease area of interest at COG annual Group meetings.
•Review sections of study protocols related to patient treatment, supportive care, specimen submission, patient follow-up, and any other sections requiring understanding of clinical or laboratory aspects of COG studies.
•In collaboration with the study statistician and study committee, design the draft Case Report Forms (CRFs) and data validations required to collect the necessary research data for COG studies.
•Create new group data elements (GDEs) as needed to capture essential research data for the study, or identify required GDEs from the existing GDE database, following established guidelines and procedures.
•Based on finalized CRFs, implement data elements and data validations for the Enhanced Remote Data Entry System (eRDES) through the Study Manager application. Complete testing, refinement, documentation and release of these screens adhering strictly to the established development procedures.
•Manage the conduct of studies including, but not limited to, monitoring patient enrollments and randomizations and closing or suspending studies as determined by protocol design or Study Chair to ensure patient safety.Create and execute the Study Data Review Plan according to established procedures.
For full job description, please see the Jobs section of our website:www.curesearch.org.
REQUIREMENTS:
•Bachelor’s degree or higher in a science-related field or equivalent relevant experience.
•Certification as a Clinical Data Manager, CCDM or other reputable industry certification for clinical data management is required.
•Minimum two years experience as a CRA, CDM or equivalent combination of experience and education credits, or must be a Level I RC for at least 2 years.
•Experience as a CRA/CDM in a comprehensive cancer center or cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
•Must have excellent knowledge of disease area.
•Must be fully proficient with all RC-related applications (i.e. Study Manager, SDE RDMS, RDMSSE, BRV, etc.).
•High level of basic scripting (SQL) and familiarity with data reporting tools desirable.
•High level of PC literacy is required, including intermediate to advanced knowledge of Microsoft Office software such as MS Word, Excel and Access.
•Excellent written and oral communication skills are essential.
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It is NOT ok to contact this poster with commercial interests.
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