Clinical Data Manager

The Research Coordinator (RC) is responsible for managing all aspects of study coordination and data acquisition for a group of COG studies. This entails coordination of data collection from institutional investigators, laboratory researchers and study committee members as well as preparation of ad-hoc reports as needed.  The RC of a COG study will be the primary contact for that study between the Data Center and COG institutional participants in the study, members of the study committee, the Statistics Department, the Study Development Office (SDO), other COG administrative offices, the Information Technology (IT) Department, the clinical, laboratory, and resource center staff responsible for performing COG studies.

 

Primary Responsibilities

 

The responsibilities of the Research Coordinator include, but are not limited to:

? 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 data screens (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 draft data screens, 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. 

? Monitor the quality of submitted research data through the eRDES reporting module to evaluate timeliness of institutional data submissions and the completeness and internal consistency of data.  When necessary, modify or enhance data validations to prevent and correct data errors and omissions that have been identified.

? Set up and monitor systems for rapid tracking and reporting of dose-limiting toxicities, toxic deaths, severe adverse events (SAEs), treatment failures, or other critical study endpoints, as appropriate for the study.

? Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.

? Work with IT staff to address technical problems or system enhancements affecting data systems.

? Conduct remote data audits of COG member institutions and laboratories. 

? Author or revise, as directed by the Lead Research Coordinator, standard operating procedures (SOPs) related to the function of research coordinator in COG.

? Serve as on-call after hours research coordinator according to the established schedule (typically 1 week duration once every 2 months, but subject to change).  This involves carrying a cell phone/laptop computer, being on call 24 hours a day, for any problems that may arise that affects treatment assignment of a patient.

 

Minimal Position Requirements

 

Bachelor?s degree or higher in a science related field or equivalent relevant experience;  certification as a Clinical Research Associate (CRA) with at least two years experience as a CRA or equivalent combination of experience and education credits.  Direct experience as a CRA in a comprehensive cancer center or cooperative group is desirable.  Excellent written and oral communications skills are essential.  High level of PC literacy is required, including intermediate to advanced knowledge of Microsoft Word and Access including basic scripting and familiarity with data reporting tools.