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.
In addition to a meaningful cause and professional work environment, we offer excellent benefits (medical, dental, vision, 403B with match, gym membership) and promote work-life balance. For more information, please visit: www.curesearch.org.
We are currently seeking a RESEARCH COORDINATOR (aka Clinical Data Manager) for our Phase I Consortium. The 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, and the clinical, laboratory, and resource center staff responsible for performing COG studies. The position will be an RC I or RC II, depending on experience.
RESPONSIBILITIES AND DUTIES:
The responsibilities of the Research Coordinator II include, but are not limited to:
1. Typically maintain a greater study volume than a RC I for both studies in development and studies which are ongoing.
2. Participate in presentations/discussions regarding a disease area of interest for the CRA discipline committee at COG annual Group meetings.
3. Must be fully proficient with all RC related applications (i.e. Study Manager, SDE, RDMS, BRV, etc.)
4. Expected to work with minimal supervision for the majority of their routine responsibilities.
And the all RC I responsibilities and duties listed below:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Organize, coordinate, or monitor surgery, chemotherapy, pathology, radiology, and radiation therapy reviews, and accumulate the data from these reviews as determined by the protocol.
9. Work with IT staff to address technical problems or system enhancements affecting data systems.
POSITION REQUIREMENTS:
• Bachelor’s degree or higher in a science-related field or equivalent relevant experience.
• Certification as a Clinical Data Manager (CDM). CCDM or other reputable industry certification for clinical data management.
• Minimum two to three 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.
• Experience as a CRA/CDM in a comprehensive cancer center, cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
• 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.
• Critical thinking and reasoning.
- Location: Arcadia, CA
- Compensation: $50K-$55K / DOE
- This is at a non-profit organization.
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.