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City of Hope · 4 weeks ago

Research Data & Report Analyst - Clinical Trials Reporting

United States

Full-time

Remote

Mid Level

$35/hr - $55/hr

3+ years exp

City of Hope is a leading research institute focused on innovative approaches to combat life-threatening illnesses. The Research Data and Report Analyst will support the NCI Clinical Trials Reporting Program by ensuring data integrity, managing submissions to NCI CTRP and ClinicalTrials.gov, and collaborating with various stakeholders to enhance clinical research applications.

AssociationEducationHealth Care

Comp. & Benefits

Responsibilities

Develop and implement policies and procedures to support the quality of data in the OnCore CTMS

Assist in the quality control of required clinical research FDA reporting for COH studies

Responsible for leading quality control of data between OnCore and the external research systems (CTRP and ClinicalTrials.gov) for COH investigator initiated studies

Monitoring Quality Assurance (QA) of data within the OnCore system and will perform routine QA checks and analysis via various OnCore reporting tools

Closely monitor data integrity of the OnCore system and overall functionality

May assist with writing training manuals

May write training manuals, FAQs, newsletters or other similar documents for dissemination to end users

Assists OnCore administrator with other appropriate tasks as needed

Develop, maintain, and be responsible for the submission process of NCI supported interventional clinical trial accruals s to NCI CTRP

Develop, maintain, and be responsible for the submission process of investigator initiated interventional clinical trials for posting on the NIH ClinicalTrials.gov website as per federal regulations

Update submission SOPs to reflect the latest changes in submission requirements and regulations for NCI CTRP and ClinicalTrials.gov website

Collaborate with the Data Quality Manager of Analytics & Decision Support to develop reports and notifications to support NCI CTRP accrual reporting management and NIH ClinicalTrials.gov submission workflows

Maintain access provisioning for NCI CTRP and NIH ClinicalTrials.gov websites for City of Hope staff

Provide subject matter expertise regarding NCI CTRP accrual reporting and 42 CFR 11 (Final Rule) and NIH ClinicalTrials.gov regulations and requirements, including training of staff for timely and accurate submissions

Provides system configuration, design, and testing for Epic and OnCore as requested

Responsible for development of sub-systems within projects

Designs, develops, and documents programs assigned by project manager

Assists in establishing system testing requirements and in conducting overall system testing

Coordinates implementation of system and coordinates testing of system components

Provides support to end-users for various applications

Responds to calls from users requiring information on system performance and use, defining enhancements, and resolving problems

Attends meetings with users to discuss related systems. Provides follow-up in relation to progress of requests and resolution of problems

Qualification

Data Quality ManagementClinical Trials ReportingOnCore CTMSSystem TestingDatabase ManagementResearch Operations SoftwareCCRP CertificationACRP CertificationGrant Management SystemsCollaboration