Job Search
Research Data & Report Analyst - Clinical Trials Reporting
Job Details
- Job Ref:
- 10032546
- Location:
- United States (This is a remote job)
- Category:
- Clinical Research
- Job Type:
- Full-time
- Shift:
- Days
- Pay Rate:
- $35.68 - $55.31 per hour
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
A Research Data and Report Analyst position is available to support the NCI Clinical Trials Reporting Program at the National Medical Center of City of Hope. You will collaborate with all levels of staff to support end-user and institutional reporting needs across clinical research applications and Enterprise Data Warehouse. You will develop, implement, and maintain the process for entering summary level accrual information in OnCore and manage the data integrity across multiple clinical research systems. Additionally, you will be responsible for the submission of all NCI supported interventional trial accruals to the National Cancer Institute Clinical Trials Reporting Program (NCI CTRP) and ClinicalTrials.gov website. You will also participate user requirement analysis, process development, clinical research system testing, policy and procedure development, training and support to system users as summarized below.
Your Duties and Responsibilities will include:
Clinical Research System Data Quality
· In partnership with the senior leadership team, 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
Submission to NCI CTRP and NIH ClinicalTrials.gov
· 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
System and Business Analysis
· In collaboration with the City of Hope Senior leadership teams and stakeholders, 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
Qualifications
Your qualifications should include:
· Bachelors degree in life sciences, information technology, business administration or related fields. Bachelors degree or higher is preferred.
· 3 years of experience in systems and database management
· Experience with sponsored research management / research operations software systems
· CCRP or ACRP certificate is preferred but not required
· Prior experience within grant management systems is preferred
· Experience within sponsored research, academic or research environment is preferred.
City of Hope is an equal opportunity employer.
To learn more about our Comprehensive Benefits, please CLICK HERE.