What are the responsibilities and job description for the CTMS Program Analyst position at Henry Ford Health System?
Responsible for serving as the first line of technical support for the Health System's Clinical Trials Management Systems (CTMS) electronic systems, including Advarra's OnCore and eRegulatory, as well as related interfaces with additional systems, and future systems deployment; assist with system setup, build, activation and ongoing support of all trial types, including federally funded, industry-sponsored, and investigator initiated human subject research; work directly with research departments and provide reporting and auditing of each system to ensure Henry Ford Health minimum data requirements in OnCore and eRegulatory are being achieved; provides support with system implementation, creating user accounts, coordinating calendars, budget build requests, and research department calendar queries; serve as a key member of the OnCore support team; support operations and coordination of research departments within the Advarra systems, subscription utilization, and regulatory compliance; utilize technical analytical skills to seek out, research and evaluate a variety of solutions to provide research personnel with high quality, efficient workflows and data that promotes efficiency and enterprise-wide standardization; utilize clinical trial workflow knowledge to recommend the best design and implementation of CTMS procedures and protocols; interact with internal contacts including the PI, research assistants, and research coordinators regularly; provides workflow suggestions and maintain CTMS system build requests; interact with external contacts including sponsor monitors and auditors that may need access to a CTMS platform or assistance accessing the system; support system-wide centralized research reporting of growth and compliance metrics through performance of monthly regulatory and documentation audits for assigned research departments; perform quality assurance audits of monthly subject visit reporting documentation supporting optimization of research financial performance; track aging invoices and facilitate timely receivables through collaboration with the department and Fund Accounting; perform maintenance, incident resolution, and testing activities for CTMS systems; support critical enhancements issues in multiple IT systems; utilize and apply knowledge of clinical trial coordination, database support activities, Microsoft Office Suite, SQL, process improvement initiatives, OnCore, operating systems/networking standards, GCP/FDA/ICH regulations, protocol reviews, DMPs, User Acceptance Testing (UAT), and clinical data management to perform assigned duties; serve as a gatekeeper to the CTMS systems production environment, ensuring consistency in policies and operational procedures, release integration testing, and production validation.
Location : 1 Ford Place, Detroit, Michigan, 48202.
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Education: Bachelor's Degree in Health Informatics, Data Science, Healthcare Administration, or in a related field of study (will accept equivalent foreign degree);
Experience: One (1) year in the position above, as a Clinical Data Scientist, as a Clinical Study Coordinator, as a Data Associate, as a Clinical Pharmacist/Clinical Data Associate, as a Research Assistant, or in a related occupation;
Other Requirements: Experience must include use one (1) year of all the following: clinical trial coordination, database support activities, Microsoft Office Suite, SQL, process improvement initiatives, GCP/FDA/ICH regulations, protocol reviews, DMPs, User Acceptance Testing (UAT), OnCore, and clinical data management.
Will also accept any suitable combination of education, training, and/or experience.
Additional Information- Organization: Henry Ford Medical Group
- Department: Clinical Trials Office Strateg
- Shift: Day Job
- Union Code: Not Applicable
