CTMS Program Analyst
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 Details
This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.
Overview
Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services – from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford’s care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation’s most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus. Learn more at henryford.com/careers.
Benefits
The health and overall well-being of our team members is our priority. That’s why we offer support in the various components of our team’s well-being: physical, emotional, social, financial and spiritual. Our Total Rewards program includes competitive health plan options, with three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. Our team members enjoy a number of additional benefits, ranging from dental and eye care coverage to tuition assistance, family forming benefits, discounts to dozens of businesses and more. Employees classified as contingent status are not eligible for benefits.
Equal Employment Opportunity/Affirmative Action Employer
Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health is
committed to the hiring, advancement and fair treatment of all individuals without regard to
race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height,
weight, marital status, family status, gender identity, sexual orientation, and genetic information,
or any other protected status in accordance with applicable federal and state laws.