- Department: Clinical and Translational Science Institute (CTSI)
- Schedule: Full-Time Regular
- Shift: Day shift
- Hours: 8:30- 5:00
- Location: Tufts Medical Center
Tufts Medical Center is an internationally-respected academic medical center and a principal teaching hospital for Tufts University School of Medicine. We conduct groundbreaking medical and health policy research and are in the top 15 percent of independent institutions receiving federal research funding. As a not-for-profit organization, Tufts Medical Center is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Our mission of advancing knowledge and training students to become future investigators drives forward with one goal in mind - quickly turning innovative research into pioneering care.
Tufts Clinical and Translational Science Institute (CTSI) (www.tuftsctsi.org), one of 64 organizations supported by the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSAs), was established in 2008 to transform the biomedical research process through education, collaboration and the provision of infrastructure services. Tufts CTSI accelerates the translation of laboratory research into clinical use, medical practice, and health policy.
Tufts Medical Center (Tufts MC) and Tufts CTSI are seeking a talented Research Analyst to join the Clinical Trials Management System (CTMS) implementation team, participate in requirements gathering, process analysis, system configuration and interfacing, application management, and user support after Go Live. This is a great opportunity for an individual with clinical trial coordinator/research administration experience, who is interested in exploring the intersection of technology, research administration, and clinical trial operations.
Working closely with Tufts MC project manager, the project implementation team and research administration, the Research Analyst will have the following responsibilities:
Play a key role in the design, build and deployment of a CTMS at Tufts MC.
Analyze, create, and update business processes to include best practices and performance metrics.
Lead business requirement gathering sessions for the development of CTMS including, but not limited to; data collection, data transfers, template setup, reporting, data integration, system integration, quality control and data management.
Actively participate in development of internal Standard Operating Procedures and necessary end-user training materials related to CTMS.
Manage day-to-day administration of CTMS application, and maintain appropriate system user access, roles, and security based on company policies and industry best practices.
Meet regularly with system stakeholders to assess and modify (as applicable) clinical systems.
Assist in configuring and testing system upgrades, support enhancements, perform change control, and system validation.
Schedule and perform system reviews/audits, troubleshooting/root cause analysis, report findings to department leadership, and work with appropriate stakeholders to resolve findings.
Mentor and assist in the training of end-users on core CTMS functionalities and processes.
Provide ongoing support to study teams, including, but not limited to: gathering requirements, administrative set-up of new protocols, calendar building, budget and other data entry, and creating study specific reports.
Work with study teams to identify and administer study specific projects within clinical systems; oversee Tufts CTSI Clinical Research Network and CTSA Consortium multi-site trial administration in CTMS.
Develop, run, and distribute scheduled and ad-hoc reports for stakeholders, including study teams, department leadership, and Tufts MC and CTSI leadership.
Maintain in-house web pages for CTMS functionality.
Champion the adoption of core CTMS modules. Inform and train end users on new functionality.
Perform other duties as assigned.
Prior experience in a healthcare environment of clinical research setting.
Experience working in or with clinical trials, clinical research. Management and administration, and/or IRBs, clinical trial invoicing/financials preferred.
Knowledge of data standards best practices in research and healthcare, scientific, and medical concepts and terminology.
Demonstrated knowledge of confidential HIPAA policies as they relate to clinical research and electronic databases.
Strong analytical skills and knowledge in documentation and reporting, with the ability to design and execute tests, analyze system performance data, and produce substantive reports and analyses.
Ability to work with senior staff and managers, serving as a technical resource and providing advice and counsel on issues of functionality, efficiency, cost-effectiveness, policy, and performance.
Strong problem-resolution skills, with the ability to quickly diagnose problems, and develop, test, and implement appropriate and effective solutions in a timely manner.
Strong interpersonal skills, with the ability to effectively, train, support, and work collaboratively with users of clinical information systems at all professional and technical levels.
Detail oriented, with proven organizational skills and the ability to effectively manage time, prioritize tasks, and see projects through to completion on deadline.
Strong written and verbal communications skills, with the ability to convey technical information and instructions to all levels of clinical applications users in a specific, clear, and concise manner.
Excellent customer responsiveness in all end-user interaction.
Bachelor's degree in health care, information technology, computer science, or scientific related area, and / or an equivalent combination of experience / training ;
4+ years in biopharmaceutical research & development or in a CRO.
2+ years of experience with maintaining or working with a CTMS.
Knowledge of 21 CFR Part 11 validation, HIPAA, CDISC, medical terminology.
Knowledge of study design criteria and data collection strategies.
Experience working with electronic research tools such as CTMS, eCRF, electronic proposal submissions systems.
Knowledge of coverage analysis, medical billing terms and research billing operations for industry-sponsored and federally sponsored studies.
An equivalent combination of education and experience which provides proficiency in the areas of responsibility listed above may be substituted for the above education and experience requirements.