Intermediate Clinical Research Systems Analyst

Position Title:                   Analyst (Intermediate)-Clinical Research Application Systems

Creation/update Date:      May 28, 2025 

Position Code:                 

Department:                      Baptist Clinical Research Institute

Job Summary: This position works within the Baptist Clinical Research Institute (BCRI) and is overall, responsible for all Clinical Trial Management System (CTMS) and clinical trial applications (e-Regulatory, REDCap, EPIC/Research, EHR-to-EDC applications), and coordinates all technical aspects of the development, implementation, maintenance, and evaluation of the vendor applications supporting clinical research. Accountable for building and executing test plans, upgrades, escalations from the vendor application teams, problem investigation and resolution, end user support, drafting summary reports, discussing potential workflow improvements or solutions, evaluating procedures, etc. This position interfaces with internal and external IT teams supporting implementation, upgrades, customizations, and end user support; works extensively with clinical trial budget specialists, clinical research coordinators, and clinical research administration to build study budgets, study calendars, reconcile study visits, create invoices in accordance with the study protocols and be responsible for ongoing support of same. This position will also be responsible for supporting clinical research applications for BCRI users through all phases of training, implementation, optimization, and maintenance. Works with internal and external teams and end users to achieve application integration to meet clinical research and business needs. Exercise discretion and judgment in the performance of original, creative, intellectual work. Will be working with BCRI leaders for developing and optimizing BCRI's portfolio of clinical trials and clinical research projects to maximize revenue flow. This position requires strong analytical and communication skills. 

The job responsibilities are: 

• Work closely with Clinical Research Nurses/Coordinators, Clinical Research Data Managers, Clinical Research Management Team, and Budgets and Contracts Specialists in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, and institutional policies and procedures and departmental SOPs to provide on-going support for entering clinical research information into clinical research applications, developing and maintaining accurate databases for clinical research studies.

• Designs clinical trial and financial calendars in the CTMS (VELOS) system and ensures proper documentation is attached including coverage analyses and negotiated budgets.
• Perform data analyses, generate reports and other outputs based on the data maintained in the databases;
• Assists in the development and maintenance of standard operating procedures.
• Suggests changes and additions to database methodology and data capture process to data management team.
• Primary contact for the research application vendors. 
• Evaluate system solutions to operational issues with clinical research application vendors and to meet end user needs. 
• Evaluate and document business needs and prioritize product enhancements and requirements to vendor product support. 
• Collaborate with clinical research end users, vendor technical support, clinical research application owner, key stakeholders and research administration. 
• Work closely with internal and vendor IT, interface owners, and research application owners to review and assess current functionality, interfaces, data usage and more, across all research applications to recommend improvements and additional automation. 
• Develop and document business requirements with end users to enhance operational efficiency. 
• Assist in the development and maintenance of the knowledge base and data entry practices to ensure best practice. 
• Identify requirements and develop reports to meet organizational reporting needs. 
• Identify new software and modules that may enhance end user satisfaction. 
• Lead data quality efforts and implement metrics for all clinical research applications and present to research administration.
• Develop test plans as needed for any software upgrades and implementation. 
• Work with research applications owner and vendors on change request process. 
• Manage all testing efforts. 
• Act as escalation point for issues and requests from end user community / research application project team; includes additional issue investigations needed for more complicated reporting requests. 
• Trains clinical research staff on e-research applications, how to incorporate and manage the e-research applications in the daily workflow. 
• Assignment of tasks to CTMS team that are in their range of responsibility as needed in projects, requests, etc. 
• Manage small to medium projects from inception through completion including developing, executing, and monitoring project and work plans. Determines customer needs and system solutions for meeting those needs. 
• Perform other duties as required.

Experience:

Minimum: 2 years of clinical research experience with a pharmaceutical company, at a clinical research site, contract research organization (CRO), or equivalent. Knowledge of medical terminology; previous experience in the healthcare setting. Must be self-directed, have a keen eye for detail, excellent communication, and organization skills.  Strong computer skills to include Microsoft Office Word, Excel, and PowerPoint. Excellent skills in English (both verbal and written) is required. 

Preferred: 4 years of clinical research experience with a pharmaceutical company, at a clinical research site, contract research organization (CRO), or equivalent. Must have an analytical approach to problem solving and needs definition.  Comfortable asking questions, working with minimal supervision, and collaborating with coworkers in a team environment on complex projects. Quick and agile learner, able to adapt to changes in technology and its intended use. Able to synthesize complex clinical trial information in order to facilitate decision making.