Intermediate Clinical Research Systems Analyst

Job Responsibilities

• 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.
• Performs data analyses, generates reports and other outputs based on the data maintained in the databases.
• Aids 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. Evaluates system solutions to operational issues with clinical research application vendors and to meet end user needs.
• Evaluates and documents business needs and prioritizes product enhancements and requirements to vendor product support.
• Collaborates with clinical research end users, vendor technical support, clinical research application owner, key stakeholders and research administration.
• Works 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.
• Develops and documents business requirements with end users to enhance operational efficiency.
• Aids in the development and maintenance of the knowledge base and data entry practices to ensure best practice.
• Identifies requirements and develops reports to meet organizational reporting needs.
• Identifies new software and modules that may enhance end user satisfaction.
• Leads data quality efforts and implements metrics for all clinical research applications and presents to research administration.
• Develops test plans as needed for any software upgrades and implementation.
• Works with research applications owner and vendors on change request process.
• Manages all testing efforts.
• Acts 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.
• Assigns tasks to CTMS team that are in their range of responsibility as needed in projects, requests, etc.
• Manages 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.
• Performs other duties as required.

Requirements

• 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.