The CTRI provides investigators with Clinical Research Management Systems to support clinical research studies including clinical trials, biospecimen repositories, and observational studies. These software systems provide for secure capture and management of clinical study data, management of study/visit schedules, and management of budgets and associated financial data.
Incumbent will serve as a Clinical Research Database Specialist for eResearch Velos, a comprehensive, enterprise-wide data base program offered by the CTRI, that tracks clinical trial activities from start-up to close-out of the trial. Duties include coordinating with clinical trials/clinical research staff; reviewing consent and study protocols to determine study requirements; entering the study into Velos; creating study calendars, coverage analysis and milestones; and assisting with training users and creating training materials. Schedule meetings with investigators and staff, follow-up with users, and serve as point of contact for issue resolution. Work directly with the Velos Managers and CTRI IT operations team to assure the integrity of collected data and the satisfaction of users.
Must be able to work occasional overtime if needed.
- Experience in the clinical research domain, particularly in clinical trials, either as a clinical trials coordinator or clinical trials data manager.
- Knowledge of clinical trial regulatory requirements, including informed consent, adverse event reporting, renewals, etc. in order to comply with University and federal and state requirements.
- Experience with the Velos application or other clinical trial management system. Proven experience managing databases and monitoring and auditing information/data in order to ensure data integrity.
- Proven ability to understand, analyze, and interpret complex information, situations, and problems to define issues accurately and formulate logical conclusions from a broad range of situations, data, and observations.
- Proven proficiency with PC computer applications such as relational databases, spreadsheets, word processors, presentation software such as PowerPoint, electronic calendars, email and web-browsers in a network environment.
- Demonstrated ability to develop and deliver effective training materials, presentations, and manuals for internal and external to the department/office.
- Possess excellent communication skills both written and verbally to a diverse population. Ability to communicate effectively with both individuals and groups.
- Demonstrated customer service/interpersonal skills, including mature judgment, diplomacy, tact and patience. Experience in providing excellent customer service via phone call and e-mail correspondence.