Academic Research Coordinator
TriHealth · Cincinnati, OH · 1 wk ago
AnalystFull-time
Job Responsibilities
- Develops processes to facilitate implementation of the research protocol to provide effective and safe medical research to all subjects.
- Demonstrates the ability to identify potential and/or actual issues which may prohibit the accurate implementation of the research protocol and initiate interventions to avoid protocol violations and /or unsafe practice.
- Ensures compliance with IRB/FDA standards and deadlines in the following: notification of subject randomization and enrollment, completing Progress Reports, reporting all deaths and adverse events with study subjects, and facilitating communication between study sponsor and designated TriHealth IRB.
- Affirms potential subjects for inclusion and exclusion criteria.
- Keeps Case Report Forms complete and thorough using the IRB and FDA standards.
- Supports hospital staff in complying with research protocols and works to minimize the impact on their workload.
- Keeps queries and protocol violations that can be controlled to a minimum. Responds appropriately and accurately to all queries in a timely fashion.
- Maintains accurate and detailed follow up schedules to assure meeting regulatory time points.
- Maintains study data and performs analysis; assists with study presentation materials and developing posters for presentation and / or manuscript for publication.
- Potentially works with the IACUC and process for CME application.
- Performs initial and ongoing evaluations of research subjects and implements care directed towards optimal outcomes.
- Plans care for research subjects/family based on clinical consultation, standards of care, optimal outcomes and protocol requirements.
- Implements and evaluates plan of care.
- Performs technical skills according to policy and procedure and accepted TriHealth standards.
- Documents in medical records appropriately.
Job Requirements
- Bachelor's Degree in Science (Required)
- 2 - 3 years’ experience Professional Healthcare (Required)
- Microsoft Office Basic Life Support (BLS) Upon Hire Required