The Clinical Trials Coordination Center (CTCC) specializes in the development, management, and conduct of clinical research studies. We convey new knowledge leading to the treatments and better understanding of diseases with the goal to improve the health or quality of life of patients and families.
We are seeking an experienced Clinical Research Associate (CRA) to add to our team. Requirements include:
Knowledge of planning, implementation, coordination, evaluation and reporting of clinical trials
Competence in electronic data capture
Strong verbal and written communication skills, interpersonal skills, attention to detail and organization required
Approximately 75% travel
To monitor site investigator compliance with clinical trial protocols according to applicable regulations
Interface with Project Manager/Team Leader, Project Team, clinical investigators and other study personnel
Conducts on-site and off-site monitoring activities to ensure investigative sites are complying with clinical trial protocols, FDA regulations, SOPs, ICH and GCP guidelines
Assists in study start-up processes, including identification and initiation of new sites, development of monitoring plan and tools, site staff training, acquisition of clinical supplies, regulatory compliance (e.g., IRB, FDA, GCP)
Prepares monitoring visit reports, as well as initial and follow-up communications to sites
The CTCC is a department within the University of Rochester. Along with traditional health and dental benefits, the University provides several wellness programs focused on work-life balance. Our position within the University also provides employees several opportunities for learning and growth.
About Clinical Trials Coordination Center at University of Rochester
The Clinical Trials Coordination Center (CTCC) fosters multi-center research through the development, management, and reporting of hypothesis-driven, controlled clinical trials.