University of Rochester Clinical Research Assoc (S) in Rochester, New York
Full Time 40 hours Grade 053 Medicine M&D-Cardiol; Hrt Res
8:30 AM-5 PM
Coordinates study activities for multiple site international clinical trials and core laboratories for FDA-regulated clinical trials, assists Manager in training of Federal regulations, policies, and industry practices related to sponsored studies to meet IND and IDE FDA compliance standards with considerable latitude for the exercise of independent judgment and initiative in support of clinical research conducted under strict FDA regulations.
- Coordinates the activities of enrolling center staff at member institutions and core laboratories as they relate to clinical/study responsibilities including training, data collection, operations, and communication with travel to institutions as necessary.
- Ensures compliance with applicable regulatory requirements and IRB standards. Ensures integrity of all study data collected. Ensures protocol activities are administered consistently across study sites according to internal standard operations procedures and work instructions.
- Develops and writes operational procedures for data quality control and data form construction with specific attention to clinical variables and continuity including internal study-specific work instructions.
- Assists with development of recruitment strategies, information and database systems, training invoicing, forms, reporting and study tracking (timeline systems) per contractual requirements.
- Other duties as assigned.
Bachelor’s degree and 3-5 years of experience in industry sponsored clinical research coordination or an equivalent combination of education and experience with ability to effectively prioritize and execute tasks in deadline driven environment. Cardiology, clinical training and/or regulated clinical trial experience helpful with strong organizational and communication skills. Strong comfort level and proficiency with personal computer systems and clinical trial web applications strongly preferred.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Clinical Research Assoc (S)
Location: School of Medicine & Dentistry
Job ID: 208924
Full/Part Time: Full-Time