Clinical Research Data Coordinator 1 - PM Biorepository

The Clinical Research Data Coordinator I manages the data for assigned research studies. This will include, designing forms for data collection, clinical data abstraction, reconciling data, maintaining record systems, and producing project reports for studies. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. 

While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the data coordinator plays a critical role in the study by reviewing, extracting, cleaning, and auditing data from various source documents so that the appropriate data can be shared.

Essential Functions 

• Collects and records study data from various source documents into different case report systems. 
• Inputs all information accurately into database 
• Maintains source documents and subject files in accordance with hospital procedures. 
• Reviews and audits database on a regular basis to ensure accuracy of data. 
• Makes corrections and additions to database records as required. 
• Ensures accurate and complete compilation of subject data through chart reviews.

Education

• Associate’s Degree Related Field

Work Experience

• One (1) years of related experience 
• An equivalent combination of education/certification and realized competencies may be considered.

Technical Knowledge, Skills, and Abilities 

• Intermediate knowledge of spreadsheets (such as Excel), familiarity with databases (ex: RedCAP, iMedra, Medidata, Velos, etc.) and ability to work with large volumes of data with a high degree of accuracy. 
• Proficient technical skills including Microsoft Office Exceptional attention to detail and accuracy 
• Meticulous and able to deliver reliable and high-quality product in a dynamic, fast paced environment 
• Demonstrate strong organizational skills; ability to manage multiple tasks & priorities.
• Strong interpersonal skills are required for working with the study participants and working as a member of a highly integrated multi-disciplinary team 
• Ability to foster smooth communications and teamwork among clinical research faculty, fellows, and staff as well as external sites and organizations (sponsors and contract research organizations). 
• Excellent oral and written communication skills with the ability to present to groups. 
• Knowledge of applicable local and federal regulations and ability to follow strict guidelines.