Clinical Research Associate BioControl Medical
THIS JOB HAS EXPIRED Job Description
The Clinical Research Associate provides a vital link between investigative site and sponsor team. This on-site position includes a variety of tasks supporting successful execution of the clinical study and ensuring that the conduct of the trial is in compliance with the currently approved protocol, with GCP, and with applicable regulatory requirements.
Serve as a primary in house company representative in communication with assigned investigational sites
Maintain and track all relevant documentation and communication as part of the study file
Partner with investigational site personnel through center activation process and maintenance of IRB/EC renewals as needed
Review data, create queries and work with sites to close out queries in the database
Verify that source data/documents and other trial records are accurate, complete, and maintained in-house
Maintain positive working relationships with internal and external customers
Review and verify content and compliance of clinical trial agreements and patient informed consents
Assist in database testing and validation as needed
Ensure adverse events and protocol deviations are reported in accordance with the protocol as well as sites? IRB requirements
Adhere and assist with clinical operations and project specific quality documents (for example: SOPs, work instructions, training guides)
Perform other job related duties as assigned
Open and clear communication
Confident and influential approach
Ability to manage multiple priorities
Make independent choices and take responsibility for own actions
Understand the needs of others
Coordination and planning
Recognizes potential obstacles and work to resolve them within set timelines
Conscientious and precise delivery of work even when under pressure
Ability to perform independently and in a cross-functional team environment
Proficient computer skills (MS Office products, word processing, spreadsheets, etc.)
Presents professional manner and appearance
Knowledge of FDA regulatory requirements is required. Has knowledge of commonly-used concepts, practices and procedures within the medical device field.
At least 2-3 years clinical research experience in clinical/scientific research, nursing, or medical device / pharmaceutical industry required.
BS in the health/life sciences or study management preferred
General office environment, and includes up to 20% travel, as needed.
New Hope, Minnesota, USA
||New Hope, MN |
THIS JOB HAS EXPIRED