Senior Clinical Research Coordinator bei None

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. 
• Manage, train and support clinical site staff.
• Review, comprehend and communicate study protocols.
• Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV). 
• Assist CRC team as requested to facilitate research and business needs.
• Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP’s.
• Ensure all data is entered into sponsor’s data portal and all queries are resolved in a timely manner. 
• Work closely with CRO/CRA and IRB.
• Perform administrative tasks such as ordering supplies and equipment for the study.
• Manage all required study start up documentation, training and timelines on assigned study protocols.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. 

EDUCATION AND EXPREIENCE: 

• Associate’s degree and/or completion of accredited healthcare certification program, required.
• Comfortable stepping into a leadership role. 
• 4+ years’ experience in Clinical Research and knowledge of protocols and procedures required.
• 4+ years’ experience working as a Clinical Research Coordinator, preferred.
• Comprehensive knowledge of FDA, GCP & confidentiality.
• Exceptional attention to detail and organization.
• Excellent written and communication skills.
• A proven ability to multi-task in a rapidly changing environment.