Clinical Research Associate

Responsibilities:

• Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within the company.
• Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, and electronic or binder preparation for distribution
• Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review
• Prepare CST meeting minutes
• Act as a resource for the clinical sites and research monitors for the trial
• Assist with training of site staff who are working on the study
• Collect regulatory documentation and ensure accuracy
• Record the receipt of all key study documentation and contact site regarding missing records
• Review various study-related tracking systems to determine and report the status of clinical trial documents
• Collect outstanding documents by contacting the clinical trial sites or working with the field monitors
• Send notifications to the clinical trial sites regarding their IRB renewal dates
• Maintain and audit all study-related files in compliance with department standard operating procedures
• Assist with the follow-up and resolution of noted observations on audit and monitoring reports
• Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories
• Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies
• Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, and Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings
• Review and approve Site Qualification Reports for new clinical trial sites
• Train users on the EDC/case report forms and other systems that may be used (i.e., electronic regulatory Binders)
• Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement
• Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment

Qualifications:

• 1-2 years of clinical research experience with a bachelor’s degree and/or
• 4 years of clinical research experience with professional certification (CCRP, ACRP)
• Experience with communicating with hospital administrators, research nurses, and study coordinators
• Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements
• Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions