The Clinical Support Services Associate (CSSA) will assist the Director of Clinical Support Services with the following services: Safety Management [Data Safety Monitoring Board (DSMB) / Clinical Events Committee (CEC)], Client Training, Internal Training, Consulting, Site Support, and other administrative support as needed.
Safety Management: Coordinate administrative and operational aspects of the CEC, DSMB, and medical monitoring activities, including occasional evening meetings. Work closely with study teams and board/committee members to establish time frames for safety management committee reviews. Develop regular reports for clients on safety management activities and payments (Sunshine Act), as requested. Adhere to the quality system and compliance procedures as it relates to the safety management activities.
Client Training: Assist in organizing and providing client training programs for clinical research professionals, including development of training materials and records and coordinating details (schedules, format, etc.). Assist in the maintenance and development of IMARC University content and managing client accounts.
Internal Training: Assist with supporting new employee orientation and on-going staff training to ensure compliance with current global clinical research trial regulations and sponsor requirements as well as continual staff development.
Consulting: Assist in maintaining project records as needed such as for development of quality system procedures and training programs for research professionals.
Site Support: Assist in providing remote support to research sites, including data review and entry in EDC systems and maintaining project records.
Salary commensurate with experience.
This position requires travel approximately 10-25% of the time.
If you're interested in a career with IMARC, please send your resume to email@example.com.