Main Areas of Responsibility:
You will develop strategies and drive processes to meet the milestones of complex clinical studies in compliance with applicable clinical and regulatory standards and in alignment with NMHI business needs; create and develop standards and guidelines for all clinical research services and programs; and ensure adherence to standard operating procedures, good clinical practice and FDA rules and regulations.
Additional Areas of Responsibility:
This role will utilize a broad range of experience in study solicitation, regulatory preparation and submission of sponsor and government required documents, negotiating enforceable contract language in coordination with budget information ensuring a profitable outcome for NMHI; communicate regularly with NMHI Board of Directors to provide relevant study status information; and author necessary study tools and departmental SOP’s. Budgeting and financial management experience required.