Research Operations Manager - Medicine

Overview

Coordinates and/or manages all aspects of complex, multi-component research projects, general research and projects for the assigned service line. Manages activities related to regulatory compliance and staff training, project contracts, budgets, and all related research finances, workforce needs throughout the research group, maintenance of databases and coordination with the Office of Sponsored Projects for any state or federally funded studies. Provides oversight of any project that requires a filing with national boards or committees (i.e., Institutional Research Board (IRB)/ Committee for Protection of Human Subjects (CPHS), etc.), and assures compliance with the Food and Drug Administration (FDA), Good Clinical Practice (GCP) research standards, JCAHO and Internal Conference on Harmonization (ICH) guidelines as appropriate. Provides a forum for review and vetting of new protocols and the progress of existing protocols and monitors enrollment and finances of existing trials.

Responsibilities

Ensures quality and success of clinical research endeavors.

Leads the development of operational and strategic plans for the assigned organization’s research group in alignment with established research policy.

Supervises all assigned clinical research personnel either directly or via supervisory staff. Provides leadership in mentoring new and current clinical research staff, staff training in department research and administrative procedures, performance evaluation, and encouragement and support of personal and professional development.

Convenes regular research / advisory committee meetings where proposed protocols are presented to the group and decisions are made whether to accept or include a study based on business and scientific evidence.

Works with the Clinical Trials Office (CTO) and study Principal Investigators (PI) to develop, manage and monitor clinical trial contracts and budgets; monitors and submits patient care costs/reimbursements; assures that all contract compliance items are completed; and prepares and presents financial reporting to the research team & leadership as appropriate.

Organizes and manages clinical trials and other research studies/projects, including recruitment strategies, workflows, document creation and guidance, management tools, site visit tasks, and regulatory documentation maintenance and distribution in conjunction with PIs.

Provides leadership and direction to Fellows, Principal Investigators, and research staff in maintaining compliance with applicable state and federal regulations. Monitors adverse events and reports serious events to appropriate agencies, committees or boards as well as to sponsor(s) per study requirements.

Ensures proper workload distribution and back up support for each research team member and develops and encourages standardization of processes and procedures.

Serves as liaison with participating clinical centers throughout North America and with applicable agencies, committees, boards (i.e., IRB/CPHS, the NIH, and the FDA, etc.) with regard to adverse events, study initiations, study revisions, study enclosures, etc.

Coordinates investigator meetings or protocol specific training.

Prepares grants for funding department research.

Monitors clinical trials to allow for timely and accurate renewals and submissions.

Performs other duties as required or assigned.

Qualifications

• Bachelor’s degree with 5 years of relevant experience in a healthcare field related to the specific area of research, or the equivalent in education and experience required.
• Master’s degree preferred.
• Excellent organizational, writing, and office software skills required.
• Prior supervision experience preferred.

Required Licensure/Certifications

• Certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required, and/or obtained during the first two (2) years of employment.