Assistant Director, Clinical Research Operations
Hyde Park Campus
About the Unit
The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.
The Assistant Director assists the Director of Clinical Research Operations in establishing standards and best practices for data management and data quality within the Section. This position will be responsible for ensuring Section-wide compliance with regards to our local Institutional Review Board (IRB), National Cancer Institute (NCI) guidelines, Good Clinical Practice (GCP) and FDA Regulations.
Responsible for recruitment, placement, and management of the research data managers assigned to industry sponsored, cooperative group and investigator initiated trials (IIT). Facilitate and provide quality assurance oversight to the research staff. Responsible for working with staff to ensure data completion is timely and accurate.
Responsible for developing and implementing new staff orientation materials for data managers and data quality personnel. Serves as a resource to principal investigators (PIs) and Section leadership on data management/data quality needs, feasibility assessments, compliance, and best practices. Develops and manages reports on key data. Ensures timeliness of data and reporting submissions from multiple investigators; establishes and implements consistent standards and protocols. Ensures ongoing competence of data managers and data quality personnel within the section, with both direct and indirect lines of reporting authority. Liaises with Section leadership, Research Managers, faculty, University Research Administration (URA), Office of Clinical Research (OCR), Institutional Review Board (IRB), and other key constituents throughout the University and network as needed.
- Supervise, support and train data management staff within the Section; ensure contractual obligations regarding data entry are met.
- Align staff based on disease programs, workload, sponsor databases, and/or therapeutic drugs
- Liaise with Research Managers to review and manage trial priorities from a data management perspective and provide data management input into timelines.
- Manage and/or participate in on-site monitoring visits and/or audits, including but not limited to, ensuring site readiness, organize PI and other internal meetings; determine compliance status and identify compliance risks.
- Ensure monitoring visits, audits and inspections are executed successfully; assists with management of monitor and sponsor relationships.
- Meet with monitors while on site and ensure disease programs complete outstanding items in follow up letters.
- Organize staff to allow time to meet with monitors in an effort to reduce queries.
- Work with Clinical Trials Financial Group (CTFG) to ensure data management needs are budgeted correctly.
- Manage the monitoring room calendar and track the Monitoring Fee invoices for completed visits.
- Develop a data quality program for Investigator Initiated and Cooperative Group Trials.
- Work with PIs to develop Case Report Forms (CRFs) for IIT Trials.
- Develop a process for data reporting to PIs on IIT trials.
- Develop streamlined process for data collection on Section-wide biobanks.
- Develop key quality metrics across disease programs and determine appropriate actions in conjunction with management.
- Ensure data reporting and results reported to clinicaltrials.gov.
- Works with Section, department, and divisional leadership on strategic initiatives.
- Collaborates with other institutional offices on initiatives related to clinical research conduct and operations.
Education Experience and Certifications:
- Bachelor's degree required.
- Master's degree preferred.
- Research certification (e.g., Graham School, SoCRA, ACRP) preferred.
- Seven years of clinical research experience or research experience combined with relevant experience required.
- Three years of staff management and/or supervisory skills required.
- Experience managing research projects required.
- Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, creation of monitoring plans) preferred.
- Experience in a complex and demanding leadership role preferred.
- Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application.
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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