$100K — $150K *
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Oncology Clinical Research Unit [OncCRU]
Responsible for the oversight of research and day-to-day operations including finances and personnel management for the Brain Tumor Center Clinical Research Program of the Duke Cancer Institute [DCI]. Collaborate closely with DCI Leadership, Finance and Human Resources, Duke Office of Clinical Research [DOCR], School of Medicine [SOM], Principal Investigators [PIs] and departments throughout the institution to carry out these responsibilities effectively.
Oversee study conduct including study initiation, IRB submissions and renewals, protocol initiation, participant recruitment, screening, consent and enrollment, data collection, safety reporting, study monitoring and audits, study closeout, and record retention and storage. Assist with the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
Monitor the status of timelines and milestones for research studies to ensure timeliness, performance in accordance with all institutional standards, and compliance with Good Clinical Practice standards, Duke Policies and procedures, SOPs, and applicable regulatory requirements. Provide updates and reports to leadership as required.
Conduct quality assurance audits. Oversee and participate in internal and external audits. Review and implement audit reports; develop and implement corrective actions plans in response to identified problems.
Oversee compliance with institutional requirements pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance. Connect study teams with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB) to ensure data quality. Ensure Quality Assurance processes are in place and followed.
Responsible for the implementation, adoption, and monitoring of new research technologies or systems and data capture requirements (e.g. Oncore, Maestro Care, eReg, Advarra EDC etc.).
Collaborate on writing and implementing contracts and agreements.
Collaborate and work closely with the DCI Finance Team and assigned research programs on the feasibility of new studies including staffing requirements, clinical and logistical considerations, drafting budgets, and budget negotiation and payment terms, maximizing revenue, effort reporting and closing out studies.
Review financial reports to identify and implement solutions to budget-related issues. Bring in DCI leadership, PIs, research staff and others for discussions and solutions.
Manage and approve monthly staff effort in collaboration with the finance team.
Responsible for requesting and managing clinical research system access for staff.
Continuously identify methods to improve CRU and institutional procedures and policies. Base decisions on data analysis collected via clinical research management systems.
Develop strategies to ensure implementation of institutional SOPs, policies, and initiatives.
Oversee the writing, implementation and maintenance of standard operating procedures [SOP] within the DCI CRU. Ensure staff are trained and knowledgeable in SOPs.
Oversee orientation and ongoing training for staff on your teams. Oversee the documentation of staff’s requited training and certifications. Ensure staff identified by the e-IRB system as responsible for a given protocol qualify for the role and maintain their qualification.
Conduct and lead meetings for leadership, teams, and staff to ensure good communication, including goals. Effectively communicate new policies, regulatory updates, and institutional SOP changes.
Valid through: 2/2/2022
$150K — $200K *
38 days ago
$80K — $100K *
9 days ago