Manager, Clinical Trials

• Responsible for appropriate staffing and skills to adequately administer the CTO core functions.
• Supervise the training/development and performance management for Research Study Assistants, Research Project Coordinators, and Clinical Research Coordinators (direct and indirect reports). Responsible for the hiring of new staff.
• Develop and implement strategies to continuously improve employee engagement.
• Collaborate closely with the Associate Director for Clinical Investigations, chair(s) of the protocol review and monitoring systems (PRMS), and committee(s) to assure the ultimate success of clinical research programs.
• Keep abreast of current state-of-the-art developments relating to clinical trials and provide education to clinical staff and other team members.
• Participate in conferences, scientific meetings, and writing of abstracts.

• Provide operational leadership and effective management for the GW Cancer Center Clinical Trials Office (CTO), including community–based partners, consortia members, and outreach clinics.
• Responsible for coordinating all aspects of clinical research operations at the Cancer Center to ensure that high-quality and ethical clinical research is conducted within an environment that facilitates clinical research and that will enhance the scientific reputation of the Cancer Center both nationally and internationally
• Manage the expansion of clinical research activities to satellite sites and affiliates
• Oversee the structure and processes of the PRMS, including Scientific review and DSMP functions
• Assure compliance with the GCP, human subjects’ protection, and all regulatory agencies
• Build the appropriate infrastructure to support clinical trial-related activities.

• Develop, implement, and update SOPs to ensure consistent, safe, and efficient management of clinical trials and the subjects enrolled.
• Provide oversight over clinical research informatics matters related to CTO operations and clinical research conduct in collaboration with the relevant Cancer Center and institutional managers.
• Ensure quality, timely, accurate data submission. Develop quality control mechanisms and systems for the management of data.
• Generate protocol status reports for key stakeholders including Principal Investigators, leadership, clinical teams, institutional review board, etc. Provide oversight for monthly reports about accrual, monitoring, and audit visits. Provide oversight and guidance for monthly reports of income from industry-sponsored trials as well as grants. Accountable for accuracy of trial information in all trial databases and tracking systems.
• Lead QA functions for the clinical research operations; participate in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trials, etc.
• Actively work to address quality improvement opportunities.
• Incorporate a patient-centered approach that consciously includes the patient and family’s perspective and focuses on needs as they define them.

• Demonstrated comprehensive skills and training in clinical research and business administration, including financial management, personnel administration, program planning, development, and implementation, are desired.
• Working knowledge of FDA regulations governing clinical research, Good Clinical Practice, and OHRP regulations is a plus.
• Previous supervisory experience is preferred.
• Excellent interpersonal and verbal/written communication skills.
• RN or MS/MPH preferred, with two years of management and three years of oncology clinical research experience desired.
• Ability to utilize clinical research databases and learn/train is a plus.
• Previous experience coordinating and managing oncology clinical research programs, especially in an academic medical center setting, is preferred.
• Proficiency in Excel and PowerPoint is a plus.

How is pay for new employees determined at GW?