The Clinical Operations Manager - GI will manage clinical research activities led by investigator(s) and faculty in the Cancer Center research program. This position is a working manager role and will also be responsible for conducting study activities including consenting, follow up visits, etc. Will assist in the development and implementation of departmental standard operating procedures. Responsible for planning and executing operational aspects of research within the department, including managing deliverable, timelines, oversight of project costs, contracts, and agreements. Assists in grant writing, budget creation, and submission of grant requests to federal and foundation agencies. Responsible for leading cross-functional teams all in support of achieving the Cancer Center’s mission.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Starting salary will be between the minimum and midpoint of the range listed for this position.
We offer a comprehensive benefits package: Health, dental, vision (effective day 1), employer paid life, LTD, flexible benefits plan, miscellaneous voluntary plans available, paid vacation and sick (begin accruing upon hire), paid holidays, paid discretionary day, paid bereavement leave, paid jury duty, military leave, paid parental leave, retirement plan. For more information, go to: Benefits (kumc.edu)
In addition to the above, The KUCC reimburses our staff for maintaining their Socra certification. We also pay for one professional organization membership dues.
Required Qualifications:
- Education: Associate’s degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals 8 years.
- Work Experience: Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA). Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research. In-depth knowledge of study budgets, contracts and grant applications.
- Skills: Research certification required such as Socra, Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP). Demonstrated ability to work independently with moderate direct supervision. Excellent communication skills; oral and written. Demonstrated ability to multitask. Expert computer skills; medical terminology; investigative scientific methods.
Preferred Qualifications:
- Education: Masters or higher degree in life sciences or healthcare field.
- Skills: Experience working with cross functional teams in managing projects. Demonstrated ability to manage several project teams and competing priorities simultaneously.
Job Duties Outlined:
- Manage and serve as primary contact for assigned clinical trial activities. Develop, understand and manage contractual and organizational expectations; nurture internal and external stakeholder relationships and needs. Primary contact for all protocol clarifications and logistical project related concerns.
- This is a working manager position so will be responsible for conducting study activities including consenting, follow up visits, etc.
- Assign, review, and train individual staff and multiple study teams. Employ escalation and performance plans as needed. Serve as expert mentor to junior staff. Establish and assign the activities of multiple teams to accomplish study goals. Provide constructive feedback to team members.
- Develop direct reports through initial on-board training, regular 1:1 mentoring and coaching, career path management, leave requests, continuing education and delegation of responsibility.
- Communicate effectively laterally across the team as well as up and down reporting structures within the Clinical Trials Office (CTO).
- Mentor team members to prioritize, solve problems, and plan contingencies. Delegate activities while retaining ownership. Communicate project findings and priorities. Liaise with senior leadership to optimize performance of project team members.
- Assure employees in area of responsibility comply with all KUMC, regulatory and other appropriate policies and approved practices.
- Provide oversight and training to team members who are responsible for recruitment, obtaining informed consent, performing protocol required study procedures, maintaining essential documentation.
- Coordinate and communicate with sponsor, CRO, and ancillary research departments and organizations involved in the day- to- day study and program management.
- Track progress of projects and create progress reports. Prepare research reports for research personnel and funding organizations. Ensure the data collection and research protocols follow all sponsor and institution protocols.
- Evaluates clinical research matrix, including data management query resolution timelines and non-compliance reports for the development of Corrective and Preventive Action and departmental processes.
- Participate in internal and external research audits and inspections.
- Manage project deliverables by monitoring metrics. Prepare, assist, and lead presentations of internal project status to senior leadership, disease working groups, and other stakeholders as needed. Be accountable for follow-up on action items. Take the initiative in identifying, resolving, or escalating issues.
- Review and assist with editing of new protocols. Assess feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study.
- Aid in study budgetary preparation and resource planning needs to accomplish study objectives.
- Monitor observance of departmental operational policies and guidelines.
- Perform other duties as assigned.
Required Documents:
- Must provide both: Cover Letter & Resume/CV
