Clinical Coordinating Center Project Manager

Department: RI Office of Clinical Trials Administration (OCTA) ----- Office of Clinical Trial Administration (OCTA) Position Title: Clinical Coordinating Center Project Manager Job Family Group: Professional Staff Job Description Summary: The Research Project Manager is responsible for project managing single and multi-center clinical trials supported by the Clinical Coordinating Center. This will include developing services and resources for project management, and assisting with regulatory submission and maintenance, safety monitoring for investigator-initiated trials and assisting 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. Will assist with service allocation, budget development and reporting for Clinical Coordinating Center clients. Will manage deliverables to multi-disciplinary teams and study sites; oversee the project management of study development, site selection, investigational product coordination and assist sites with data quality and safety management responsibilities of single and multi-site trials. Job Description: Develop and oversee the project management operations for single and multi-center investigator-initiated trials. Assist the coordination of Institutional Review Board materials and submissions and maintenance of the Trial Master File, includes tracking in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, and other study start-up requirements in partnership with study teams. Work with teams to develop clinical study documents, including protocols, SOP's, Manual of Study Operations, source documents, informed consent forms, case report forms, monitoring plans, training plans, and procedure manuals. Support and coordinate of the project funding and act as a liaison between the study team and funding source. This includes Assessing the feasibility of research protocol, including reviewing appropriate patient population, budget and specific needs for the study. Provide oversight and training to team members who are responsible for recruitment, obtaining informed consent, performing protocol required study procedures, maintaining essential documentation and needs to ensure the Clinical Trial meets or exceeds enrollment goals. Ensure that clinical studies are conducted per state and federal regulations, GCP guidelines, institutional requirements and KUMC policies. Coordinate activities of clinical sites and vendors involved in the project. Coordinate and communicate with sponsor, CRO, and ancillary research departments and organizations involved in the day-to-day study and program management. This includes coordinating communication among clinical trial team members, presides over staff meetings and strategies to ensure all studies have adequate staffing resources. Develop and execute communication and training plans for Investigators and trial sites involved in the study. Recommend agendas and provide leadership for the study Operations Committee and Steering Committee, Monitoring Board and other planning calls. Assist the sponsor investigator with establishing safety monitoring plans for multi-site trials and allocate resources for risk based monitoring services. 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. 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 reports related to data management query resolution timelines and non-compliance reports for the development of Corrective and Preventive Action and departmental processes. All other duties assigned by the supervisor. Required Qualifications: Education: Bachelor’s degree or equivalent experience in research, life sciences, or related field and 4 years work experience or equivalent combination of relevant post secondary education and work experience that equals 8 years. Work Experience: Experience in design, implementation or support of multi-site studies or investigator-initiated clinical trials. Skills: Strong task-delegation abilities, with demonstrated ability to organize and develop realistic plans while being sensitive to the needs of different constituencies, time constraints, and resource availability. Demonstrated project management skills with the ability to manage multiple high priority efforts or competing priorities and the flexibility to adjust to changing requirements, schedules, and priorities. Team leadership skills with strong interpersonal communication and writing skills. Working knowledge of FDA regulations, Good Clinical Practices (GCP) guidelines and Regulations applicable to study implementation and data management. Preferred Qualifications: Education: Master’s degree or equivalent experience in research, life sciences, or related field Comprehensive Benefits Package: Health coverage on day one, dental, vision, 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 leave, military leave, paid parental leave, retirement plan. Required Documents: Resume/CV Cover Letter Employee Type: Regular Time Type: Full time Rate Type: Salary Pay Range: $78,000.00 - $124,000.00 Minimum $78,000.00 Midpoint $101,000.00 Maximum $124,000.00 The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care. The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information. http://policy.ku.edu/IOA/nondiscrimination https://kumc-publicpoliciesandprocedures.policystat.com/policy/8446235/latest/ https://admin.ks.gov/offices/personnel-services/policy--programs/fmla https://www.kumc.edu/public-safety/clery-information/annual-security-report.html https://www.kumc.edu/documents/hr/EO-Statement.pdf https://www.laborposters.org/federal/1606-federal-pay-transparency-poster.htm

Salary : $78,000 - $124,000