Responsibilities The Clinical Research Manager is directly responsible for the operations management of the Research Program (clinical research initiatives and bio repository initiatives) and for the oversight of the day-to-day management of the research staff at each respective clinic conducting research. The Clinical Research Manager is the primary contact for sponsors, Norton Healthcare departments, and for physicians.
Key Accountabilities:
- Oversee external audits, oversee implementation of quality improvement initiatives, address quality issues, participate in Standard Operating Procedure (SOP) development and maintenance, maintain the Operations Manual, and address monitoring issues as appropriate.
- Work with sponsor(s) to plan and oversee the implementation of trials/projects. Define scope of project and develop project plan. Set scope boundaries/ timelines and deliverable schedule. Work with Medical Director, Director, and Physicians to determine if trial/project is feasible for program.
- Serve as primary contact for external customers (i.e. pharmaceutical companies), NHORA, and research investigators; support the Research Medical Director and/or administrative director in the coordination and leadership of Research meetings as assigned; develop and maintain relationships with Medical Science Liaison's (MSLs); represent research with NHORA to ensure on-time study start-up, successful study close-out, study financial accountability, etc.; represent research in meetings and committees as assigned.
- Program management of research operations, financial responsibility of both studies and operations; oversee employee engagement action plans, performance appraisals, hiring/ firing, corrective actions, lead staff meetings; participate in the annual budget process; liaison with nurse managers and directors of clinics conducting research as appropriate. Direct assigned projects, manage changes to project plan, renegotiate timelines as necessary. Monitor project progress. Maintain team accountability during project execution. Manage timelines, objectives and expectations of program and executive leadership as it relates to the project. Foster team participation. Lead and supervise project team through collaborative project planning process. Schedule and/or attend meetings with leadership as necessary to facilitate updates and communication (i.e. PI monthly meetings). Communicate to Principal Investigators monthly study reports (and associated meetings).
Qualifications Required:
- Three years clinical research or evidence based research
- One year leadership or management in a healthcare setting
- Bachelor Degree
- One of: CCRA or CCRC or CCRP - Must obtain Certified Clinical Research Associate (CCRA) or Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) credential within 3 years of hire.
Desired:
- Master Degree
- Certified Clinical Research Associate OR Certified Clinical Research Coordinator OR Certified Clinical Research Professional