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PURPOSE AND SCOPE:

Provides support to Frenova Renal Research and the contract research organization (CRO) by monitoring and tracking the progress of clinical study activity at research sites. Provides support with regulatory agency and sponsor inspections/audits as needed.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Manage clinical research staff including but not limited to: interviewing potential new staff, training of new and existing staff, staff coverage, and team meetings

• Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations

• Ensure the clinical research project team(s) for a specific trial understands the project objectives, timelines, and tasks

• Ensure research project enrollment goals are met according to project timelines

• Develop or review study specific site budgets, providing constructive feedback as needed

• Review confidentiality disclosure agreements and clinical trial agreements

• Monitor and contain site expenses

• Review study budget and line item payments against predicted accrual

• Ensure clinical research, physician office and facility staff are prepared for on-site visits by CRO or sponsor

• Maintain a state of audit-readiness

• Manage a site level quality review program

• Serve as a resource for clinical research staff by maintaining up to date knowledge of medical terminology and Good Clinical Practice

• Provide resource planning for office and facility-related research

• Support clinical research staff as needed to ensure research subject safety and quality of data

• Oversee use of Clinical Trials Management System

• Ensure research-related regulatory approvals are obtained

• Liaise with sponsors, CROs, practice members and Frenova Renal Research staff

• Attend investigators meetings as necessary

• Maintain a positive and productive working relationship with physicians and staff

• Provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters

• Receive assignments in the form of objectives and determine how to use resources to meet schedules and goals

• Follow processes and operational policies in selecting methods and techniques for obtaining solutions

• Interpret and recommend changes to operational policies as needed, and establish procedures that positively affect Frenova Renal Research’s provided services

• Participate and present at meetings with internal and external representatives as needed, often leading a cooperative effort among members of a project team

• Interact with internal departments and external customers, particularly in problem resolution

• Act as an advisor to subordinate(s) to meet schedules and/or resolve technical problems

• Provide technical guidance as needed

• Assist with various projects as assigned

• Other duties as assigned

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Day to day work includes desk and personal computer work and interaction with study sponsors, physician-investigators, field CRAs, vendors, patients and office/facility staff.

• The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. This position requires physical effort. Employee must be able to lift and carry up to 30 pounds. This position does involve direct contact with patients and includes performing phlebotomy procedures, as needed. Occupational Health and Safety Risks include potential exposure to blood borne and airborne pathogens.

• The position requires occasional travel to investigator meetings, physician offices and regional and corporate meetings, up to 25% of the time. The position requires travel between assigned offices/facilities and various locations within the community.

SUPERVISION:

• Responsible for the direct supervision of various levels of clinical research staff, potentially in multiple locations

EDUCATION:

• Bachelor’s degree in Nursing or Health Sciences, or equivalent experience

• Advanced degree desirable

• Clinical research certification required

EXPERIENCE AND REQUIRED SKILLS:

• Minimum of 5 years of clinic research experience

• Minimum of 3 years supervisory experience, project/program management experience or direct management preferred, preferably at the site or CRO level

• Experience in conducting, managing, monitoring, and/or analyzing clinical research projects

• Experience using a Clinical Trials Management System preferred

• Demonstrated knowledge of Good Clinical Practice and ICH, as well as OSHA standards and other site specific regulations

• Excellent communication skills (interpersonal, verbal, written), attention to detail, organizational and prioritizing skills, and time management skills required

• Strong computer skills required

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.