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 meetingsResponsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminationsEnsure the clinical research project team(s) for a specific trial understands the project objectives, timelines, and tasksEnsure research project enrollment goals are met according to project timelinesDevelop or review study specific site budgets, providing constructive feedback as neededReview confidentiality disclosure agreements and clinical trial agreementsMonitor and contain site expensesReview study budget and line item payments against predicted accrualEnsure clinical research, physician office and facility staff are prepared for on-site visits by CRO or sponsorMaintain a state of audit-readinessManage a site level quality review programServe as a resource for clinical research staff by maintaining up to date knowledge of medical terminology and Good Clinical PracticeProvide resource planning for office and facility-related researchSupport clinical research staff as needed to ensure research subject safety and quality of dataOversee use of Clinical Trials Management SystemEnsure research-related regulatory approvals are obtainedLiaise with sponsors, CROs, practice members and Frenova Renal Research staffAttend investigators meetings as necessaryMaintain a positive and productive working relationship with physicians and staffProvide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee mattersReceive assignments in the form of objectives and determine how to use resources to meet schedules and goalsFollow processes and operational policies in selecting methods and techniques for obtaining solutionsInterpret and recommend changes to operational policies as needed, and establish procedures that positively affect Frenova Renal Research’s provided servicesParticipate and present at meetings with internal and external representatives as needed, often leading a cooperative effort among members of a project teamInteract with internal departments and external customers, particularly in problem resolutionAct as an advisor to subordinate(s) to meet schedules and/or resolve technical problemsProvide technical guidance as neededAssist with various projects as assignedOther 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 experienceAdvanced degree desirableClinical research certification required

EXPERIENCE AND REQUIRED SKILLS:

Minimum of 5 years of clinic research experienceMinimum of 3 years supervisory experience, project/program management experience or direct management preferred, preferably at the site or CRO levelExperience in conducting, managing, monitoring, and/or analyzing clinical research projectsExperience using a Clinical Trials Management System preferredDemonstrated knowledge of Good Clinical Practice and ICH, as well as OSHA standards and other site specific regulationsExcellent communication skills (interpersonal, verbal, written), attention to detail, organizational and prioritizing skills, and time management skills requiredStrong 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.

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.