Job ID 210000WR
Available Openings 1
PURPOSE AND SCOPE:
The Supervisor of Clinical Research is responsible for supervising the execution of RRI's clinical research projects to ensure project timelines and execution goals are met, and all clinical research activities receive applicable corporate and local level approvals and appropriate Institutional Review Board (IRB) approval. Will also ensure that RRI's clinical research projects are conducted, recorded and reported in compliance with, as applicable, The Office for Human Research Protections (OHRP), The Office of the Inspector General (OIG), Good Clinical Practice (GCP) and The International Conference of Harmonization (ICH) guidelines as well as RRI's Standard Operating Procedures (SOP). This position exercises a high level of independent initiative, with direct responsibility for results.PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
- Supervises/directs daily operations of subordinates to complete assignments using established guidelines, procedures and policies. Provides immediate supervision of a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. A portion of time is normally spent performing individual tasks related to the unit or sub-unit.
- Ensures that clinical research projects are executed within specified timelines and budgetary constraints, and in accordance with the Fresenius Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Establishes and maintains effective internal systems and controls to promote safety and compliance.
- Provides direct supervision of assigned team(s) through ongoing leadership and guidance.
- Assists with coaching and counseling employees
- Provides subordinates with developmental feedback during the year as well as formal feedback through the annual performance evaluation process
- Works collaboratively with all members of the RRI Research and Operations teams.
- Participates in planning, implementing and supervising the execution of multiple concurrent clinical research projects.
- Performs data collection, analysis and interpretation of research findings
- Is accountable for the quality and integrity of the research undertaken.
- Abstract and manuscript preparation.
- Presentation of research findings at internal and external meetings, including national and international scientific conferences.
- Facilitates the development of study documentation, such as case report forms, informed consent forms, clinical study reports (progress reports), and clinical portion of regulatory submissions (e.g., study participant demographics, study participant complaints, adverse events).
- Contributes subject matter expertise towards development of study protocols and study budgets.
- Supports the initiation of new lines of clinical research.
- Manages the clinical research equipment and supplies
- Participates in the preparation of Standard Operating Procedures (SOP), guidelines, and quality improvement projects
- Assists the immediate Supervisor with personnel decisions with respect to hiring, disciplining, and terminating where necessary
- Orientation and training of new clinical research personnel in established study procedures
- Other duties as assigned
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, personal computer and laboratory work. The position requires travel to internal and external meetings and to various study site locations as required. 10-15% travel is required for this position (domestic and international).
- Responsible for the direct supervision of RRI junior and senior clinical research staff (e.g., Clinical Research Coordinators, Research Scientists) as well as research support staff (e.g. Research Interns).
EDUCATION AND REQUIRED CREDENTIALS:
- MD or equivalent degree is essential for this position
- 7 – 10 years' related experience; or a Master's degree with 6 years' experience; or an MD degree with 3 years' experience; or equivalent directly related work experience.
- Minimum of 3 years of clinical research experience, preferably in kidney disease and dialysis
- Must be fluent in the English language, with excellent communication skills - verbal and written
- Basic familiarity with statistical data analysis techniques and statistical software (R, SPSS, Systat, SAS, GraphPad Prism; R preferred)
- Prior publications in peer-reviewed scientific journals
- Excellent presentation skills and ability to accurately present results and ideas to large audiences of senior level management, peers and colleagues
- Computer skills: proficient in MS Excel, MS PowerPoint and MS Word
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.
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