Job Details

Job Description: Pay Range: $95000year - $115000year Responsibilities: Manages the operational and logistical tasks of clinical research to ensure efficient execution of trials within established budgets and timelines and ensure all activities are in compliance with the appropriate regulations. Good Clinical Practice (GCP), Food and Drug Administration (FDA) Federal Code of Regulations, all applicable state and local agencies). ssists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, patient recruitment and trial plan execution. Maintains productive and effective current physician research relationships. Collaborates with applicable internal teams to deliver efficient clinical research integration into facilities and a seamless transition for new nephrology practices interested in clinical trial participation. ssists with the maintenance and use of the Clinical Trials Management System. ssists field coordinators with all aspects of sponsor relations (on-site visits such as site initiations and written requests for information) as needed. Develops and maintains professional relationships with industry partners, contract research organization (CROs), research investigator physicians and clinical and business operations divisions. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Positively represents USRC at sponsor investigator meetings, national conferences and in the field environment (clinical research sites). Collaborates with the Director of Clinical Research and Director of Quality, Clinical Research to ensure quality metrics are upheld by our research investigator physicians and practices. Conducts internal site GCP audits to ensure program requirements are achieved. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. Recruits, trains, develops, and supervises clinical research department personnel as well as assists with training and on-boarding of new research investigator physicians. Ensures appropriate licensures and certifications are in place. Maintains effective personnel management and employee relations, including evaluating the performance of CRC personnel; approving and submitting all hours worked and counseling and disciplining employees. Upholds management goals of corporation by leading staff in team concepts and promoting a team effort. Effectively communicates expectations; accepts accountability and holds others accountable for performance. Regular and reliable attendance is required for the job. Qualification: Three plus years of experience in clinical research preferred. four year college degree is preferred. n equivalent combination of work experience and education will be considered in lieu of a degree. Clinical Research Coordinator Program (CCRP) Certification or eligibility for the same or similar required. Nephrology experience preferred. Knowledge of kidney care and/or End-Stage Renal Disease (ESRD) or similar field is a plus. Work experience within a dialysis organization or in direct patient care is a plus. Extensive knowledge of FDA regulations, IRB requirements and Good Clinical Practice. Excellent interpersonal and communication skills, both verbally and in writing. Proficient computer skills, including Microsoft Office (Word, Excel, PowerPoint, Outlook and web based tools) required.