[Hiring] Director, Clinical Research @U.S. Renal Care

Role Description

The Director of Clinical Research reports to the VP of Clinical Research and is responsible for oversight of the day-to-day operations of research physician/clinical site partners who conduct multiple FDA regulated clinical trials. Responsibility also includes management of Clinical Research Coordinators (CRC) and upholding U.S. Renal Care's research practices and policies.

• Manages the operational and logistical tasks of clinical research to ensure efficient execution of trials within established budgets and timelines.
• Ensures 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).
• Assists 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.
• Assists with the recruitment of new industry partners, research opportunities, and access to novel therapies.
• Promotes growth of USRC's research footprint by identifying and pursuing future nephrology research investigator physicians and practices in both the CKD and dialysis space.
• Maintains productive and effective current physician research collaborations.
• Collaborates with applicable internal teams to deliver efficient clinical research integration into USRC facilities and a seamless transition for new nephrology practices interested in clinical trials.
• Assists with the maintenance of the Clinical Trials Management System, including oversight of patient stipend payments.
• Assists field coordinators with all aspects of sponsor relations (on-site visits such as site initiations and written requests for information).
• Develops and maintains professional relationships with industry partners, contract research organizations (CROs), research investigator physicians, and USRC clinical and business operations divisions.
• Fosters a patient-care culture that emphasizes patient safety and quality in all activities.
• Positively represents USRC at sponsor investigator meetings, national conferences, and in the field environment (clinical research sites).
• Collaborates with VP of Clinical Research to develop a quality assurance program and ensure metrics are upheld by USRC research investigator physicians and practices.
• Conducts site GCP audits to ensure program requirements are met.
• 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 onboarding 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.
• Approves and submits all hours worked and counsels and disciplines staff as needed.
• Upholds management goals of the corporation by leading staff in team concepts and promoting teamwork.
• Effectively communicates expectations; accepts accountability and holds others accountable for performance.
• Regular and reliable attendance is required.

Qualifications

• Eight (8) plus years of experience in clinical research.
• A four-year college degree preferred. An equivalent combination of work experience and education will be considered in lieu of a degree.
• Clinical Research Coordinator Program (CCRP) Certification 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.
• Intermediate computer skills, including Microsoft Office (Word, Excel, PowerPoint, Outlook, and web-based tools) required; proficiency in USRC applications required within 90 days of hire.