SUMMARY
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 responsibility for upholding U.S. Renal Care's research practices and policies.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties and tasks may be assigned.
- Manages the operational and logistical tasks of clinical research to ensure efficient execution of trials within establish 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).
- 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 execution.
- 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. Maintain productive and effective current physician research relationships.
- 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 trial participation.
- Assists with the maintenance of the Clinical Trials Management System including but not limited to oversight of the patient stipend payments process.
- Assists 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 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 aspects.
- 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 our USRC research investigator physicians and practices. Conducts 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 assist 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 teameffort.
- Effectively communicates expectations; accepts accountability and holds others accountable for performance.
- Regular and reliable attendance is required for the job.