Manager, Clinical Research

U.S. Renal Care

3h•Onsite

About The Position

The Manager of Clinical Research reports to the Director of Clinical Research and is responsible for assisting with 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. This role involves managing the operational and logistical tasks of clinical research to ensure efficient execution of trials within established budgets and timelines, and ensuring all activities comply with appropriate regulations (Good Clinical Practice (GCP), Food and Drug Administration (FDA) Federal Code of Regulations, all applicable state and local agencies). The manager assists in coordinating efforts of internal and external resources (industry partners, clinical research organizations) for efficient trial selection, patient recruitment, and trial plan execution. They maintain productive and effective current physician research relationships, collaborate with applicable internal teams to deliver efficient clinical research integration into USRC facilities, and facilitate a seamless transition for new nephrology practices interested in clinical trial participation. The role also includes assisting with the maintenance and use of the Clinical Trials Management System, supporting field coordinators with all aspects of sponsor relations (on-site visits such as site initiations and written requests for information) as needed. The manager develops and maintains professional relationships with industry partners, contract research organizations (CROs), research investigator physicians, and USRC clinical and business operations divisions. A key aspect is fostering a patient-care culture that emphasizes patient safety and quality in all aspects. The manager positively represents USRC at sponsor investigator meetings, national conferences, and in the field environment (clinical research sites). They collaborate with the Director of Clinical Research and Director of Quality, Clinical Research to ensure quality metrics are upheld by USRC research investigator physicians and practices, and conduct internal site GCP audits to ensure program requirements are achieved. The manager maintains a working knowledge of current clinical research practice standards and regulatory requirements. This position is responsible for recruiting, training, developing, and supervising clinical research department personnel, as well as assisting with training and onboarding new research investigator physicians, ensuring appropriate licensures and certifications are in place. Effective personnel management and employee relations, including evaluating the performance of CRC personnel, approving and submitting all hours worked, and counseling and disciplining employees, are also essential. The manager upholds management goals of the 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.

Requirements

Clinical Research Coordinator Program (CCRP) Certification or eligibility for the same or similar required.
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; proficiency in USRC applications required within 90 days of hire.

Nice To Haves

Three (3) plus years of experience in clinical research.
A four year college degree.
Nephrology experience.
Knowledge of kidney care and/or End-Stage Renal Disease (ESRD) or similar field.
Work experience within a dialysis organization or in direct patient care.

Responsibilities

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.
Maintains 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 and use of the Clinical Trials Management System.
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 the Director of Clinical Research and Director of Quality, Clinical Research to ensure quality metrics are upheld by our USRC 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 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 team effort.
Effectively communicates expectations; accepts accountability and holds others accountable for performance.
Regular and reliable attendance is required for the job.