We have an exciting opportunity to join our dynamic team in the Department of Medicine as Clinical Research Supervisor (CRS) Cellular Therapy Service .

As a CRS, you will supervise the day-to-day activities of the Clinical Research Associates (CRAs-protocol management) and the Clinical Research Coordinators (CRCs-data management) to ensure efficient and effective operations. You will be responsible for data management activities, data integrity, protocol and patient management associated with clinical research. Also, you will have the opportunity to participate in special projects and task forces as determined by management. You will manage several research protocols, including investigator-initiated trials, industry-sponsored studies, as well as bio-specimen protocols.

What will you do:

• Staff Management and Development - Participate in the interviewing, hiring, orientating, training and supervision of CRAs & CRCs; participate in facilitating departmental trainings; align staff resources with appropriate protocols and research needs; andmaintain workflow consistency among staff with standardized processes.
• Operation Management - Ensure that workflow is managed and monitored to meet departmental and service needs;assist the Clinical Research Manager (CRM) with protocol activation, especially with start-up activities; monitorresearch portfolio for workload by appropriately managing and identifying service needs.
• Quality Assurance - Perform regular audits to ensure that the data collected is complete and accurate, and that theresearch project is carried out as planned.
• Regulatory Compliance - Ensure that all appropriate Institutional, State, and Federal regulations are followedthroughout the course of a research project, database, or protocol. Ensure that research protocols are approved bythe Institutional Review Board/Privacy Board (IRB/PB) and followed as written.
• Data collection - Utilize appropriate methodologies to collect patient/human subject information for research projects,databases, and/or protocols.
• Data reporting - Generate reports to all necessary parties. Prepare data for analysis, monitoring visits and audits.
• Clinical Research Billing Management - Implement Principal Investigator's decisions regarding Patient-Care Costs.
• Special Projects - Participate or coordinate on both interdepartmental and intra-departmental organization-wideresearch projects as requested. You will provide leadership, organizational, creative, or clerical support to establishedand new research initiatives.

Who are you:

• Bachelor's degree with at least 3 years of clinical research experience OR a high school diploma with 6 years of clinicalresearch experience
• Supervisory experience and experience with high volume trials is strongly preferred.
• Comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21
• CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability andAccountability Act (HIPAA) is critical.
• Strong time management/project management skills.
• Knowledge of oncology-specific terminology is helpful.
• Experience in the use of various electronic data management systems. Strong Data management skills, includingdatabase design preferred.
• Basic knowledge of Microsoft suite (PowerPoint, Word, Access, Excel) and Teamshare.
• Effective at building formal and informal networks inside and outside the organization to further departmental andinstitutional goals.
• Adept at building partnerships and working collaboratively with others to meet shared objectives and goals.
• A good decision-maker, with shown success at making timely decisions that keep the organization moving forward.
• Eager to foster talent and support people in meeting their career goals and the organization's goals.

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