We are seeking a Clinical Research Supervisor (CRS) to join our dynamic team Gastrointestinal Oncology Service in the Department of Medicine . As a CRS, you will supervise the day-to-day activities of 8-12 Clinical Research Coordinators (CRCs) to ensure efficient and effective operations. You will be responsible for data management activities and for data integrity 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 initiative trials, industry-sponsored studies, as well as bio-specimen protocols. In the GI Service, we have more than a dozen subspecialists, each focused on a single malignancy of the GI tract, including esophageal, gastric, pancreatic, liver, and colon cancer. Our faculty regularly treat rare diseases such as carcinoid neuroendocrine tumors and tumors of the gallbladder. New drug development programs, treatment approaches for cancers of unknown origin, and our intrahepatic chemotherapy program are all part of the teams broad palette of expertise. You will: - Staff Management and Development - Participate in the orientation, training and supervision of CRCs; participate in facilitating departmental trainings; align staff and resources with appropriate protocols and research needs; and maintain workflow consistency amongstaff 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; monitor research 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 the research project is carried out as planned.
- Regulatory Compliance - Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Also, you will ensure that research protocols are approved by the 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 (institutional and federal) on the progress. You will prepare data for analysis, monitoring visits and audits.
- Clinical Research Billing Management - Implement Principal Investigator's decisions regarding Patient-Care Costs (both billable and non-billable), and ensures that research non-billable services are not billed to patients/human subjects or insurers. Also, you will assist manager with billing reconciliation.
- Special Projects - Participate or coordinate on both interdepartmental and intra-departmental organization-wide research projects as requested. You will provide leadership, organizational, creative, or clerical support to established and new research initiatives.
You Are: - Effective at building formal and informal networks inside and outside the organization to further departmental and institutional 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.
You Have: - A bachelor's degree with at least 3 years of clinical research experience OR a high school diploma with 6 years of clinical research 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 and Accountability 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, including database design preferred.
- Basic knowledge of Microsoft suite (PowerPoint, Word, Access, Excel) and Teamshare.
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