Onc Res Ld Data&Audit Coor III
3 weeks ago
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to its employees by providing competitive rates and compensation, a comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description:
Oncology and Research are specialized and require unique skill sets. Realigning the MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston’s recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients to advance care. The data and auditing demands of managing the study portfolio requires a lead position in order to oversee data operations and train new staff members.
Research:
1.1 Oversees data and auditing operations for MD Anderson Cancer Center at Cooper University Health Care.
1.2 Manages the cooperative group/federally funded studies including training and review of trials.
1.3 Audit preps for NRG specific audits- chart review and preparation.
1.4 Completes and maintains the relevant research training to function in the role- including EPIC training, EPIC billing, CITI, GCP, and Specimen Handling.
Manages and completes long-term data.
Monitor subjects per protocol requirements and ensure adherence to protocol.
1.7 Organize and maintain all documentation required by the sponsor or CRO per GCP – includes source documentation (including the electronic medical record system, EPIC), case report forms, and research charts.
1.8 Collect, review and report timely, valid, accurate study data. Obtain records required to complete case report forms. Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 10 days of issuance. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.
Participates in groups within the department- SOP, RRC, etc.
1.10 Acts as a mentor for the oncology research department at MD Anderson Cancer Center at Cooper University Health Care
Supervisory/Management:
2.1 Participates in the management of the departmental data management activities.
2.2. Supervises Oncology Research Clinical Assistants
2.3 Completes Supervisory skills series offered by Cooper.
2.4 Works with the Director of Oncology Research Operations to assign protocols to staff and monitors compliance of research assistant staff to standards, policies and quality measures.
2.5 Coordinates and participates in the interview and selection process.
Supervisory/Management:
2.1 Participates in the management of the departmental data management activities.
2.2. Supervises Oncology Research Clinical Assistants
2.3 Completes Supervisory skills series offered by Cooper.
2.4 Works with the Director of Oncology Research Operations to assign protocols to staff and monitors compliance of research assistant staff to standards, policies and quality measures.
2.5 Coordinates and participates in the interview and selection process.
Education:
3.1 Trains new data staff members
3.2 Arranges associated training for NRG trials
3.3 Completes all related documentation in a timely manner; provides communication throughout the oncology research team on an on-going basis.
3.4 Utilizes available data bases and other files in a manner that is understandable and accessible to other members of the team.
3.5 Assists in developing educational sessions for monthly research meetings
Experience Required:
Experience
Required
Preferred
Special
Considerations
Experience
Required
Preferred
Special
Considerations
0-2 years
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6-10 years
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3-5 years
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10+ years
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Special Considerations
Explained (if needed):
Must have at least 3-5 years of experience. More than 5 years of experience strongly preferred
Experience in clinical research data management and cooperative group trials that may include project management.
Education Requirements:
Education
Required
Preferred
Special
Considerations
Education
Required
Preferred
Special
Considerations
High School / GED
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Bachelor’s Degree
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Vocational / Technical School
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Master’s Degree
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Associate’s Degree
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Doctorate Degree
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Field of Study (Please Note)
Biology, Research, Public Health, Business Administration, Healthcare Administration or related field
Special Considerations
Explained (if needed):
May substitute required education degree with additional years of equivalent experience or completed years of college on a one to one basis.
License/Certification Requirements:
Licensure, Certification, and Registration
Required
Preferred
Special
Considerations
Clinical Research Certification
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