Investigator-initiated Trial Management Supervisor
2 weeks ago
The USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking an Investigator-initiated Trial Management Supervisor to join its team.
This is a leadership role in CISO which is designed to provide support and oversight for the design and development of investigator-initiated trials (IIT) and their required clinical trial databases. The investigator-initiated clinical trial management supervisor will work very closely with USC/Norris Cancer Center physician-scientists, various CISO services and teams, Data Science Shared Resource and other cancer center core services to ensure that IITs are of the highest quality. The scope of the role includes oversight of protocol writing support, review of protocol documents for clarity and consistency, and management of the clinical trial database design and implementation.
The IIT Management Supervisor will organize and coordinate the activities of individuals in the Clinical Investigations Support Office (CISO) and the Data Science Core (DSC); DSCi (Informatics) which programs the databases and makes sure that these data are securely stored in databases, and the Biostatistics which analyzes the data. This person will also work closely with CISO Director and Associate Director in ensuring optimal support for IIT development and data management.
**Specific** **Job Functions**:
- Provides guidance, support and coordination of the activities of the CISO protocol writer(s)
- Reviews USC Norris Comprehensive Cancer Center investigator-initiated study protocols for clarity and completeness related to the description of the study objectives, eligibility criteria, and study efficacy, safety, or other endpoints, as these relate to the data requirements for the study.
- Work with the study principal investigator, lead statistician, and Clinical Investigation Support Office (CISO) to identify all data elements required to accomplish the study analytic objectives and to ensure adequate safety and other monitoring that may be required.
- Coordinate development of a master user specification (MUS) document that describes in detail all data requirements for a study and how they will be implemented into the database. The MUS will describe in detail the specific electronic case report forms (eCRFs) that are required, the data elements within each eCRF, the content and type of the data elements, the internal data element names and external data element labels and descriptive text, and the simple and complex data validations required to ensure data quality and completeness.
- Oversee testing and finalization of the eCRF implementation. Perform and/or supervise the performance of modifications to the eCRFs necessitated by study amendments or other eventualities.
- Develops and maintains a collection of Standard Operating Procedures relevant to the implementation of CDMS systems as described above.
- Serve as the primary liaison between the Cancer Center and the database vendor support representatives assigned to the Cancer Center.
- Coordinate data locks and preparations for data analysis with CISO and DSC/Biostatistics
**JOB QUALIFICATIONS**:
- Master’s degree preferred or bachelor’s degree in a scientific or medical discipline with at least 3 years of experience in clinical research in academic, healthcare or industry settings.
- Interpersonal skills necessary to provide effective project management and to develop and maintain cooperative working relationships with investigators, research staff, and other institutional personnel necessary to organize and coordinate their efforts on a research project.
- Analytical abilities necessary to prepare research proposals, protocol and data monitoring plans; critical thinking and problem-solving skills necessary to identify issues and implement appropriate responses.
- Experience in issues related to experimental and clinical study design, especially with respect to study data
- Understanding of the organization of databases and/or CDMS systems and their technical implementation.
- Excellent written and oral English skills. Ability to communicate clearly in writing and in person, and ability to participate productively in interactions with senior level leadership.
**Special Instructions to Applicants**
Applicant Attachments (required): Cover Letter and Résumé
Applicant Attachments (Optional): Letters of reference
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