This position entails managing day-to-day operations and system applications associated with Clinical. Trials.gov (CTG) and the NCI's Clinical Trial Reporting Program (CTRP) for all adult USC Norris Comprehensive Cancer trials. The Clinical Trials Reporting Program (CTRP) Specialist will collaborate with Investigators and Statisticians to ensure timely analysis and reporting of results to relevant entities. Responsibilities include reviewing new clinical research protocols, drafting study regist... more details
The USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a Clinical Trials Reporting Program (CTRP) Specialist to join its team.
Job Summary:
This position entails managing day-to-day operations and system applications associated with ClinicalTrials.gov (CTG) and the NCI's Clinical Trial Reporting Program (CTRP) for all adult USC Norris Comprehensive Cancer trials. The Clinical Trials Reporting Program (CTRP) Specialist will collaborate with Investigators and Statisticians to ensure timely analysis and reporting of results to relevant entities. Responsibilities include reviewing new clinical research protocols, drafting study registrations, documenting objectives, determining data reporting timelines, and documenting changes throughout the study's life cycle.
Additionally, the role involves evaluating and maintaining data systems, identifying requirements for the development of internal and external systems to meet reporting needs. The Specialist will also provide training and guidance to faculty and staff on CTRP reporting requirements. It's crucial to maintain awareness of regulatory changes, technological advancements, clinical and research processes, and standards of clinical research conduct.
Key Responsibilities include:
Project Management
- Development, implementation, and oversight of processes for CTRP submission to ensure that all applicable trials are identified, submitted, and tracked for the trial life cycle.
- Consultation with investigators, Data Science Core (DSC) and DSCi (informatics) for investigator initiated trials (IIT) to assure protocol language is applicable to CT.gov requirements and CTMS is set up to generate reports for submission.
- Collaborate with NCI, Cancer Center Leaders, and DSCi (informatics) on annual reporting to the NCI and related subprojects. This may involve participating in the analysis of certain data and reconciling data across systems to ensure accurate reporting.
- Mapping sources of data for each system. Collaborate with DSCi (informatics) to devise and implement quality assurance of data elements.
- Hold regular meetings with DSCi (informatics) and USC/CHLA CTRP group and follow up on action items for completion.
Compliance
- Plan and implement processes to produce reliable and compliant data and submissions for CT.gov and CTRP. This includes identification of critical data values, developing Standard Operating Procedures, and developing and validating data collection instruments.
- Serve as the principal resource and subject matter expert for compliance with ClinicalTrials.gov and CTRP for NCCC. Guide and implement policies and Standard Operating Procedures (SOPs) related to data collection, management, reporting and submissions.
- Develop, plan and offer stakeholder and end user training and support related to compliance with CT.gov and CTRP.
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Results Reporting of NCCC investigator-initiated trials to ClinicalTrials.gov
- Collaboration with Principal Investigators and Statisticians to ensure Results Reporting complies with ClinicalTrials.gov timelines and format and accurately reports the outcomes of the research.
Data Management and Administration
- Manage access and maintenance of ClinicalTrials.gov system for NCCC.
- Responsible to enter and maintain all adult NCCC trial CT.gov registrations.
- Responsible to enter and maintain all results reporting.
- Responsible to enter and maintain or oversee entry and maintenance of all CTRP entries.
Networking and Collaboration
- Develop networks and actively participate in national conversations on CT.gov and CTRP.
- Initiate and participate in collaborations with key stakeholders within NCCC and at other academic research institutions/cancer centers relating to best practices, quality improvement projects, SOPs, and work processes.
Perform any other tasks assigned by the supervisor or CISO management to improve department performance, processes & procedures. The university reserves the right to add or change duties at any time.
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.
- 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.
The annual base salary range for this position is $101,821.40 - $$ 127,896.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.
Minimum Education:
Bachelor's degree
Additional Education Requirements
Combined experience/education as substitute for minimum education
Minimum Experience:
3 years of related experience with specialized research and/or programs.
Addtional Experience Requirements
Combined experience/education as substitute for minimum work experience
Minimum Skills:
Related experience with specialized research and/or programs (e.g., counseling, teaching).
Ability to analyze and evaluate data, and present findings.
Excellent interpersonal and written and oral communication skills, able to problem solve and lead conflict resolutions.
Ability to interpret and apply policies/analyses/trends.
Preferred Education:
Master's degree
Preferred Experience:
5 years of related experience with specialized research and/or programs.
Preferred Skills:
Related special education, licensing, or certifications based upon program content and services.
Proven ability to lead and guide others.
USC is an equal opportunity, affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC will consider for employment all qualified applicants with criminal histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring ordinance. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at uschr@usc.edu. Inquiries will be treated as confidential to the extent permitted by law.
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