The USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a CTRP Specialist and PRMS Associate to join its team.

Job Summary:   The Clinical Trials Reporting Program (CTRP) is a program that serves as a data source for clinical trials search tools, which help patients, physicians, and the public identify clinical trials. The CTRP also supports regulatory compliance and facilitates the registration of trials to ClinicalTrials.gov. This database helps identify gaps and duplicate studies in clinical research, facilitates clinical trial prioritization, and standardizes trial data capture and sharing. The Protocol Review and Monitoring System (PRMS) oversees the scientific aspects of cancer-related clinical research, ensuring that clinical trials are reviewed for scientific merit and align with the priorities of the Cancer Center. The National Cancer Institute (NCI) requires that all comprehensive cancer centers maintain a PRMS.

The primary role of this position is to oversee and manage USC NCCC clinical trial registrations and results reporting to the National Institutes of Health’s (NIH) ClinicalTrials.gov (CT.gov) and the National Cancer Institute’s (NCI) Clinical Trials Reporting Program (CTRP) in compliance with federal and institutional requirements. This role also requires evaluating and maintaining data systems, identifying requirements for the development of internal and external systems to meet reporting needs and providing training and guidance to faculty and staff on CTRP reporting requirements. In addition, this role is also responsible for providing assistance, as needed, to the PRMS coordinator. It's crucial to maintain awareness of regulatory changes, technological advancements, clinical and research processes, and standards of clinical research conduct.

SpecificJob Functions:

Project Management

Oversee the day-to-day operations of the CTRP for clinical trials, including but not limited to timely and accurate registration of new trials and submission of relevant data updates and result reporting for all adult USC NCCC clinical trials, including population science studies; however, the NCCC USC IIT will be the responsibility of the USC NCC IIT Protocol Development and CTRP Administrator  Provide assistance, when needed to the USC NCC IIT Protocol Development and CTRP Administrator to assure protocol language is applicable to CT.gov requirements and CTMS is set up to generate reports for submission.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. Work closely with USC NCC IIT Protocol Development and CTRP Administrator, and USC/CHLA CTRP Group to ensure compiled submissions meet the required criteria for accurate reporting.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.Assist PRMS Coordinator, as needed, with tasks including, but not limited to preparation of meeting agendas, generating meeting minutes and memos as well as ensuring that all required materials are available for review in a timely manner as well as monitoring adherence of the PRMS committees with the policies and processes as outlined in the USC NCCC Data and Safety Monitoring Plan (DSMP).Acquire knowledge of therapeutic areas, and current clinical developments and best practices.Ensure consistency and quality of all documents that are issued for CTRP submission.Effectively coordinate with relevant multidisciplinary team members to ensure on-time preparation and submission of required information to CTRP.Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work.

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.Understand, assimilate, and interpret sources of information with appropriate guidance.Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.

Data Management and Administration

Manage access and maintenance of ClinicalTrials.gov system for USC NCCC. Responsible to enter and maintain all adult USC NCCC trial CT.gov registrations, other than USC IIT, which are managed by the USC NCC IIT Protocol Development and CTRP Administrator. Responsible to enter and maintain results reporting for all adult USC NCCC trial CT.gov registrations, other than USC IIT, which are managed by the USC NCC IIT Protocol Development and CTRP Administrator. Responsible to enter and maintain or oversee entry and maintenance of all CTRP entries.Work closely with the IIT Protocol Development and CTRP Administrator to ensure timely and accurate reporting for the USC NCCC IITs

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. May attend conferences to keep current with advancements in the field; contribute to the development of conference coverage reportsMaintain collaborative, proactive, and effective communication with external, multidisciplinary and internal teams.Contribute to building and maintaining a positive team environment.

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.Solid working knowledge of relevant FDA, EMA, and ICH guidelines.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.Strong technical writing and editing skills including internal document consistency; ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.Excellent attention to detail and time-management skills. Ability to balance multiple projects simultaneously.Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques.Strong understanding of the document creation process and of the drug development lifecycle.Basic understanding of statistics or willingness and ability to learnAble to synthesize data across multiple data sources and documents to create summary reports.Ability to work collaboratively in a dynamic environment.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.

Preferred Qualifications

Preferred Experience: 5 years

Supervises: Employees and/or student workers.

Special Instructions to Applicants

Applicant Attachments (Required): Cover Letter and Résumé

Applicant Attachments (Optional): N/A

The hourly rate range for this position is $33.99 - $47.56. 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 consideration.

Minimum Education: Bachelor’s degree; Combined experience/education as substitute for minimum education Minimum Experience: 2 years; Combined experience/education as substitute for minimum experience Minimum Field of Expertise: 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.