Clinical Research Program Administrator

The USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking a IIT Protocol Development and Clinical Trials Reporting Program (CTRP) Administrator to join its team.

Job Summary:

This position entails providing support for the USC NCCC IITs as a scientific writer and editor as well as working within the interdisciplinary clinical trials teams to produce high quality clinical trials including, but not limited to protocol amendments, informed consent forms and applicable protocol forms and manuals, ensuring compliance with local, state and federal regulations as well as develop protocol templates that meet required elements of the FDA, other regulatory agencies and USC NCCC internal review committees. Also responsible for maintaining up to date records of the USC IITs in the ClinicalTrials.gov (CTG) and the NCI's Clinical Trial Reporting Program (CTRP) systems as well as review and analyze federal regulations on the conduct of clinical research to stay current on policy and guidelines to ensure high quality Investigator Initiated clinical trials managed by the Clinical Investigations Support Office (CISO). In this role it is crucial to maintain awareness of regulatory changes, technological advancements, clinical and research processes, and standards of clinical research conduct. Performs related responsibilities as required.

Key Responsibilities include:

Project Management

• Assists principal investigators with developing and editing complex FDA/ICH/GCP-adherent submission-level clinical documents such as study protocols, investigator brochures, clinical study reports, and annual reports, by interpreting regulatory and clinical data clearly, accurately, and concisely and within the designated timelines.
• Acquire knowledge of therapeutic areas, and current clinical developments and best practices.
• Work closely with study statistician to ensure statistical design and planned analysis is clearly outlined in the study protocol.
• Ensure the consistency and quality of all documents that are issued.
• For all relevant IIT documents, coordinate and manage the review process, lead discussions on document revision and conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers.  Revise documents based on reviews by quality assurance, statistics department, investigators, and other stakeholders.
• Assists in drafting and editing Standard Operating Procedures (SOPs), guidelines and writing tools, such as templates and style manuals relevant to CISO IIT processes.
• Development, implementation, and oversight of processes for CTRP submission to ensure that all USC NCCC IIT 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.
• For USC NCCC IIT trials, 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.
• Attend meetings with DSCi (informatics) and USC/CHLA CTRP group and follow up on action items for completion.
• Effectively coordinate with relevant study team members to ensure on-time preparation and submission of regulatory documents, such as study amendments, interim analysis, abstracts, manuscripts as well as scientific publications.
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work.

Compliance

• Understand, assimilate, and interpret sources of information with appropriate guidance.
• Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking).
• 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 USC NCCC IIT ClinicalTrials.gov and CTRP.  Guide and implement policies and Standard Operating Procedures (SOPs) related to data collection, management, reporting and submissions for USC NCCC IIT.
• Serve as a back up to develop, plan and offer stakeholder and end user training and support related to compliance with CT.gov and CTRP.
• Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.

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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. 
• Responsible to enter and maintain all adult IIT 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

• May attend conferences to keep current with advancements in the field; contribute to the development of conference coverage reports
• 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. 
• Maintain 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 learn
• Able 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.

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. Supervises Level: May oversee student, temporary and/or casual workers.