Manage and oversee the daily activities of the NCI Clinical Trials Reporting Program (CTRP). These activities and functions require detailed knowledge of the following: OnCore business rules, Protocol Review and Monitoring Committee (PRMC) and Institutional Review Board (IRB) policies, procedures and review and approval processes, NCI CTRP registration site and requirements, concepts of: protocol types, study designs and elements of protocol templates. Person in this position has the authority to make various decisions related to the Case CCC participation in the NCI CTRP such as which studies need to be registered and followed-up, what information has to be submitted, how to comply with CTRP requirements, how to ensure patient privacy and confidentiality in terms of protected health information (PHI), and others. Manage, generate, implement, obtain, and abstract a variety of information from the CTRP; including, procedures to process studies for the CTRP registration involving all aspects of required submission; relevant information from the protocols and the OnCore™ Clinical Trials Management System for registering all interventional clinical trials in the CTRP Registration Site; required documents, such as the IRB approval letters, protocols and consent forms, and other materials; reports from the CTRP site; and Case CCC Standard Operating Procedures (SOPs) related to CTRP activities. Submit to CTRP information such as numbers of all NIH grants, contracts and/or cooperative agreements supporting each registered trial; study amendments and updates to CTRP; and basic elements of patient accrual information (either via the CTRP Accrual Registration Web Site; or Accrual Batch file submission). All the activities and functions require working with the NCI-CTRP office, participating in NCI CTRP user teleconferences, as well as with principal investigators and study teams. (10%)
Manage and oversee of the daily activities of the ClinicalTrials.gov. These activities and functions require detailed knowledge of the following: OnCore business rules, PRMC and IRB policies, procedures and review and approval processes, ClinicalTrials.gov site and requirements, concepts of: studies done under INDs/IDEs, study designs, patient flow, patient demographics, outcome measures (e.g. patients’ response evaluation, end points), adverse events capture and classification, elements of biostatistics and elements of protocol templates. Review and determine appropriate actions related to the Clinicaltrials.gov such as which studies need to be registered and followed-up, what information has to be submitted, how to comply with ClinicalTrials.gov requirements, how to analyze and interpret both articles published in peer reviewed medical journals and raw study data and results; and how to ensure patient privacy and confidentiality in terms of Protected Health Information (PHI), and others. Manage and implement procedures to process studies for the ClinicalTrials.gov registration. Abstract the relevant information from the protocols and the OnCore™ Clinical Trials Management System for entering and submitting it to ClinicalTrials.gov. Submits study amendments and updates. Work closely with principal investigators and study teams to assure that all applicable trials are registered within required timeframes. (10%)
Register clinical trial results in ClinicalTrials.gov. This function is one of the most complex and difficult functions in this position’s responsibilities. The function requires knowledge of study designs, patient flow, patient demographics, outcome measures (e.g. patients’ response evaluation, end points), adverse events capture and classification, elements of biostatistics and elements of protocol templates. Person in this position has to assume a leading role for principal investigators and research teams in carrying out and completing clinical trials results registration; has to develop and revise forms and templates to facilitate gathering information for clinical trial results registration and Case CCC Standard Operating Procedures (SOPs) related to ClinicalTrials.gov activities. Person in this positon has to generate reports from the ClinicalTrials.gov site and work closely with Principal Investigators, biostatisticians and study teams to register clinical trial results. (10%)
Oversee the OnCore™ Clinical Trials Management Systems. Maintain reference codes for the OnCore Clinical Trials Management System, perform quality control and quality assurance activities, and monitor studies in OnCore on a regular basis for quality and accuracy of data. Work closely with investigators and study staff to ensure that data and information entered into OnCore are accurate and up-to-date and that they are entered in a timely fashion. (20%)
Identify problems and trends and respond appropriately. Develop and revise the Case CCC Standard Operating Procedures (SOPs) related to OnCore. (5%)
Participate in OnCore teleconferences and attend semi-annual OnCore meetings. These teleconferences and meetings provide a forum for all institutions using OnCore to: 1) Share their experiences and best practices; 2) Discuss with Forte current OnCore-related problems; 3) Provide to Forte ideas and suggestions for future OnCore versions and releases; and 4) Discuss with Forte any issues as they relate to OnCore data being extracted for CTRP and ClinicalTrials.gov reporting. Person in this position communicates and discusses outcomes of these teleconferences with OnCore Database Administrators and Clinical Trials Units staff, describing and discussing potential changes to OnCore data fields, reports and business rules. (5%)
Develop user manuals and implement training for new users in specific areas of need. As the Case CCC adopts a more complete version of the OnCore Clinical Trials Management System, extensive retraining of all OnCore users is required. Set up new user accounts in OnCore. For all users that do not already have Case Western Reserve University (CWRU) Network IDs, this includes registering users with affiliate IDs and coordinate the set-up of CWRU accounts with duo security. This function requires in-depth knowledge of OnCore, coordination with the CWRU information technology services (ITS) and robust computer literacy. Verify whether new users have CITI/HIPS Certification in compliance with CWRU policy and whether users have completed Securing the Human Training in compliance with CWRU policy. Post all OnCore user forms to the Cancer Center, Clinical Research Office website. (20%)
Produce various reports for Cancer Center grant renewal, annual progress reports, and for Case CCC leadership. Perform quality assurance on Data Table Four on a quarterly basis and provide this report to program leaders. Annually, provide Data Table Four to Cancer Center leadership for the CCSG progress report. Write jasper reports to extract information from OnCore using SQL and report configuring software. (15%)
Serve on the Minority Accrual Committee. Attend monthly meetings, post articles written or selected by the committee to the Cancer Center website, and provide data which contributes to projects managed by this committee. (5%)
Working under general direction, oversee and manage the various activities of registry and results data management for the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP). Manage the overlapping functions and ever-changing regulatory requirements between CTRP, OnCore™ Clinical Trails Management Enterprise System, and the ClinicalTrails.gov records for the Case Comprehensive Cancer Center/ University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute. Perform a variety of tasks in translating business and operational requirements into designs and specifications for workable solutions. Analyze business rules and process requirements. Identify and analyze ambiguous, conflicting work processes, information management, and reporting issues. Develop and refine business processes and entity relationships. Develop user manuals for applications and implement training to ensure accurate protocol information in a timely fashion. Perform quality control, quality assurance, write and run reports, provide data and analysis for various Cancer Center reports including annual progress reports, the Cancer Center Support Grant renewal.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
Perform other duties as assigned.
Department: Regular contact with supervisor, PRMC Manager, OnCore Database Administrators, and Case CCC administrative staff.
Internal: Case Western Reserve University, University Hospitals, and Cleveland Clinic: Contact with physicians, investigators, research nurses, regulatory and data coordinators, CWRU information technology services, and other departmental personnel involved in and/or assisting with research.
External: Contact with the National Cancer Institute, Food and Drug Administration, pharmaceutical sponsors, national and international cancer research Cooperative Groups, Forte Research System, representatives from other institutions and organizations.
Students: Little or no contact with students.
Experience: 3 years of work experience in a clinical research operations or research regulatory environment.
Education: Bachelor’s degree required (preferably in science or related area).
Understanding of process improvement/business processes.
Excellent intrapersonal and communication skills.
Excellent organization, planning and judgment skills.
Ability to work well with others.
Problem solving and conceptual skills.
Creative and independent thinking.
Understanding of medical terminology is a plus.
Knowledge of computer software, web design, structured query language (SQL), and databases.
Microsoft Office proficiency.
Ability to learn new programs and electronic information systems.
General office environment; no chemical exposure. The employee will perform repetitive motion using computer mouse and keyboard to type.