Working under general direction, oversee and manage activities related to registration and maintenance of all applicable trials in the National Cancer Institute (NCI) Clinical Trials Reporting Program (CTRP). Because of an overlap of functions and requirements between CTRP and ClinicalTrials.gov, the person in this position is also involved in registering applicable trials and trials results in ClinicalTrials.gov. In addition, the person performs quality control and quality assurance activities for the OnCore™ Clinical Trials Management Systems (OnCore), which, in turn, serves as a primary source of data for CTRP and ClinicalTrails.gov. Person works closely with investigators and study staff to ensure that the investigators and Case CCC comply with federal and all other requirements for trial registration in all applicable databases. By working closely with research teams, the person also ensures that all fields in the OnCore are populated with accurate protocol information in a timely fashion. Although the person in this position works closely and consults with the Case CCC CRO administrative director and PRMC manager; he/she functions on an independent level in terms of daily activities and decision making capacity.
Manage and have oversight of the daily activities of the NCI Clinical Trials Reporting Program (CTRP). Activities and functions described below 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 will have authority to make various decisions related, but not limited 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 and implement procedures to process studies for the CTRP registration involving all aspects of required submission.
Register in CTRP all interventional clinical trials categorizing them as externally peer-reviewed, institutional, and industrial trials.
Abstract the relevant information from the protocols and the OnCore™ Clinical Trials Management System for entering and subsequently submitting it to the CTRP Registration Site. All information and the required documents such as the IRB approval letter, protocol and consent form, other, are obtained from OnCore.
Work closely with principal investigators and study teams, and monitor OnCore data entries, to assure that all applicable trials are registered on the CTRP Registration Site prior to enrollment of first patient, as required by NCI policies.
Develop integration of the CTRP with OnCore by working with NCI, Forte Research Systems and OnCore database administrators. This function involves detailed knowledge of OnCore database with all the business rules, CTRP Registration Site, and CTRP policies and procedures.
Verify and troubleshoot protocol web summaries (Trial Summary Report, TSR and xml file) as developed by CTRP, and maintain the CTRP electronic protocol listing. This function requires understanding of CTRP reports in the light of submitted trial information. This file is subsequently used as part of the Clinicaltrials.gov registration.
Submit other data to CTRP as indicated by NCI, verify the summary information generated by CTRP staff and respond to CTRP inquiries about the information supplied.
Keep track and record all dates of the CTRP registration processes in protocol-based OnCore checklists.
Submit to CTRP numbers of all NIH grants, contracts and/or cooperative agreements supporting each registered trial.
Submit an on-going basis study amendments and updates. Amendment changes may include Principal Investigators, protocol title, participating sites, objectives/outcomes, study design, eligibility criteria, and other. If there have been no changes to the protocol within 1 year, trial updates are submitted annually.
Submit on a quarterly basis elements of patient accrual information (for Complete and Abbreviated trials) either via the CTRP Accrual Registration Web Site; or Accrual Batch file submission.
Develop and revise Case CCC Standard Operating Procedures (SOPs) related to CTRP activities.
Generate reports from the CTRP site. This function requires in-depth knowledge of CTRP Registration Site and the site’s searching and reporting capabilities. These reports are used to provide information to the Case CCC leadership and Case CCC CRO about Case CCC CTRP activities.
Communicate with NCI CTRP staff and participate in NCI CTRP user teleconferences. This function involves the following activities: Submit comments to CTRP via e-mail at NCICTRP@mail.nih.gov regarding issues and problems encountered in the trial registration, amendment, update, and patient accrual submission process; Provide feedback to CTRP on existing documentation and training materials. Respond to queries from CTRP. And participate in regular teleconferences with NCI and other participating in the CTRP institutions. These teleconferences focus on troubleshooting issues and bringing experience, expertise, and knowledge of all CTRP-participating institutions to help make the program successful. Person in this position communicates and discusses outcomes of these teleconferences with Forte, OnCore Database Administrators and Clinical Trials Units staff, suggesting potential changes to OnCore data fields, reports and business rules.
Oversee the manage the OnCore™ Clinical Trials Management Systems
Set up new user accounts.
Train new users on specific areas of need.
Perform quality control and quality assurance activities.
Design and develop protocol specific calendars.
Work 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.
Serve as a resource for investigators and research staff with respect to OnCore, CTRP and ClinicalTrials.gov.
Monitor studies in OnCore on a regular basis for quality and accuracy of data. This function requires: 1) Knowledge of OnCore and its business rules; 2) High attention to detail; 3) An on-going communication with investigators and research teams; and 4) Decision making authority regarding what information is needed, who should be contacted, how to assist study teams and what is the timeframe of the receiving the data.
Identify problems and trends and respond appropriately with guidance from the Case CCC CRO Director.
Train and educate of investigators and research staff in all aspects of OnCore utilization. This function requires presenting, teaching and public speaking skills.
Develop and revise Case CCC Standard Operating Procedures (SOPs) related to OnCore.
Generate various reports for Cancer Center grant renewal, annual progress reports, and for Case CCC leadership.
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 integration with CTRP and ClinicalTrials.gov. 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.
Manage and have oversight of the daily activities of the ClinicalTrials.gov. Activities and functions described below 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. Person in this position will have authority to make various decisions related, but not limited 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.
Submit study amendments and updates. This function requires monitoring of different types (major and minor) of study revisions to assure that applicable information is submitted within allocated timeframes.
Register clinical trial results. This function is one of the most complex and difficult functions in this segment of this position’s responsibilities. It 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 will have to assume a leading role for principal investigators and research teams in carrying out and completing clinical trials results registration.
Work closely with Principal Investigators and study teams to assure that all applicable trials are registered within required timeframes.
Work closely with Principal Investigators, biostatisticians and study teams to register clinical trial results. This function involves coordinating meetings and activities with different faculty and staff to discuss registration fields and elements to agree on an interpretation of study methods and outcomes.
Develop and revise Case CCC Standard Operating Procedures (SOPs) related to ClinicalTrials.gov activities.
Develop and revise forms and templates to facilitate gathering information for clinical trial results registration.
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, University Hospitals and Cleveland Clinic: Contact with physicians, investigators, research nurses, regulatory and data coordinators, 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: 2 to 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 programs and databases.
Microsoft Office proficiency.
Familiarity with databases.
Ability to learn new programs and electronic information systems.
General office environment; no chemical exposure.
In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity. Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.
Case Western Reserve University provides reasonable accommodations to applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Inclusion, Diversity and Equal Opportunity at 216-368-8877 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.
Case Western Reserve is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case...