Working under general direction, the primary role of this position is to manage and utilize the clinical trials management system at the Case Comprehensive Cancer Center in order to comply for trial registration. This position supports the Case Comprehensive Cancer Center and Clinical Research Office to maintain high standards, devise new methods to make processes effective and efficient; provide guidance and assistance for clinical researchers and staff; and ensure quality of data. Under the clinical research office of the cancer center, the person in this position will oversee and manage activities related to the center’s clinical trials management system (OnCore®), which in turn serves as the primary source of data for reporting to the center leadership, National Cancer Institute (NCI), ClinicalTrials.gov (CTgov) and NCI/clinical trials reporting program (CTRP). This person works closely with investigators and study staff at participating institutions (Case Western Reserve University, University Hospitals and the Cleveland Clinic to ensure pertinent protocol/ subject data is entered into OnCore in real time so that the cancer center complies with federal and all other requirements for trial registration in all applicable databases.
Oversee and manage the OnCore® Clinical Trials Management Systems. Set up new user accounts. Work with university technology staff to ensure that all new users complete the appropriate training regarding HIPAA and HITEC guidelines concerning data and patient information. Coordinate and train new users on specific areas of need via one-on-one training and conducting monthly classes. Coordinate and present training and educate investigators and research staff in all aspects of OnCore utilization. Revise training materials as needed. Perform quality control and quality assurance activities and follow-up 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. Monitor studies in OnCore on a regular basis for quality and accuracy of data. (36%)
Serve as a resource for investigators and research staff with respect to OnCore. Develop and revise standard operating procedures related to OnCore. (12%)
Participate in OnCore teleconferences and attend semi-annual OnCore meetings. (6%)
Published quarterly clinical research office newsletter with information from the office regarding new features, process/ policy changes, upcoming events, and news worthy items in regards to OnCore, the clinical research office and the cancer center. (6%)
Work closely with the registrar (for ClinicalTrials.gov and National Cancer Institute/ Clinical Trials Reporting Program) to help with functions for reporting requirements. Ensure information generated by the NCI’s Data Table 4 is accurate and aligns with the OnCore generated report. Participate in CTgov/CTRP user monthly teleconferences. Assist with regular quarterly accrual maintenance in CTRP. Pull and deliver updated status reports to the registrar to keep national databases current. Generate various reports for cancer center grant renewal, annual progress reports, Minority Accrual Committee and for cancer center leadership. (12%)
Develop and revise standard operating procedures related to the clinical research office. (6%)
Participate in various meetings and working groups with all the cancer center institutions. Identify problems and trends and develop and implement appropriate responses. (12%)
Attend seminar and training sessions that pertain to data management to share any change in policies and procedures. (3%)
Cross train with cancer center support grant personnel for vacations and absences. (1%)
Perform other duties as assigned. (1%)
Department: Regular contact with supervisor, protocol review and monitoring committee manager, OnCore database administrators, and other administrative staff.
University: Contact with Case Western Reserve University, University Hospitals, and Cleveland Clinic: Contact with physicians, investigators, research nurses, regulatory and data coordinators, IRBs, and other departmental personnel involved in and/or assisting with research. Contact with university technology staff to maintain workflow.
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 to exchange information.
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).
Detailed knowledge of the following: OnCore business rules, protocol review and monitoring committee and institutional review board (IRB) policies, procedures and review and approval processes, ClinicalTrials.gov, NCI/CTRP registration sites and requirements, concepts of: protocol types, study designs and elements of protocol templates.
Understanding of process improvement/business processes.
Very good intrapersonal and communication skills.
Excellent organizer, planner, and trainer.
Ability to exercise judgment.
Ability to work well with others. Ability to interact with colleagues, supervisors, and customers face to face.
Problem solving and conceptual skills.
Medical terminology understanding.
Experience working in a research environment.
Creative and independent thinking.
Word and Excel proficiency, ability to learn new programs; electronic information systems.
Database software proficiency (Oracle, OnCore, RedCap or other Clinical Trial Management Systems).
Ability to meet consistent attendance.
General office environment; no chemical exposure. The employee will perform repetitive motion using computer mouse and keyboard.
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 Equity at 216-368-3066 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 University has implemented a COVID Vaccination policy requiring evidence of COVID-19 vaccination for all students, faculty and staff with an on-campus presence. Religious and medical exemptions may be provided in accordance with applicable federal and state laws. For more information go to: https://case.edu/equity/covid-19-accommodations. Applicants may contact the Office of Equity at 216-368-3066 /[email protected]
for information regarding religious or medical exemptions as an accommodation.