Case Western Reserve University
Clinical Research Database Coordinator
Case Western Reserve University, Cleveland, Ohio, us, 44101
Case Western Reserve University is committed to providing a transparent estimate of the salary for this position at the time of its posting. The starting wage rate is $22.13 per hour, depending on qualifications, experience, department budgets, and industry data.
Employees receive more than just a paycheck. University employees enjoy a comprehensive benefits package that includes excellent healthcare, retirement plans, tuition assistance, paid time off, and a winter recess.
Job Description
POSITION OBJECTIVE
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.
ESSENTIAL FUNCTIONS
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. (7%) 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. (7%) 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. (7%) Participate in various meetings and working groups with all the cancer center institutions. Identify problems and trends and develop and implement appropriate responses. (12%) NONESSENTIAL FUNCITONS
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. (2%) Perform other duties as assigned. (2%) CONTACTS
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.
SUPERVISORY RESPONSIBILITIES
None
QUALIFICAITONS
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).
REQUIRED SKILLS
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. Self-starter. 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. Detail oriented. Creative and independent thinking. Demonstrated history of successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest. 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.
WORKING CONDITIONS
General office environment; no chemical exposure. The employee will perform repetitive motion using computer mouse and keyboard. The position is eligible for the staff hybrid work program.
Hybrid Eligibility
This position is eligible for hybrid work arrangement up to two remote days per week at the discretion of the department. New employees may begin a hybrid schedule upon approval from the supervisor, successful completion of an orientation period and signing the remote work checklist certification form.
EEO Statement
Case Western Reserve University is an equal opportunity employer. All applicants are protected under federal and state laws and university policy from discrimination based on race, color, religion, sex, sexual orientation, gender identity or expression, national or ethnic origin, protected veteran status, disability, age and genetic information.
Reasonable Accommodations
Case Western Reserve University complies with the Americans with Disabilities Act regarding reasonable accommodations for applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the CWRU Office of Equity at 216-368-3066 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicants will be made on a case-by-case basis.
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Employees receive more than just a paycheck. University employees enjoy a comprehensive benefits package that includes excellent healthcare, retirement plans, tuition assistance, paid time off, and a winter recess.
Job Description
POSITION OBJECTIVE
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.
ESSENTIAL FUNCTIONS
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. (7%) 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. (7%) 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. (7%) Participate in various meetings and working groups with all the cancer center institutions. Identify problems and trends and develop and implement appropriate responses. (12%) NONESSENTIAL FUNCITONS
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. (2%) Perform other duties as assigned. (2%) CONTACTS
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.
SUPERVISORY RESPONSIBILITIES
None
QUALIFICAITONS
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).
REQUIRED SKILLS
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. Self-starter. 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. Detail oriented. Creative and independent thinking. Demonstrated history of successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest. 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.
WORKING CONDITIONS
General office environment; no chemical exposure. The employee will perform repetitive motion using computer mouse and keyboard. The position is eligible for the staff hybrid work program.
Hybrid Eligibility
This position is eligible for hybrid work arrangement up to two remote days per week at the discretion of the department. New employees may begin a hybrid schedule upon approval from the supervisor, successful completion of an orientation period and signing the remote work checklist certification form.
EEO Statement
Case Western Reserve University is an equal opportunity employer. All applicants are protected under federal and state laws and university policy from discrimination based on race, color, religion, sex, sexual orientation, gender identity or expression, national or ethnic origin, protected veteran status, disability, age and genetic information.
Reasonable Accommodations
Case Western Reserve University complies with the Americans with Disabilities Act regarding reasonable accommodations for applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the CWRU Office of Equity at 216-368-3066 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicants will be made on a case-by-case basis.
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