Data Quality Monitor
Provides data quality assurance and training of Clinical Research personnel. Participates in the initial training in protocol management and data collection. Serves as a content expert and resource to clinical research personnel. Participates in development of the case report forms. Ensures that all processes contributing to the performance of the clinical trials are conducted in accordance with ICH/GCP guidelines and to ensure high quality and integrity of the research data.
The following are essential job accountabilities:
- Performs CRA data collection evaluations: Assist Senior Data Quality Monitor in data evaluations during the probation period for CRAs and data managers. Performs quarterly and annual data evaluation for the established CRAs and data managers. Reviews in-house clinical trial data for consistency, completeness, and timeliness in preparation for statistical analysis.
- Documents all the data monitoring findings. Reviews and explains all the findings with the CRAs and data managers. Based on the severity and quantity of the data errors, assists with re-training sessions for CRAs and data managers. Communicates all the findings with supervisors.
- Pro-actively advises on regulatory and data collection compliance in order to assist and support the clinical research team. Follows up as directed on all internal and external audits. Assists with action plans to assure the timely completion of corrective actions.
- Communicates with data management staff to resolve conflicts in data, request clarification, and secure incomplete data items.
- Serves as a section representative to Information Sciences and Clinical Trials Office (CTO) personnel, answering questions and providing support for data management personnel
- Participates in protocol management and data collection training for new and current staff. This includes on-site City of Hope staff as well as outside staff of those institutions for which City of Hope is the Data Coordinating Center.
- Education and audit preparation
- Actively participates in organizing and conducting monthly in-services for the clinical research staff.
- Assists with continuing education opportunities for the Clinical Research personnel.
- Assists with data collection monitoring and preparation for all COH external audits.
- Assists with the post-audit results from the QA perspective and assists with providing guidance and training as needed.
- Participates in the creation, maintenance and on-going improvement of Case Report Forms (CRFs) and data collection grids for COH clinical trials.
- Assists in the development of procedural and training manuals for the Data Management Section.
- Assists in developing tools to improve protocol management and data collection within DIS.
- Assists with the laboratory flow sheet and automated engraftment application
- Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure and/or keep abreast of latest trends in field of expertise.
- Is self-motivated in organizing and following through on assigned projects.
- Ensures work environment is organized and functions efficiently.
- Attends and participates in meetings as required.
- Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
- Performs other related duties as assigned or requested.
Minimum Education and Skills Required for Consideration:
- Bachelor’s Degree and Certified CRA. Experience may substitute for minimum education requirements
- At least 3 years’ experience working as Clinical Research Associate. Expertise in the Medical Record, Health Information Systems, or related health field preferred.
- Courses/training in medical terminology.
- Communicate technical information in a clear, concise manner
- Excellent oral/written communication and organizational skills.
- Excellent reading comprehension.
- Ability to monitor and train other employees.
- Ability to master content across all clinical research areas.
- Foster/promote a positive image and professional appearance Sensitivity to intercultural relations.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy. Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
City of Hope is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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