The University of Cincinnati is a premier, public, urban research university; ranked as one of America’s top 26 public research universities by the National Science Foundation. U.S. News has ranked UC in the Top Tier of America’s Best Colleges. The Chronicle of Higher Education calls UC a “research heavyweight”. Forbes, Delta Sky and Travel + Leisure magazines have named UC one of the most beautiful campuses. #HottestCollegeInAmerica. UC is one of the largest employers in the Cincinnati region, employing over 15,000 full time and part time faculty, staff and student workers.
The College of Medicine, Cancer Programs is looking for a Clinical Research Professional. This position will support the University’s mission and commitment to excellence and diversity in our students, faculty, staff and all our activities.
Under general supervision of the Data & QA Manager, the Clinical Research Professional provides data management support and assistance to the University of Cincinnati Cancer Institute Office of Clinical Trials. Duties can span a broad range of activities, or be primarily focused within one or more areas of the clinical research spectrum.
This role is not anticipated to have patient contact and will be primarily office-based.
Clinical Research Data Entry/Management and QA Activities
Accurately enters data from electronic medical records, or paper research charts, into study specific electronic data capture systems in a timely manner for industry-sponsored, cooperative group, or investigator initiated clinical research trials.
Proactively seeks to promptly resolve outstanding data queries and any issues relating to missing or incomplete source documentation through collaboration with clinical research coordinators (CRCs).
Maintains and uses organizational systems (excel, EDCs, etc...) to track subject visits or other research milestones in order to avoid delinquent data entry.
Reviews all data entered into EDCs and subject charts to identify and help resolve any general QA issues with CRCs and QA staff as needed. (i.e., data collected per protocol and meets GCP, ALCOA standards etc...).
Communicates and collaborates within assigned research team and with principle investigators in a professional, helpful and service-oriented manner to effectively accomplish job duties.
Acts as the primary point of contact for monitoring visits – ensuring monitors have access to records, facilities, and remaining available for questions for the duration of a visit.
Assists the PRMC/DSMB Coordinator or other QA staff with projects as needed.
Adheres to all UCCI CTO work instructions, SOPs, and study specific time-frames in the performance of study data management and related job duties.
Clinical Research Protocol, Case Report Form (CRF) and Database (EDC) Development
Attends IIT & PRMC committee meetings and actively provides input on protocol data capture considerations to PIs (form design, OnCore or RedCAP database builds).
Communicates and collaborates effectively with Principle Investigators and Clinical Research Coordinators to design, implement, and maintain protocol specific forms (CRFs, checklists, protocol calendars etc...).
Able to independently maintain and meet form & database development milestones effectively (e.g., forms and checklists are developed and tested prior to enrollment of subjects).
Communicates effectively with Regulatory staff to ensure any changes to study procedures are reflected in any study tools or databases or forms in a timely manner.
Designs forms and calendars in OnCore and creates projects & forms in RedCAP for investigator initiated protocols (both single and multi-center as needed).
Designs and implements other evaluation tools for research projects.
Coordinates the generation of reports or supporting data for manuscripts and proposals.
Performs routine data reporting from OnCore and RedCAP or other data systems.
Skills and Characteristics Needed:
Must be able to interact and communicate with clinical research staff, PIs, and industry sponsors in a professional manner.
High attention to detail and organizational ability and ability to prioritize tasks
Can accomplish work independently.
Capable of advising and explaining information to others.
Ability to manage moderately complex projects.
Working knowledge of, and ability to apply, Good Documentation Practices, ALCOA, and ICH-GCP to data management, form and database design.
Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence.
Minimum Requirements: Bachelor's degree in related disciple, or equivalent preferred. Must have at least one year research experience, preferably in an academic or clinical setting.
Additional Preferred Qualifications: Prior experience in clinical research coordination or clinical research data management, and OnCore/RedCAP systems preferred.
NOTE: This position does not qualify for Visa sponsorship.
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.
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Internal Number: 44785-en_US
About University of Cincinnati
HISTORY IN BRIEF - The University of Cincinnati is a public urban serving research institution that was founded in 1819 and today is one of the country’s largest universities offering more than 350 academic programs to more than 44,000 students. UC has many top ranked programs in areas such as Music and Arts, Medical and Human-Services, Criminal Justice and more. Located in an urban setting, UC is close to the heart of Cincinnati and allows easy access for students to enjoy all that the city offers. UC is also the alma mater of many notables such as President William Howard Taft; Albert Sabin, developer of the oral polio vaccine; Astronaut Neil Armstrong and Mary Weinberg, 2008 Olympic gold medalist. UC is classified as a Research University (Very High Research Activity) by the Carnegie Commission and is ranked as one of America’s top 35 public research universities by the National Science Foundation. UC jumped 17 spots in the U.S. News & World Report rankings in the past two years alone. In addition to being named a “green university” by Princeton Review, UC has been named one of the world’s most beautiful campuses by Forbes and Delta Sky magazines. Learn more at www.uc.edu.MISSIO...N STATEMENT - The University of Cincinnati serves the people of Ohio, the nation, and the world as a premier, public, urban research university dedicated to undergraduate, graduate, and professional education, experience-based learning, and research. We are committed to excellence and diversity in our students, faculty, staff, and all of our activities. We provide an inclusive environment where innovation and freedom of intellectual inquiry flourish. Through scholarship, service, partnerships, and leadership, we create opportunity, develop educated and engaged citizens, enhance the economy and enrich our University, city, state and global community.