Founded in 1819, the University of Cincinnati puts education into action, ranking among the nation's best urban public research universities. Home to more than 47,000 students, 10,500 faculty and staff and 330,000 alumni, UC combines a Top 35 research university with a physical setting The New York Times calls "the most ambitious campus design program in the country."
With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 athletic conference, UC's momentum has never been stronger. UC's annual budget tops $1.6 billion and its endowment totals $1.8 billion.
At UC, today's possibilities spark tomorrow's reality.
The College of Medicine, UC Cancer Center is looking for a Project Manager – Study Monitor. At the UC Cancer Center, our vision is to build a nationally recognized center that excels in cancer care, research, training and community impact and this role will serve as a key member of the Clinical Trials Office in support of these efforts.
Duties will focus primarily on study monitoring of human subjects research activities for compliance with the research protocol, FDA regulations & ICH-GCP as well as coordination of IITs (investigator initiated trials) throughout start-up and assisting with protocol writing and editing. Applicants with CRA, study monitoring, research, or oncology experience are encouraged to apply. This will be a primarily remote-work position, but occasional travel to the University of Cincinnati Clinical Trials Office or to other sub-site locations nationally (~5% travel annually) may be required.
The incumbent will actively participate, plan, and evaluate multiple, complex and/or multi-faceted research programs for one or more designated departments, programs, or central units. Duties can span a broad range of activities or be primarily focused within one or more areas of the clinical research spectrum.
Serves as the study monitor for PI held IND and FDA-regulated multi-center and single-center IITs – reviews site data within REDCap against source, reviews eligibility for subject registration, issues monitoring reports, provides regular communication to PIs and sites on study progress.
Maintains oversight of accrual and serious adverse event data and provides regular updates to PIs, sites, DSMB and industry partners on study progress.
Serves as a resource to site personnel for questions relating to the protocol/consent, edits the protocol and/or consent form as needed (IB risk changes or other clarifications) and collaborates with the regulatory team for IRB submission.
Assists in the initial development, writing and editing of IIT protocols and monitoring plans.
Serves as the primary point of contact for coordination of communications on the status of study start-up activities and ensures all stakeholders (contracting, fiscal, regulatory, data, lab, study team) are kept timely informed of status changes and assist in resolving actionable items.
Confirms sub-site feasibility and provides timely communication of study start-up status updates and assists in the resolution of actionable items to opening sub-sites to accrual.
Ensures sites are in receipt of required protocol and consent documentation and conducts all site initiation visits and ongoing training.
Maintains trial master file (TMF) of regulatory documentation from sub-sites in the CTO's electronic regulatory binder Complion.
Assists with the validation and testing of EDC guides, forms and design in REDCap for IITs.
Collaborates with data team members on preparations for data locks and preparing data for publication or the DSMB.
Develops educational materials and presentations based on monitoring findings and trends.
Other responsibilities as directed by the QA & Data Manager.
Performs related duties based on departmental need. This job description can be changed at any time.
Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
Five (5) years related experience.
Additional Qualifications Considered
Experience in an academic or clinical setting.
SoCRA or ACRP certification.
Physical Requirements/Work Environment
Sitting - Continuously
Compensation and Benefits
UC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.
Competitive salary range dependent on the candidate's experience.
Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
Tuition remission is available for employees and their eligible dependents.
Enjoy discounts for on and off-campus activities and services.
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.
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.