Clinical Research Manager UCCC

Profile

Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL

 

Founded in 1819, the University of Cincinnati embarks upon its third century - building on the past and defining the future by leading urban, public universities into a new era of innovation and impact through its strategic direction, Next Lives Here. Underscoring the power of creativity, ingenuity, invention and inclusion, what's Next will accelerate our unrivaled momentum, evidenced by eight straight years of record enrollment and rankings that include placement among America's top 100 public universities by U.S. News & World Report. Home to a diverse student body of nearly 47,000 and more than 4,200 distinguished faculty, the university combines its Research 1 (Very High Research Activity) Carnegie Classification with a physical setting that The New York Times recently acclaimed as the most ambitious campus design program in the country.

 

JOB OVERVIEW

As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children's Hospital Medical Center, College of Medicine's faculty are transforming the world of medicine every day.

The University of Cincinnati Cancer Center (UCCC) Clinical Trials Office is an institutional resource within the University of Cincinnati College of Medicine and UC Health that provides administrative, operational, and data management support for cancer clinical trials conducted by UC Investigators. The Clinical Research Manager oversees the implementation of clinical trials in the Clinical Trials Office (CTO).  S/he provides expert level knowledge in clinical trial practices and regulations and ensures compliance. Working under the direct supervision of the UCCC CTO Administrative Director and CTO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials, the Clinical Research Manager has duties that include but are not limited to:

ESSENTIAL FUNCTIONS

*Guides and directs a team of clinical research nurses and coordinators assigned to the various disease teams within the Clinical Trials Office. *Provides support, direction and coaching to clinical research coordinators in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation. *Provides daily management/supervision to the clinical research coordinators to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities within the Clinical Trials Office. *Oversees adherence to SOPs, Good Clinical Practice, and FDA regulations. *Ensures that accrual data and each subject data is entered into the Clinical Trial Management System (CTMS). *Assists CTO leadership in developing strategic planning goals and initiatives for clinical research. *Liaises and works efficiently in collaboration with the CTO Associate Director of Operations and with other departments at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation. *Interacts on a daily basis with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, CTO Associate Director of Operations to ensure all protocol requirements are met. *Works with study sponsors, IRB, and other regulatory offices as needed.

MINIMUM REQUIREMENTS

*Bachelor's degree, ideally in a health-related or scientific field *Minimum of 5 years of clinical research experience *Knowledge of clinical research, human subjects research ethics, and IRB procedures *Thorough understanding of Good Clinical Practice guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance.  *Strong qualitative skills and knowledge of study design. *Knowledge of medical terminology as well as the policies and regulations relevant to oncology clinical trials *Ability to build, lead, motivate, and assess a professional team *Excellent verbal and written communication skills in daily interactions with the ability to interpret and apply University of Cincinnati, UC Health policies and federal, state, and local regulations *Ability to manage multiple priorities, organize, and prioritize work to meet deadlines. *Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies *Knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)

ADDITIONAL QUALIFICATIONS CONSIDERED

*Master's degree with at least 3 years of supervisory experience *Nursing Degree and experience with management of oncology trials *Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) certification

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

*Sitting - Continuously

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.

 

REQ: 69525 

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Company info

The University of Cincinnati
Website : http://www.uc.edu