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Clinical Research Manager, Regulatory, UC Cancer Center

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

 

Founded in 1819, the University of Cincinnati ranks 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, eight straight years of record enrollment, 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 $1.9 billion.

 

Job Overview

As one of the oldest medical schools in the country, the UC College of Medicine 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.

 

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, nursing, 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. The incumbent will work 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.

 

Position is primarily remote work with some on-site requirements.

Essential Functions

  • Guide and direct a team of regulatory clinical research professionals assigned to support the various disease teams within the Clinical Trials Office.
  • Provide support, direction and coaching to the regulatory team in the areas of hiring, training, staff learning and development, disciplinary action, problem resolution, planning, and work assignment delegation.
  • Primary responsibility for overseeing regulatory clinical research professionals who are responsible for submitting protocols to clinical research committees (e.g. Institutional Review Board (IRB), Protocol Review and Monitoring Committee (PRMC), etc.).
  • The Regulatory Clinical Research Manager is directly responsible for ensuring protocols are appropriately shepherded through the regulatory process in order to meet the goal of protocol activation for research participant accrual in accordance with institutional and federal (National Cancer Institute) requirements.
  • Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment.
  • Provide 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.
  • Oversee adherence to SOPs, Good Clinical Practice, and FDA regulations.
  • Ensure that regulatory information is entered into the Clinical Trial Management System (CTMS) and e-Regulatory System.
  • Assist CTO leadership in developing strategic planning goals and initiatives for clinical research.
  • Liaise and work 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.

Essential Functions Continued

  • Interact on a daily basis with the CTO Clinical Manager, CTO Data and Quality Assurance Manager, CTO Associate Director of Operations to ensure all protocol requirements are met.
  • Work with study sponsors, IRB, and other regulatory offices as needed.
  • Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments. Work with necessary parties to identify compliance, legal, IP and business/financial risk.
  • May serve as Principal Investigator on select research projects.
  • Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

  • Bachelor’s Degree
  • Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience

Five (5) years related experience.

Additional Qualifications Considered

  • Experience in an academic or clinical setting.
  • SoCRA or ACRP certification.
  • At least 3 years of supervisory experience.
  • Experience with management of oncology trials.
  • Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) certification.
  • 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).

Physical Requirements/Work Environment

  • Office environment/no specific unusual physical or environmental demands.

 

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.

 

REQ: 88208 

SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN

Clinical Research Manager, Regulatory, UC Cancer Center

Date:  Sep 21, 2022
Location: 

Cincinnati, OH, US

Facility:  Main Campus


Nearest Major Market: Cincinnati

Job Segment: Clinical Research, Medical Research, Compliance, Cancer Research, Healthcare, Legal, Research