The University of Cincinnati 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, Department of Neurology and Rehabilitation Medicine is recruiting for a full-time (100% FTE) Clinical Research Project Manager to perform as the NIH StrokeNet National Coordinating Center (NCC) Project Manager.
Job Duties and Responsibilities:
Collaborate with the PPI, NCC, NDMC and performance site trial team members to ensure successful conduct of clinical trials by managing daily study activities.
Interact with clinical site personnel about matters concerning compliance and verification of the trial, FDA and CIRB regulatory requirements, contractual requirements, and shipment and receipt of investigational products.
Track progress and provide authorization to begin site enrollment based on the predefined criteria for each required component of a trial.
Maintain database/tracking tools which track site and subject enrollment as well as other elements pertinent to the trial execution.
Serve as a liaison between performance site personnel, the PPI, the NCC, and the NDMC trial management teams to enforce adherence to study protocol, the trial MOP, and SAE reporting.
Assist in the development and maintenance of the trial MOP.
Attend and assist in preparation of DSMB and Trial Investigator meetings.
Collaborate to contribute content to the monthly study update newsletters for participating sites.
Assist in the coordination of conference calls, such as the steering, executive, and scientific advisory committees, and face-to-face AHA Conference investigator meetings or other national meetings.
Interface with CIRB liaison regarding site CRIB approvals, annual renewals, and reporting of SAEs.
Interface with data management team regarding site and data quality issues.
Participate in site initiation visits and staff training as deemed necessary for the trial.
Skills and Characteristics Needed:
Ability to assist with the coordination of research studies in a particular discipline.
Ability to make independent contributions to projects and studies based on professional training or functional experience.
Must be able to interact with study sites in a professional manner.
Can accomplish work under general direction.
Capable of advising and explaining information to others.
Ability to manage moderately complex projects.
Ability to work with the NCC leadership to accomplish the necessary NCC tasks, in addition to short- and long-term goals.
Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence.
Qualifications and Requirements:
Bachelor’s degree in natural sciences or an equivalent combination education/experience.
At least five (5) to ten (10) years of directly related work experience, preferable in an academic or clinical setting
Additional Qualifications Considered:
Minimum of three (3) years of experience directly involved with clinical research or similar experience in medical field preferred.
Proficiency with regulatory guidelines for clinical trials
Proven organizational ability and strong attention to detail.
Demonstrated decision-making and problem-solving skills.
Excellent time-management skills, communication and interpersonal skills (written and oral), and computer skills including word processing, spreadsheet, and PowerPoint are required.
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: 49201-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.