Senior Clinical Research Professional, Department of Emergency Medicine

Updated: almost 2 years ago
Location: Cincinnati, OHIO
Deadline: The position may have been removed or expired!

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

The Department of Emergency Medicine is seeking a Senior Clinical Research Professional who will serve as the research division’s regulatory coordinator in charge of regulatory submissions to the IRB and FDA, sponsor interface, document management and research compliance.  This team member will work with the clinical research professionals team that coordinates research studies in an acute care setting.


Essential Functions
  • Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
  • Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members.  
  • Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.
  • Ensure compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.
  • Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). Prepare and maintain FDA applications for Investigational New Drugs (INDs). Maintain regulatory documentation. 
  • Make and assist in modifying protocols and study documents.
  • Write reports, business correspondence, and procedure manuals. Consent writing and eConsent creation.
  • Conduct adverse event reporting.
  • Manage office documents including training certificates, CVs, and licenses.
  • Maintain clinicaltrials.gov listings.
  • Act as liaison between study personnel and data entry specialists. 
  • Perform related duties based on departmental need. This job description can be changed at any time.
     

Required Education
  • Bachelor’s Degree in Biology, Health Sciences, or a related field.
  • Seven (7) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Required Experience
  • Three (3) years of related experience.

Additional Qualifications Considered

  

  • Master’s degree.
  • Experience working in an academic research setting.
  • Experience with RedCap or eRegulatory.
  • Clinical Research Professional Certification.

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 dependant 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: 73145 

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


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