Clinical Research Professional - Department of Obstetrics and Gynecology
Company: University of Cincinnati
Location: Cincinnati
Posted on: January 15, 2021
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Job Description:
Current UC employees must apply internally via SuccessFactors
> http://bit.ly/UCEMPLUC 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 Obstetrics and Gynecology is looking for a Clinical
Research Professional. Duties focus on regulatory affairs. This
position will support the University's mission and commitment to
excellence and diversity in our students, faculty, staff and all
our activities.Clinical Research Professional: Regulatory*
Knowledge of medical and pharmaceutical terminology and concepts,
as well as theoretical knowledge and/or bachelor's degree and/or
equivalent education and/or experience in a field related to
biological sciences as needed to work in Regulatory Affairs.*
Excellent communication skills with sponsors, coworkers, and
physicians.* Experience working with FDA regulations and procedures
and Good Clinical Practice guidelines for the conduct of clinical
research.* Prepare and submit research documents and reports, such
as FDA Forms 1572, start-up regulatory packets, initial IRB
submissions, safety letters, Serious Adverse Events (SAEs),
protocol amendments and annual continuing reviews. * Assist in
preparation of FDA audits, internal audits and monitoring visits.*
Prepare and maintain study regulatory binders to include all IRB
approved study documents, correspondence and other required
documentation. This includes maintaining study training, Delegation
of Authority logs and study certificates for research staff.*
Experience developing and maintaining record management systems.
Strong administrative and organization skills, experience
prioritizing assignments when faced with a heavy workload and
competing deadlines.* Draft Informed Consent Documents that comply
with UC IRB policies and procedures, FDA regulations, and sponsor
requirements.* Experience using standard word processing and data
management software programs, including Word and Excel, in order to
develop and prepare reports.* Experience with editing, including
summarizing information into concise and condense documents.*
Proven ability to determine sources of information and data and to
analyze the data and information obtained, in order to create
documents and to propose solutions to issues. Detail oriented,
logical, and methodological approach to problem solving.*
Demonstrated knowledge or demonstrated related experiences to
comprehend, interpret, and apply regulations and legislation
regarding the protection of human subjects. These include
regulations under federal policies, FDA, and other compliance
agencies or directive.* Maintain knowledge of UC Human Research
Protections Program (HRPP/IRB) policies and procedures and Central
IRB policies and procedures. * Related other duties, as
assignedMinimum Requirements:Bachelor's degree in related
discipline, or equivalent, preferred.One-year related experience,
preferably in an academic or clinical seng.For nursing-focused
role, current/valid RN license to pracce in the State of Ohio
required,, appropriate clinical procedural experience
required.Preferred Qualifications:For nursing-focused role, CR
cerficaon preferred.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: 57821SF:LJN (OMJ)
SF:RM SF:HEJ SF:INS SF:HERC SF:DIV
Keywords: University of Cincinnati, Cincinnati , Clinical Research Professional - Department of Obstetrics and Gynecology, Other , Cincinnati, Ohio
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