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Regulatory Support Specialist

Position Information

Position Information (Default Section)

Faculty Rank or Job Title Regulatory Support Specialist
Job Category: Research
Department Research Affairs-SOM
Equity & Inclusion No.: 17H113
Position FTE

100%

Minimum Annual or Hourly Rate $18.00 /hr.
Salary Band: UC HR4
Job Summary/Basic Function:

To support the collection, preparation, submission, and maintenance of clinical trials regulatory documents by completing applications and other required documentation and obtaining necessary signatures. Maintains accurate Institutional Review Board files in both electronic and hard-copy formats.

Minimum Qualifications

Bachelor’s degree required, preferably in a science or medical related field. This position requires proficiency with computers (email, Microsoft Office [Word, Excel], navigating the Internet). The ideal applicant is detail-oriented, has excellent written and oral communication skills, and is comfortable working in a deadline-oriented environment.

Preferred Qualifications

Clinical Trials documentation experience.
Familiar with Institutional Review Boards (IRB) and Commercial IRB’s.
Completion of a Good Clinical Practices training course.

Essential Functions and percent of time:

70%: Supports the collection, preparation, submission, and maintenance of clinical trials regulatory documents including obtaining necessary signatures. Completes submission applications and other required documentations. Maintains accurate Institutional Review Board files in both electronic and hard-copy formats.

Prepares protocol specific informed consent forms and summaries for submission to various review committees, including internal scientific review boards, the Institutional Review Board, and sponsoring entities. Completes amendment applications, and maintains record of all adverse event reports. Regularly interfaces with trial sponsors, CROs, IRBs, Principal Investigators and study coordinators.

Essential Functions and percent of time (cont'd):

20%: Provides support to prepare for site qualification visits, site initiation visits, and monitor visits to ensure quality standards are met and business practices adhered to.

Non-Essential Functions and percent of time:

10%: Keeps current on all federal and state laws, regulations and guidelines governing human subject research; attends education and professional seminars to stay current in areas related to human subject research compliance.

Working Conditions

Regular office environment

Special Contract terms and conditions of employment apply. Length of contract is one year, renewable, contingent on funding.

To preserve the safety and security of the campus community and to maintain the integrity of university operations, it is the policy of Wright State University before making an employment offer conduct various background checks, such as a criminal record, credit history when job related and/or education verifications. Additionally, an administrative review shall be conducted whenever the university learns that an employee is charged with or convicted of a crime (except for minor vehicle violations).
Frequently asked questions related to background checks may be found on the human resources website at http://www.wright.edu/human-resources.

Special Instructions to Applicants
Posting Date 04/13/2017
First Consideration Date: 04/19/2017
Closing Date
Open Until Filled Yes

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this position at Wright State University? Please select an answer below:
    • Referred by personal contact
    • Job/Career Fair
    • Wright State University Careers website
    • LinkedIn
    • Twitter
    • Monster.com
    • CareerBuilder.com
    • Dayton Daily News
    • Dayton Weekly
    • HigherEdJobs.com
    • HERC (Higher Education Recruitment Consortium)
    • Local Newspapers
    • Other
  2. * Do you have a bachelor's degree?
    • Yes
    • No

Required Documents

Required Documents
  1. Cover Letter
  2. Resume/CV
Optional Documents