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Texas Health Resources Research Regulations Specialist PRN in Dallas, Texas

Texas Health Research and Education Institute seeks to hire a Research Regulations Specialist PRN to work as needed in their Research Administration Department.

The address is 8440 Walnut Hill Lane, Dallas, TX 75231.

Salary range is Minimum $23.54/hr. to Maximum $36.91/hr. – based on relevant experience

Work Schedule:

  • PRN; As needed

Job Description:

This position will perform duties that will support the development, implementation and regulatory maintenance of clinical trials for multiple sites and studies of different therapeutic areas and phases in accordance with appropriate regulations.

Essential Functions:

Study Start-Up

  • Complete pre-study documents including confidentiality agreements, feasibility questionnaires, and other requested documents.

  • Coordinate completion of documents with study coordinators and principal investigators.

  • Correspond with sponsors/CRO’s as needed.

Site/Study Selection, Sponsor and CRO Submissions

  • Responsible for initial submission of regulatory documents to the sponsors and CRO's.

  • Coordinate completion of documents with study coordinators and principal investigators.

  • Correspond with sponsors and CRO’s to ensure accurate and timely completion of all required documents.

IRB Submission

  • Initiate and complete IRB initial submissions to the THR IRB and central IRB's with principal investigators and study coordinators. This includes review, preparation and submission of required documents.

  • Provide support for principal investigators and study coordinators in submitting amendments, modifications, adverse events, and other documents as required to the IRB's.

Assist with Clinical Research

  • Will assist clinical research staff with consenting patients and other duties related to research as needed.

Qualifications

The ideal candidate will possess the following qualifications:

  • Bachelor’s Degree in a related field required or 4 years of relevant work experience in lieu of a degree

  • 1-year experience in a general clinical setting, clinical research, regulatory or legal experience with a Bachelor’s degree required Or

  • 5 years’ experience in a general clinical setting, clinical research, regulatory or legal experience with no degree required

  • Clinical Research experience highly preferred

Skills:

  • Ability to work consistently and effectively while managing multiple deadline driven tasks.

  • Work as a team player and independently, completing assigned responsibilities with minimal supervision.

  • Strong attention to detail.

  • Excellent interpersonal skills.

  • Computer literate to include working knowledge of Excel, Word and Outlook.

Why Texas Health Resources?

The Texas Health Research & Education Institute (THRE) is the non-profit research institute of Texas Health Resources that is responsible for — and supports — research endeavors and provides education about research across the 24 acute-care and short-stay hospitals that make up the Texas Health System.

Texas Health Highlights:

  • Fortune 100 Best Companies to Work For® 2020 (#15) (6th year in a row)

  • Fortune's list of Best Workplaces in Health Care (#1)

  • Employees’ Choice “Best Places to Work” by Glassdoor (2018 and 2019)

Employment opportunities are only reflective of wholly owned Texas Health Resources entities.

We are an Equal Opportunity Employer and do not discriminate against any employees or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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