Clinical Research Coordinator II

Location
Fort Worth, TX
Posted
Apr 12, 2017
Institution Type
Four-Year Institution

POSITION INFORMATION

Requisition Number
5149

Job Title
Clinical Research Coordinator II

Department
Surgery - 300760

Quick Link
www.unthscjobs.com/applicants/Central?quickFind=59868

Shift
Day

Department Overview
UNTHSC is one of the nation's distinguished graduate academic health science centers, dedicated to education, research, clinical care and community engagement. UNTHSC has a number of interdisciplinary Health Institutes, the mission of which is to develop creative solutions to health problems through leading edge, interdisciplinary research. The TB-Clinical Research team conducts clinical trials in partnership with the CDC's Tuberculosis Trials Consortium. The TB team is hiring a Coordinator, with a primary focus in compliance of clinical research and related activities to ensure performance in accordance with Federal Regulations, as well as sponsoring agency's policies and procedures. This coordinator will work with PIs and department staff as they execute and coordinate daily clinical research activities according to the organization's SOPs, study protocols, GCP and FDA/ICH guidelines.

Position Details
The Surgery Department at the University of North Texas Health Science Center is seeking to hire a Clinical Research Coordinator II to join our team.

Responsibilities of the position include but are not limited to:

* Execute and coordinate daily clinical research activities according to the organization's SOPs, study protocols, GCP and FDA/ICH guidelines.
* Oversee clinical research document management.
* Liaise with sponsors and all relevant IRBs.
* Perform regular internal audit (QA) of patient records, both locally and for sub-sites, to ensure compliance.
* Assist with development and implementation of research compliance education and training for all research staff, including regulatory processes, protections of subject, conflict of interest, and responsible conduct of research.
* Attend appropriate educational opportunities to maintain knowledge of current research compliance topics.
* Coordinates with PIs and department staff to help ensure that clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures.
* Support site staff in conducting patient evaluations, including but not limited to: obtaining and maintaining informed consent, compliance with study protocol schedules, study participant education, study enrollment, determining qualification based on study eligibility requirements, data quality management, conducting clinical evaluations, obtaining blood samples, vital signs and other necessary tests, reviewing medical history, maintaining source documentation, completing case report forms, etc.
* Support Pharmacy Manager in conducting internal audits (QA) of investigational product storage, dispensing and administration logs.
* Travel may be required.
* Accomplish other duties as assigned.

The University of North Texas System is firmly committed to equal opportunity and does not permit - and takes actions to prevent - discrimination, harassment (including sexual violence), and retaliation on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, family status, genetic information, citizenship or veteran status in its application and admission processes, educational programs and activities, facilities, and employment practices. The University of North Texas System immediately investigates and takes remedial action when appropriate.

The University of North Texas System also takes actions to prevent retaliation against individuals who oppose a discriminatory practice, file a charge, or testify, assist or participate in an investigative proceeding or hearing.

Required Qualifications
The successful candidate will possess a Bachelor's degree in health related field and three (3) years of experience, or equivalent combination of education and experience in clinical research.

Preferred Qualifications
The preferred candidate will possess the following additional qualifications:

* Master's degree and CCRC/CCRP certification is preferred.
* Foreign language proficiency (particularly Vietnamese or Spanish ) is a plus.
* Familiarity and comfort with technology, particularly electronic record keeping, source documentation and data capture.
* Strong analytical, organization, time management and decision-making skills.
* Expertise and knowledge of GCP and FDA/ICH regulations.

Special Instructions to Applicants
Applicants must submit a resume and a cover letter with their online application.

Pay Rate
Commensurate with Experience

Pay Basis
Monthly

Job Type
Full-Time

Work Schedule
M-F

Application Types Accepted
Main Form

Occupational Exposure to HIV/HBV?
Yes

Occupational Exposure to Hazardous Chemicals?
Yes

Occupational Exposure to Tuberculosis?
Yes

Security Sensitive?
Yes

Require a valid Texas Driver's License?
Yes

Require a certification?
No


MINIMUM REQUIREMENTS

Official Job Title
Clinical Research Coordinator II

Job Open Date
04-11-2017

Job Close Date
Open Until Filled

Job Category
Professions

PI97495176