University of North Texas Health Science Center - Clinical Research Coordinator II
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.