Research Coordinator II
Texas Medical Center-Houston, Texas
UTHealth School of Dentistry
Requisition #: 180001PM
The position reports to the Director of Clinical and Translational Research in the Office of Research in coordination with the Clinical Research Committee and the Associate Dean for Research. This position has oversight for clinical projects and responsibility for ensuring project completion within specifications, working along with project investigators. The coordinator assists with project development, establishes operational objectives and assignments, defines and manages project resource needs, timelines and budgets, reporting; analyzes, compares and evaluates courses of actions. The coordinator will advise Principal Investigators (PIs) and other stakeholders to assist with research project design and identify resources, timelines and budgets needed to support each project. The coordinator will interpret sponsor requests for application/sponsor guideline for supporting projects. Communicate with prospective sponsors regarding School of Dentistry’s Clinical Research infrastructure and resources to support clinical research.
Location: Texas Medical Center
Position Key Accountabilities:
Assesses the administrative guidelines and contractual requirements of the clinical research
Ensures that regulatory requirements are in place prior to project initiation (IRB, HIPAA, FDA, ICH, study budgets, billing calendars, patient consents, clinicaltrials.gov study registration, etc.)
Ensures proper identification of billing responsibilities through completion of billing risk assessments and review and approval of coverage analyses.
Reviews and analyzes documentation related to the management of clinical research including confidentiality disclosure agreements, contracts, sponsor budgets, coverage analysis, financial reports, and clinical research billing.
Assists with designing source documents, recruitment materials, and other study documents
Oversees the management of clinical research space and resources.
Helps PIs and clinical support staff to enroll patients, coordinate pre-site visits, site visits, study initiation, ensure research procedures are properly coded in AxiUm, and assists in enrollment reporting.
Coordinates and schedules clinical trial reviews and monitoring.
Prepares reports outlining the review and validation of clinical research/trial projects including monitoring results, recommendations for corrective actions, and training needs.
Meets and disseminates regulations or university policy to researchers, statisticians, faculty members and departmental administrators to provide updates and guidance on clinical research finance and administration.
Serves as liaison between the faculty and sponsors during contract negotiation and by providing justification, documentation, and policy/guideline interpretation to stakeholders. Interacts with and builds good working relationships with all parties involved in the management and conduct of clinical research.
Helps to negotiate and prepare complex clinical research project contracts and clinical research coverage analysis.
Helps review budgets and related documents for clinical research projects to ensure compliance with sponsor, State, UT System, and institutional requirements.
Helps coordinate project account setup with the post-award team and prepares financial documents and clinical trial account closeouts.
Assist Wellness Center as needed.
Performs other duties as assigned.
Excellent communication skills both written and verbal.
Working knowledge of MS Office.
Bachelor’s degree or two years of clinical research experience in lieu of every year of education plus certification from the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Research Administrators Certification Council (RACC), Certified IRB Professional (CIP) or, Regulatory Affairs Certification (RAC). If applicant has a bachelor’s degree, certification is not required.
Five years of relevant experience. May substitute required experience with equivalent years of education beyond the minimum education requirement.
Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.
This position may include work involving potentially hazardous chemical, biological or radioactive agents.
This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215
University of Texas Health Science Center at Houston (UTHealth)
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine G. McGovern Medical School. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital.
UTHealth offers a comprehensive and competitive benefits package. For more information on our benefits programs please refer to the UTHealth Office of Benefits Website.
Equal Employment Opportunity Statement
UTHealth is committed to providing equal opportunity in all employment-related activities without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, gender identity or expression, veteran status or any other basis prohibited by law or university policy. Reasonable accommodation, based on disability or religious observances, will be considered in accordance with applicable law and UTHealth policy. The University maintains affirmative action programs with respect to women, minorities, individuals with disabilities, and eligible veterans in accordance with applicable law.