Full Job Description
Experience and Education
Master's degree in related field and one (1) year research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research.
Bachelor's degree in related field and three (3) years research data management and patient interviewing experience in delivery of health care services or experience in behavioral, social science, or clinical applied research.
Participates in patient recruitment ensuring proper informed consent, eligibility requirements are met and enrolls patient onto trial. Manage patients on research study ensuring all study required visits are completed per protocol. Maintains compliance with protocol requirements and all applicable regulatory requirements.
Performs accurate and complete data entry, case report form completion and query management. Maintains patient study binder per departmental guidelines including all elated source documentation. Ensure data is enter into clinical trial monitoring systems. Appropriately utilizes the electronic medical record for management of the patient on study and to communicate with clinical staff.
Participate in monitoring visits, site initiation visits and close-out visits as needed. Attends required training, maintains applicable certification and/or licensure as required. Attends regularly scheduled departmental or team meetings.
Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.
Coordinates all regulatory aspects, such as preparing safety reports, adverse events, FDA compliance, drug company monitoring, laboratory standards; and laboratory standards; maintains databases related to these regulatory aspects.
Coordinates aggregation and maintenance of local and national research data required to ascertain and identify research study outcomes; oversees and may perform entry of research data, coding, retrievals, adjustments, additions, and computer backups.
May develop and monitor budgets; negotiates participant rates; approves expenditures; pays invoices; reconciles accounts associated with studies.
Develops and prepares statistical research reports, charts, and graphs as required during research studies.
Assists in design of research survey forms to capture required participant information; interviews research study subjects and/or family members to gather research study information.
Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting proper informed consent; tracks subjects' information from multiple projects. Prepares informed consent forms for subjects' families.
Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects.
Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies. Informs Institutional Review Board of amendments to research studies; prepares protocols and detailed summaries in lay terms of any new research study.
May provide full supervision to personnel of lower grade.
Duties performed may include one or more of the following core functions: (a) Directly interacting with or caring for patients; (b) Directly interacting with or caring for human-subjects research participants; (c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or (d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
**Other Duties: Performs other duties as assigned.
Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.