This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information Experience and Education
1. Master's degree in basic sciences, business administration, or related field and three (3) years progressive research/grant administration and coordination experience.
2. Bachelor's degree in basic sciences, business administration, or related field and five (5) years progressive research/grant administration and coordination experience.
Develops Quality Management Program for clinical research program to achieve accreditation.
Ensures regulatory compliance of clinical research program.
Develops and maintains website for marketing clinical research program.
Develops system for data collection and management of clinical research program registry information.
Coordinates development of clinical research program laboratory.
Coordinates interface between clinical research program and basic/clinical research collaborators at university and other institutions.
Provides general scientific support for clinical research program staff and university business office.
Assists in developing and implementing research studies to include writing clinical trials.
**Other Duties: Performs other duties as assigned.
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.
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.
UTSouthwestern 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 UTSouthwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.