This position is located within a musculoskeletal research lab that currently focuses on clinical trials, epidemiology, outcomes, and genetics research on patients with rehabilitation and orthopedic conditions such as rotator cuff tears that cause shoulder pain.
This position will primarily work with a large clinical trial on rotator cuff tears called ARC: the Arthroscopic Rotator Cuff Trial.
ARC is a multi-site, national pragmatic study comparing physical therapy (non-operative) and surgical repair (operative) treatment for atraumatic rotator cuff tears.
ARC Trial Duties:
Create monthly study newsletters to be sent to all study personnel about updates to the study
Create biannual patient newsletters to be distributed to study participants and others that subscribe.
Assist with centralized study follow-up of study participants for all sites – sending and receiving study questionnaires and contacting participants directly via phone and email as needed.
Maintain records related to the conduct of clinical research – this includes copying/scanning forms, filing & electronically uploading study-related documents, and recording data directly into our electronic database called REDCap.
Maintain a system for filing paper records for all study participants.
Copy/scan & upload study-related documents as needed
MRI Collection Coordinate with local site coordinators to obtain MRI discs for all study participants from all sites b. b. Coordinate independent reading of MRIs by study radiologist
Coordinate payment of patients that submit questionnaires for the study and are due payment
Double data entry
Attend team research meetings to monitor and discuss ongoing research activities
Recruitment as needed:
Pre-screen patients each day from UTSW Clinics, Complete online screening logs, Track patients as necessary to confirm eligibility
Recruit & consent eligible patients in clinic – this involves going to specialty clinics at Vanderbilt and interacting with physicians, nurses and other clinic staff as well as having direct contact with patients
Administer baseline questionnaires and research procedures with patients who consent to participate in clinical research
Randomize patients in clinic in strict accordance with protocol procedures
Record patients’ study participation in EPIC Ordering supplies
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.
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.
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.