Research Study Coordinator - Physical Medicine & Rehabilitation
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POST DATE 8/21/2020
END DATE 9/20/2020
UT Southwestern Medical Center
JOB DESCRIPTIONExperience 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.
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 multi-center study on the genetic epidemiology of rotator cuff tears called cuffGEN. This large study will collect patient outcomes and saliva samples to determine the genetic variants associated with rotator cuff tendon disorders.
cuffGEN Trial Duties:
1. Recruitment of subjects within clinic
a. Pre-screen patients each day from UTSW Clinics
b. Complete online screening logs
c. Track patients as necessary to confirm eligibility
d. Recruit & consent eligible patients in clinic - may involve local travel to specialty clinics
e. Administer baseline questionnaires and research procedures with patients who consent to participate in clinical research
2. Responsible for centralized, primary data entry of study documents for all sites
3. Work with participating sites to ensure that source documentation is properly completed
4. Reconcile data error checks reported by study data analysts, checking against source documentation
5. 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 REDCap.
6. Establish & maintain a system for filing paper records for all study participants
7. Copy/scan & upload study-related documents as needed
8. Work with participating sites to onboard and train study personnel
9. Assist with scheduling Advisory Board meetings (scientific, stakeholder, DSMB, etc.)
10. Provide study project manager with regular progress reports on follow up and any issues that arise
11. Mail study-related materials to sites as needed
12. Attend team research meetings to monitor and discuss ongoing research activities
13. Assist with preparation of materials for publication, including typing/editing of manuscripts.
14. Create informational materials related to research study for dissemination to study participants, researchers, and community.
15. Update information on study website as needed.
16. Assist with administrative and regulatory tasks related to the trial as needed
17. Follow-up of study participants
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.