Job Details

Research Study Coordinator - Internal Medicine - Pulmonary & Critical Care

Job Number: 528923
Categories: Research & Laboratory Support
Location:
Dallas, TX

Department: Pulmonary and Critical Care
Full/Part Time/PRN: Full-Time
Regular/Temporary: Regular

 

 

 

 

 

 

 

 

 

Security


This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information

 

 

Salary


Salary Negotiable 

 

 

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. 

 

 

 

 

Job Duties


  • 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.
  • Performs other duties as assigned. 

 

 

ADDITIONAL JOB DETAILS:

Regulatory Management: This includes working on IRB submissions for Sponsor and investigator initiated studies, managing site start up and activation, managing protocol amendments, and Data Safety Monitoring Board reports. Managing and maintaining the regulatory and investigator site file binder for monitoring visits.  Tracking protocol deviations, IND safety reports and submitting them to the IRB. As well as conducting staff training for sponsor initiated studies. 

Start-up: This includes collecting FDA 1572's, signed CVs, medical licenses, signed financial disclosure forms and site affiliation forms.  Creating consent, HIPAA forms, and phone solicitation flyers to submit to Sponsor for review and approval.  Managing submissions/stipulations, review/re-submissions to eIRB. Keeping a site training and task delegation log. Conducting site activation visits and attendance at Investigator Meetings.  Lastly, managing the following databases: IWRS, EDC, Lab Portal, Intralinks and Safety Vifilance - Safety Report Tracker. 

Subject Visits/Patient Management:  Maintain the visit calendar, which includes scheduling study visits and locating a provider to conduct physical exams, locating an office to conduct the visit, scheduling additional subject procedures (e.g. eye exams, x-rays).  Conducting study visits, which include obtaining vitals, phlebotomy, performing PFT's, ECGs, providing questionnaires, and sweat testing. Processing samples and shipping samples to central laboratories.  Reviewing medical and medication history in Epic and corresponding with subjects on upcoming visits.  Charting in Epic, preparing visit, calibrating machines, data entry, managing EDC queries, collecting lab reports, retrieving signatures on labs, PFTs, and ECG results.

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; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.

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