UT Southwestern Medical Center-posted 5 days ago
Full-time • Mid Level
Dallas, TX
5,001-10,000 employees

Works under the direction of an Investigator(s) with limited supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of research data in support of multiple and/or complex research studies.

  • Maintains required subject documentation for each study protocol.
  • Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person.
  • Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.
  • Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI.
  • Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes.
  • Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.
  • Assists in developing and implementing research studies, may include writing clinical research protocols.
  • Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.
  • May provide supervision to other members of the research team as necessary.
  • May perform research billing activities, as needed, based on size of department (including linking patient calendars
  • Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.
  • Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals.
  • Coordinates data management and collection for national (larger/more complex) research studies.
  • Serves as lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.
  • Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents.
  • Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies.
  • Provides in-service training to all study team members and communicates to involved groups.
  • Reviews research study protocols to ensure feasibility requirements of the study.
  • Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.
  • Enters data in the assigned clinical trial management system, electronic medical record and/or other required data entry systems.
  • 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.
  • Bachelor's Degree in medical or science related field
  • 4 years of clinical research experience with Bachelor's Degree
  • Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience.
  • May consider additional years of experience or advanced degree in lieu of education or experience, respectively.
  • (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
  • (CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.
  • ACRP of SOCRA certification a plus.
  • Active phlebotomy License or Certification
  • Bi-Lingual in English and Spanish
  • Previous experience in a clinical research environment working with geriatric patients
  • PPO medical plan, available day one at no cost for full-time employee-only coverage
  • 100%25 coverage for preventive healthcare-no copay
  • Paid Time Off, available day one
  • Retirement Programs through the Teacher Retirement System of Texas (TRS)
  • Paid Parental Leave Benefit
  • Wellness programs
  • Tuition Reimbursement
  • Public Service Loan Forgiveness (PSLF) Qualified Employer
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service