Research Coordinator II



Job Purpose

The work involves helping with three NIH and DoD funded clinical studies in patients with traumatic brain injury. The coordinator will evaluate patients admitted to Ben Taub Hospital with a traumatic brain injury to determine if they are eligible for the studies. The first study involves long-term follow-up of patients who have been previously enrolled in our TRACK-TBI study. The coordinator will spend about 30% of the time on this project. The coordinator will spend about 30% of the time on this project.

The second study is a clinical trial of two ICU management strategies for patients with severe TBI. One arm of the study has their management guided by ICP and PbtO2 measurements, the control arm has their management guided only by ICP measurements. The goal of the study is to determine if adding PbtO2 monitoring improves long-term neurological outcome. This is a particularly challenging study because we have to enroll subjects within 6 hr of injury. The study is being conducted under the exception from informed consent for emergency studies. The coordinator will spend about 40% of his time on this study. The work involves evaluating patients admitted with severe TBI, and enrolling eligible patients. Once enrolled, they perform the randomization procedures and inform the neurosurgeons which arm they are randomized to. They also will connect the patient's bedside monitor to the study computer so that all of the physiological measurements are collected on the study computer system - also be able to troubleshoot this computer system. Then for the first 5 days after injury, the coordinator is responsible for collecting detailed information all episodes of increased ICP and/or PbtO2, for daily performing a check of the PbtO2 catheter functioning, drawing blood samples for biomarkers, obtaining the initial CT scan and submit it to the central site, and for recording what types of treatment were provided for ICP/PbtO2 episodes. For patients who are enrolled by the exception from informed consent, the coordinator will need to continue to try to locate an LAR for consent, and once found give them the opportunity to continue to participate or to withdraw. The work also involves educating the neurosurgeons about the study treatment protocols, and making certain that the protocols are being followed. Also involved in the work is keeping all of the regulatory documents up to date, answering data queries an audits, coordinating with the coordinating center, performing monthly follow-up phone calls and arranging for the final in person follow-up visit at 6 months post-injury. The third study is an observational study which will validate the point of care testing of two biomarkers of traumatic brain injury (GFAP and UCHL1) using the Abbott Laboratories iSTAT system. For this study, patients must be enrolled within 12 hours of injury. The coordinator will spend 30% of the time on this project. The work will involve evaluating patients that come to the emergency room with a traumatic brain injury and require a CT scan of the head for clinical evaluation. For patients who are eligible and who agree to participate, the research coordinator will consent them, collect some baseline demographic and injury characteristics, collect the CT scan of the head and submit it to the central site, draw a blood sample within 12 hours of injury, and again between 12 and 24 hr after injury, process the blood samples and perform the assays on the iSTAT machine. For patients who consent to optional study visits, the research coordinator will arrange the in person study visits at 2 weeks, 6 weeks, 3 months, and 6 months after injury and perform detailed neuropsychological testing, perform an MRI of the brain in CAMRI, draw a blood sample and process the blood sample.

Job Duties
  • Help enroll subjects in an observational study of traumatic brain injury.
  • Evaluating patients for eligibility, consenting them for the study, and then obtaining all of the required procedures at each study visit and entering the data obtained into a web-based database.
  • Schedule research participant for tests and procedures, such as laboratory tests, x-rays, and other studies specific for the research protocol.
  • Will obtain informed consent, and collect the data required by the study protocols. The study procedures include collection of clinical data, performing detailed neuropsychological outcome assessments, drawing blood samples and processing the blood samples for biomarkers, and performing a MRI of the brain.
  • The work involves contacting subjects once a year and inviting them to participate in a follow-up phone visit. After consenting them for the follow-up visit, they will arrange a time for a phone interview, where they will do some neuropsychological tests that can be done over the phone and also have them answer some surveys/questionnaires. Depending on how they answer the questions, they may be invited for an in person study visit.
  • At the in person study visits, the coordinator will perform more detailed neuropsychological testing, an MRI of the brain in CAMRI, a blood draw and processing of the blood samples. If they indicate that they might have had a seizure during the previous year, the coordinator will also arrange for an EEG and an interview with an epileptologist.
  • Keeping all of the regulatory documents up to date, coordination with the TRACK-TBI coordinating center, data entry and answering database queries, scoring of the neuropsychological tests, collection of the MRIs and submitting to central site, shipping blood samples to central repository, arranging Clincard payments to subjects, participating in any audits/site visits.
  • Involved in the work is keeping all of the regulatory documents up to date, coordination with the Abbott Laboratories coordinating center, data entry and answering database queries, scoring of the neuropsychological tests, collection of the MRIs and submitting to central site, shipping blood samples to central repository, arranging.
  • Clincard payments to subjects, participating in any audits/site visits. General: Interview, screen and recruit patients for study.
  • Explains process and procedures to educate participant regarding the research study.
  • Collects patient information.
  • Process, document and enter information into a database.
  • Maintains records and regulatory documents and records for research studies.
  • May perform Venipuncture (blood draws), EKGs/ECG’s and obtain vital signs on study participants. May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.
  • Retrieves and submits test results to appropriate party.
  • May correspond with patient throughout study.
  • Orders supplies and equipment.


Minimum Qualifications
  • Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
  • One year of relevant experience.


Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

6004

CA; CH

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