Coordinates daily activities of the clinical research study in
Pediatrics (renal, gastroenterology, infectious diseases,
endocrine, etc.) for the Pediatric Research Resources Office.
Primary responsibilities include key functions of the clinical
trials such as patient enrollment, screening, monitoring of
research participants, and reporting to the clinical research
sponsor. Responsible for ensuring accurate data collection,
documentation, organization and safety of study volunteers.
- Assists the investigator with the enrollment (recruiting,
screening, and interviewing) and study consent process of patients
into the Pediatric Clinical Trial Studies.
- Explains the study’s processes and procedures to educate the
- Responsible for assisting the Principle Investigator with
collecting and recording study data related to catherization
procedures, cardiac measurements, and related test and measurement
for the study.
- Assist the Principle Investigator as necessary with electronic
case reporting requirements in accordance with all FDA and clinical
trial study requirements.
- Collects patient information; processes documents and enters
information into a database.
- May perform research related procedures as required such as
venipuncture (blood draws) and obtain vital signs on study
- Corresponds with patient throughout study.
- Interacts with sponsors and/or coordinating sites as required
to facilitate protocol activities and maintains current study
- Collects, processes and stores or ships blood or biological
specimens as outlined per study protocols and associated lab or
procedural manuals, in accordance with IATA Guidelines.
- Maintains records for the research study.
- Schedules research participant for tests and procedures such as
laboratory tests, x-rays, and other studies specific study visits
for the research protocol.
- Retrieves and submits test results to the appropriate
- May assist with the supply orders and equipment necessary for
- Collaborates with physician, mid-level practitioners, and
research nurses and data managers to document patient care.
- Conducts subject research study education as required within
the scope of practice.
- Submits serious adverse event reporting and follow up as
- Evaluates and analyzes clinical research data as
- Bachelor's degree in a related field. Four years of related
experience may substitute for degree requirement.
- Two years of relevant experience.
- Therapeutic clinical trials experience
Baylor College of Medicine is an Equal Opportunity/Affirmative
Action/Equal Access Employer.