Senior Research Coordinator
Coordinates day-to-day activities of the clinical research study, Pediatric Cardiac Output Monitoring Observational Study protocols for the Pediatric Research Resources Office – Neurology (RRO-Neurology). Primary responsibilities include 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.
- Assist the investigator with the enrollment (recruiting, screening, and interviewing) and study consent process of patients into the Pediatric Cardiac Output Monitoring Observational Study. Explain the study’s processes and procedures to educate the study participants.
- Collect and record 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.
- Collect patient information; process documents and enters information into a database. May perform research related procedures as required such as EKGs/ECG’s and obtain vital signs on study participants.
- Correspond with patient throughout study.
- Interact with sponsors and/or coordinating sites as required to facilitate protocol activities and maintains current study documents.
- Collect, process and store or ship blood or biological specimens as outlined per study protocols and associated lab or procedural manuals, in accordance with IATA Guidelines.
- Maintain records and regulatory documents and records for the research study.
- Schedule research participant for tests and procedures such as laboratory tests, x-rays, and other studies specific study visits for the research protocol.
- Retrieve and submit test results to the appropriate party.
- Assist with the supply orders and equipment necessary for the study.
- Assist in reviewing protocol documents, including abstracts, text, and informed consent for relevant information.
- Prepare documentation necessary to obtain initial and continued approval for the specific research protocol.
- Collaborate with physician, mid-level practitioners, and research nurses and data managers to document patient care.
- Conduct subject research study education as required within the scope of practice.
- Submit serious adverse event reporting and follow up as needed.
- Evaluate and analyze clinical research data as appropriate.
- Maintain online Research Resources Office project activity tracking log.
- Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
- Five years of relevant experience.
- Should be familiar with Cardiac procedures.
- Current certification (Certified Clinical Research Professional-CCRP, Certified Clinical Research Coordinator-CCRC) from a clinical research organization (SoCRA or ACRP)
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.