Title:  Research Coordinator III

Summary

Position coordinates activities of complex clinical research studies in Pediatric Critical Care Medicine. 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. Position requires prior clinical research experience and able to work independently with minimal oversight. Experience with Pediatric Critical Care setting and studies is a plus.

Job Duties

• 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
• Performs research related procedures as required such as venipuncture (blood draws),EKGs/ECG’s and obtain vital signs on study participants.
• Corresponds with patient throughout study.
• Interacts with sponsors and/or coordinating sites as required to facilitate protocol activitiesand maintains current study documents.
• 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 and regulatory documents and 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 party.
• Assists with the supply orders and equipment necessary for the study
• Assists in reviewing protocol documents, including abstracts, text, and informed consen for relevant information.
• Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.
• 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 needed.
• Evaluates and analyzes clinical research data as appropriate.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Pediatric Critical Care Medicine experience