National Jewish Health Clinical Research Coordinator II in Denver, Colorado

Essential Responsibilities1. Is familiar with Good Clinical Practices, Food and Drug AdministrationRules and Regulations, NIH guidelines, HIPAA regulations and ICHguidelines in relation to clinical trials. If not already familiar, becomefamiliar with National Jewish Policy and Procedures with particular emphasisin conducting multiple clinical research trials.2. Is familiar with the purpose and the details of each protocol in whichhe/she will be involved (either as primary or backup coordinator)through review of the consent, protocol and IRB submission documents,avoiding deviations from the protocol.3. Works well as a member of the clinical research team with positive andtimely written and verbal communication, including sharing information up,down and laterally4. Recruits and interviews prospective subjects for multiple clinicalstudies, consistently meeting or exceeding goals.5. Familiarizes potential subjects with the details of the study throughphone contacts and personal interviews. Schedules subject participation inresearch, coordinating availability of necessary space, laboratory andphysician support.6. Properly dispenses study medication under the direction of the PrincipalInvestigator and/or Sub-investigators.7. Assures compliance with protocol, completion of necessary records,and scheduling of monitoring and subject visits.8. Is familiar with all records required for each study, reviews recordsafter each visit for completeness and accuracy.9. Transfers source documentation into Case Report Form (CRF) within 24hours of subject visit.10. Maintains patient NJH and clinical research files, including updatingmedical history, allergies and concomitant medications on an ongoing basis.11. Shows initiative to identify and implement ways to improve their job andsurroundings.12. Seeks supervision appropriately. Plans work in a manner that allowsadequate completion of all tasks. Follows through on assignments in a timelymanner.13. Serves as a contact person for ongoing clinical research studies. Meetswith representatives from sponsoring pharmaceutical firms or in-house stafffor initial orientation to studies and for review of study records.14. May be called upon to perform the following specific tests andprocedures: a) spirometry, b) electrocardiogram, c) prick andintradermal skin testing, d) blood pressure, pulse, height,weight, and temperature measurements e) nasal allergen challenges &nasal sampling, f) phlebotomy and specimen processing, g) methacholinechallenges, h) breath condensate testing, i) nitric oxide measurements(nasal and/or pulmonary), j) sputum induction, k) bronchoscopyassisting, l) data collection and formatting into Excel forBiostatistics, as n15. Demonstrates accuracy in all details, is able to record and reportproperly in patient records all pertinent information.16. Performs subject competencies (including age-specific competencies)as identified through the departmental competency program. Maintainscompliance for training for specific tests and procedures, as needed per NJHpolicy and study protocol.17. Implements care and services that recognize age-specific needs and issuesfor customers served. Performs as a back-up to staff absences and vacancies,as necessary.18. Demonstrates adherence to the policies and procedures established by bothNJH and their specific Unit. This includes but is not limited to, time andattendance policies.19. Performs all other duties as assignedGeneral Responsibilities1. Performs, as directed, safety compliance and uses PersonalProtective Equipment (PPE), as needed.2. Participates in Quality Assessment (QA) and Quality Improvement(QI) programs, as directed.3. Ensures compliance with The Joint Commission and all other Federal,State and Regulatory Agencies.4. Responds promptly and sincerely to customer's needs, requests andconcerns via all communication forms using easily understood language andrefraining from using inappropriate l