Execute the following study procedures/assessments with proficiency: 1. collect/assess subject Adverse Events and/or Serious Adverse Events, 2. administer and document ICF process, as well conducting and documenting general study visits, 3. perform pulmonary function testing, 12-lead ECG, phlebotomy, lab processing/packing/shipping, and vital signs, 4. manage subject enrollment/recruitment for simultaneously enrolling studies, assuring eligibility according to inclusion/exclusion criteria, 5. Maintain regulatory binders, keep study ancillary supplies organized and accessible, coordinate patient recruitment, complete patient visits and/or phone calls by executing all patient procedures/assessments, and facilitate study monitoring visits and/or sponsor audits.