Clinical unit oversight and management (including leading performance and improvement efforts for the unit, time approvals, leave requests, workload assessment and reassignment of work as needed, direct recruitment efforts, training, onboarding and professional development of clinical research staff, task delegation, establish and reinforce clear measurable performance expectations, creation of SOPs, workflows, metrics and collaboration with leadership and support staff to implement and change policies/procedures, coordination of internal quality control activities), unit compliance (including all internal and external regulatory and institutional requirements, attending relevant trainings, meetings, Tumor Boards, monthly lunch and learns, provide in-service education related to assigned protocols to ensure compliance, QA & QC, ensuring cooperation w/audits, monitor visits, addressing adverse events and protocol deviations/violations and communicating with PI, fiscal audits to ensure compliance with billing practices, ensures entering/tracking of protocol/regulatory information in the CTMS), protocol activation (including guiding new protocols through the process of activation, point person for the designated Disease Site Groups as protocol is reviewed by the DSG, Feasibility, and Scientific Review committees, oversees regulatory submission of new protocols for assigned DSGs and development, attend IRB meetings as needed) and study coordination (including subject and family education regarding medical aspects of protocols, testing procedures, visit schedules, side effects of therapeutics , appropriately executed documents and documentation

Trauma Team Lead, Certified Pediatric Emergency Nurse (CPEN), TNCC, ACLS/BLS, PALS, ENPC, Chair – Unit Based Council, Chair – Minor Care Committee, Triage RN certified. Plans, provides, and monitors individualized nursing care in response to specific patient needs. Provides developmentally appropriate psychosocial and clinical care respective to the emergent patient population

Supervises CTO clinical research professionals conducting UH Cancer Center clinical trials ensuring patient safety, clinical outcomes, work force assignments and work processes support program goals. Provides oversight to ensure appropriate research support is provided for projects, investigators, Hawaii Cancer Consortium Institutions, and community sites conducting NCI, pharmaceutical and investigator initiated trials. Directs program quality assurance by ensuring adequate staff training and operating procedures are in place. Directs regulatory staff to ensure all regulatory requirements are adhered to. Ensures deliverables are met for all grant funding or contracts awarded to support the CTO roles and responsibilities. Primary liaison with external local and national organizations sponsoring and otherwise supporting the Center’s clinical research enterprise. Supervises 24 research professionals. Oversees, analyzes and develops the CTO budget. Develops, negotiates, and provides preliminary approval for project/study budgets on industry, investigator-initiated, and cooperative group trials. Develops and implements continuous process improvement measures to ensure clinical trial enrollment goals are met. Directs training and education activities for research professionals and investigators. Directs the assistance of PIs with protocol writing, informed consents, and development of data capture mechanisms. Currently managing the operations of over 170 clinical trials (70 actively accruing, 100 with subjects in follow-up).

Project management and oversight for clinical research trials for NMR/MRI Research, UH. NIH Clinical Trial Network coordination. Patient populations include neonate to adult age groups, HIV and substance abuse subjects, PTSD, TBI, cognitive disabilities, and ADD/ADHD. Supervision and training of coordinators, graduate assistants, post docs, and visiting MDs who were conducting clinical studies at the site (Queen’s). Multiple IRB interactions including UH, WIRB, QMC, and TAMC IRBs. Recruitment from local facilities to include ambulatory clinics, Tripler AMC, community clinics, KPHC, LIFE Foundation and others. Subject recruitment, screening, protocol management, follow-up, adverse event reporting, study medication management/administration, regulatory, data management, departmental SOPS, and care coordination.

Collects, organizes, catalogs, disseminates, and maintains regulatory documents of current trials. Determines whether data is clinically significant and reports results that warrant prompt action to the physicians. Conducts weekly study meetings to site PIs/SubIs as well as to international affiliates. Maintains and updates QA processes and SOPs to ensure highest research standards and compliance. Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practice. Assists with monitoring audits/visits for protocols. Initiation and contract review of new studies including study cost analysis and site initiation visits. Works with CROs and other organizations to ensure proper participant enrollment, follow-up and data collection. Local, CONUS, and OCONUS travel to support protocols as needed.

Provide comprehensive nursing care to acute and ambulatory cardiology patients including identification of life-threatening conditions in the absence of the physician and initiating proper emergency measures. Counseling and education of patient and family members for standard of care cardiology health maintenance in the acute, ambulatory, and investigational setting. Super vision and training of research personnel including RNs and research assistants. Supervision of post docs, research fellows, and lab analysts in carrying out research activities. Conduct training for staff on research protocols, STEMI protocol, biohazard safety, HIPAA, and CITI. Ensure research is conducted per GCP and CITI standards. Maintain regulatory documents. Track and ensure patient compliance with medication/treatment regimens and follow-up appointments including vital statistics on chronic noncompliance/no-shows. Maintain data files and spreadsheets per protocol and FDA regulations. Coordination with providers as needed and when assessment indicated. Identification of barriers to treatment and implementation of interventions. Maintain research laboratory per Code of Federal Regulations. Maintain and update Standard Lab Operating Procedures and lab guidelines. Operation, maintenance and inventory of hemodynamic monitoring devices for standard of care as well as investigational uses. Dispense medication and maintain records. Prepare initial, continuing review, study close-out, protocol revisions, etc for IRB submissions. Submission of study updates for milestone grant and industry payments. Adverse event reporting. Maintain regulatory documents as mandated by FDA regulations. Collaborate with biopharm reps/techs. Conduct and oversee clinical trial protocols for Department of Cardiology to include responsibilities of Clinical Research coordinator below. Salaried position including carrying pager, after hours, weekends and on-call. 24 hour supervisory responsibilities.

Coordinating clinical research trials for academic cardiology research department including recruitment, informed consent, iv and phlebotomy, assessments and concomitant medication evaluation, EKG, cath lab, CCU and ED interventions. Experience with WIRB and local IRB, regulatory, adverse event reporting and adjudication, sponsor driven device and drug trials and translational/basic science research coordinating.

Informed consent process, recruitment/retention, IRB approvals/updates, protocol implementation, clinical assessments including phlebotomy, interviewing, medical & medication history, EKG, ankle brachial index, vital signs, SPPB, cognition testing, lab results interpretation and reporting, adverse event and outcomes reporting, regulatory, documentation, specimen collection/processing, hand grip strength, participant safety, FDA and NIH guideline adherence, participation in weekly study meetings, and scheduling.

• Assessing, intervening, and stabilizing the emergent patient, triage• Delegation and communication within the health care team – MD, PA, ARNP, RT, EMT, etc.• IV therapy, medication administration, conscious sedation, phlebotomy/specimen collection• Computer skilled, managing heavy daily patient volume, critical thinking, and prioritization • Proficient in all documentation/record maintenance/paperwork to ensure accuracy and patient confidentiality

• Assessing, intervening, and stabilizing the emergent patient, triage• Delegation and communication within the health care team – MD, PA, ARNP, RT, EMT, etc.• IV therapy, medication administration, conscious sedation, phlebotomy/specimen collection• Computer skilled, managing heavy daily patient volume, critical thinking, and prioritization • Proficient in all documentation/record maintenance/paperwork to ensure accuracy and patient confidentiality

• Highly skilled medical research professional in the fields of pharmacology and Krabbé disease• Proficient in laboratory assay procedures including ELISA, PCR, viral & bacterial cultures, drug resistance/sensitivity, and routine clinical tests