Kimberly M. Swint

email: acuj4o@r.postjobfree.com cell: 858-***-****

SUMMARY

Versatile Healthcare Professional with broad experience in drug Regulatory Affairs and Nursing. Has a quality and compliance mindset focused on continuous improvement and actively seeks to learn new skills to broaden knowledge base. Diverse therapeutic background in Oncology, Medical/Surgical, Nephrology, and Geriatric Nursing. Team oriented and is able create a positive relationship across functional areas to quickly generate results.

PROFESSIONAL EXPERIENCE

December 2013 - Present

Regulatory Affairs Associate Beta Pharma, Inc. Princeton, NJ

• Participated in and responsible for Health Canada Pre-NDS meeting minutes. Prepared briefing information for Pre-NDS meeting for Health Canada’s BMORS and Australia’s TGA.

• Created and maintain Commitment Tracking database.

• Assist with the coordination, review and preparation of clinical trial applications, ensuring compliance with the Food and Drug Administration (FDA) and international regulations and interpretations.

• Author, coordinate regulatory sections and review IND annual reports and sequence updates to ensure compliance with the Food and Drug Administration (FDA) and international regulations and interpretations.

• Alert the Regulatory Management to issues and potential problems, delays and/or deficiencies, and make recommendations as appropriate.

• Schedule, track project/operational activities, such as labeling reviews and approvals.

• Monitor various regulatory agency websites for new regulations, guidance documents and pertinent agency meetings.

• Prepare Regulatory Standard Operating Procedures and Work Procedures.

• Maintain and compile information for all IND sequence updates and Annual Report submissions.

• Utilized SharePoint and File Transfer Protocol (FTP) DropBox for IND submission and sequence updates.

• Early phase/preclinical IND development for potential FDA and CFDA submission

• Informed Consent and Protocol amendment submissions to IRB for NSCLC Study

• Participated in Site Initiation Visit with Roswell Park Cancer Institute for NSCLC Study

• Responsible for registering and managing Oncology Study information on ClinicalTrials.gov via Protocol Registration and Results System (PRS).

• Assisted with Phase 1 study start up activities for NSCLC study for US and Thailand.

• Pre IND and IND development for current targeted therapy program submission to CDER Oncology Products II

May 2007 – September 2013

Unit Manager Nursing Villa Rancho Bernardo Health Care San Diego, CA

• Managed and assumed 24-hour responsibility and accountability for resident care on assigned unit.

• Managed the unit in accordance with policy and procedure, State and Federal regulations to promote high quality care and service.

• Ensured complete and prompt reporting of incidents with follow-up as necessary to Administrator and Director of Nursing.

• Participated in the development and implementation of new policies and procedures based on identified needs.

Page 1 of 4

References Available Upon Request

Kimberly M. Swint

email: acuj4o@r.postjobfree.com cell: 858-***-****

• Actively participated in the Quality Assurance process, including attendance at Quality Assurance meetings and submission of required reports.

• Performed daily rounds on unit to ensure resident care needs and environmental standards are met, this includes monitoring of dining room during meal times.

• Developed, implemented, evaluated therapeutic services that resulted in optimal health and or safety outcomes for patients in accordance with CMS standards. Ensure accurate diagnosis, care plan, informed consent, and nursing documentation meets annual survey standards.

• Responsible for staff continuing education and enforcement of HIPAA standards relating to patient care/safety.

• Routine audits and evaluation of pharmaceutical and laboratory standards.

• Developed strategic approaches to areas of concerns indicated by CQI committee investigations, while also routinely evaluating that planned interventions are implemented and goals are met per CAPA.

• Ensure appropriate therapeutic use of antipsychotic medication. Ensure nursing staff accurately update data tools required for unit manager and pharmacy consultant review during the behavior management process.

• Therapeutic data review for accuracy and effectiveness of therapies with physicians, dieticians, nurse practitioners, and patients monthly or quarterly (depending on type of therapy).

• Routine monitoring of infection control standards, monitoring tools, and or issues presented by nursing services. Develop interventions that will result in outcomes beneficial to patient and facility per CAPA. August 2002 – May 2007

Charge Nurse (LVN) Villa Rancho Bernardo Health Care San Diego, CA Responsible for delivering quality patient-centered, care. A dedicated member of multidisciplinary healthcare teams known for excellent clinical skills; ability to remain calm under pressure; and strengths in making swift, correct decisions in emergency situations. Provided nursing care to patients with acute and chronic illnesses ranging from cardio-vascular incidents (cardiac arrest/strokes) traumatic injury, general and geriatric psychiatric issues, drug dependency, and other chronic health issues

• Displayed expert clinical skills in managing the care of all categories of patients.

• Demonstrating sound decision-making that helped save patient lives.

• Supervised other LPNs and CNAs and served as a preceptor/mentor to new nurses.

• Served as a nursing representative on multiple committees including Medication Safety Committee, Nurse Recruitment Committee and JCAHO Readiness Taskforce.

• Contributed to strategic plans and initiatives to advance standards of care excellence, improve patient outcomes and drive continuous improvement.

• Patient and or family education with documented referrals to other necessary agency support when needed.

Page 2 of 4

References Available Upon Request

Kimberly M. Swint

email: acuj4o@r.postjobfree.com cell: 858-***-****

• Ensure compliance with all operating policies and procedures and CA Department of Health regulations and Federal Health Care Administration regulations

• Communicate with and supervise appropriate personnel

• Provide daily reports and other periodic reports January 1999 – June 2005

Health Technician Escondido Union School District Escondido, CA

• Performed specialized physical health care for pupils that require medically related training.

• Assisted in the administration of prescribed medication, including emergency glucagon and epinephrine auto-injections; assist in positioning pupils for health care and/or medication administration.

• Assisted in a variety of health screening programs.

• Performed receptionist duties in the school health office; maintained electronic and paper health and immunization records; typed correspondence, reports, health record cards, and information bulletins; requisition supplies; maintained inventory records and distribute first aid materials to classrooms. August 1992 – August 1998

Hemodialysis Nurse Helene Fuld Medical Center Trenton, NJ

• Reviewed patient data and made appropriate adjustments/modifications to the treatment plan when necessary.

• Developing and maintaining effective relationships with patients and families

• Demonstrated the ability to continuously administer high quality safe and effective life- prolonging care for patients undergoing Hemodialysis Therapy in accordance with facilities policies and procedures.

• Strong commitment to maximizing patient/family satisfaction through the delivery of passionate care and conducting ongoing education in a specialized care environment.

• Supported, medicated, and monitored patients throughout hemodialysis, other renal replacement therapeutic services as well as educate them on kidney disease and help them to manage their disease.

• Provided preoperative and postoperative nursing care for patients admitted for medical-surgical services in a hospital setting.

SKILLS

• Good Clinical Practices knowledge.

• Microsoft Applications: Word, Office, Excel, Project

• SOP Development

• SharePoint

• File Transfer Protocol (FTP), Drop Box

TRAINING

• Drug Information Association (DIA) Drug Safety Program

• DIA Chemistry, Manufacturing, and Controls for Drug and IND Development

• Clinical Research Associate (CRA) On-boarding 10-week course CERTIFICATIONS

• IV Certified since 2003

Page 3 of 4

References Available Upon Request

Kimberly M. Swint

email: acuj4o@r.postjobfree.com cell: 858-***-****

• BCLS Certification

• Current State of California Vocational Nursing License

• GCP Certified (Good Clinical Practice)

EDUCATION

Attending Ashford University Clinton, Iowa

Bachelor of Arts in Health Care Administration, Minor in Public Health 1991 Mercer County Technical School Hamilton, NJ

License Practical Nursing Program

Professional Affiliations

Drug Information Association (DIA), member since April 2014 National Black Nurses Association (NBNA), since August 2015 Page 4 of 4

References Available Upon Request

Contact this candidate