Resumes
Sara J. Swartzendruber, MS, RN
Expertise
- Nineteen years experience providing clinical nursing care, with fifteen years in the hospital setting.
- Nine years experience in research-related positions, with four years in clinical research and five years in the regulatory field.
- Experience with writing portions of clinical sections for submissions, such as NDAs, INDs, Investigator's Brochures and product labels.
- Experience with compiling and summarizing IND and postmarketing safety surveillance, including adverse event data gathering and reporting.
Professional Experience
| Mar 2002 - Present | Clinical Specialist Salamandra, LLC, Bethesda, MD |
- Assist with the medical writing of portions of clinical sections (Integrated Summary of Safety, Integrated Summary of Efficacy) of NDAs, INDs, Investigator's Brochures and product labels for regulatory submissions.
- Assist in tabulating and summarizing IND and postmarketing safety surveillance, including adverse event data, and reporting.
- Provide oversight functions for serious adverse event tracing and reporting.
- Provide quality assurance support and editing for regulatory documents.
| June 1997- Present |
Staff Nurse (Flex Pool), General Surgery Unit Georgetown University Hospital, Washington D.C. |
- Provide nursing care to a wide variety of post-operative patients on general surgery unit.
- Provide oversight and comprehensive patient teaching to prevent post-operative complications.
- Assist with patients’ discharge planning and coordinate discharge teaching.
| Mar. 1993 - April 1997 |
Research Nurse, AIDS Clinical Trials Unit
Georgetown University Medical Center, Washington D.C. |
- Administered HIV/AIDS clinical trials, including vaccine, prophylaxis, pharmacokinetic and primary therapy trials.
- Coordinated all aspects of complex HIV research protocols, including screening and enrollment of subjects, assessment and monitoring of patients on various therapeutic regimens, data collection and documentation functions, and ensuring protocol and regulatory compliance.
- Served as primary liaison between patients, principal investigators, primary care physicians, pharmacists, phlebotomists, lab technicians, protocol specialists and site monitors.
- Attended numerous protocol start-up meetings and training sessions, and ACTG and HIV treatment conferences where preliminary and final protocol results were presented.
| Feb. 1988 - Feb. 1993 |
Staff Nurse, Medical – Surgical and Orthopedic Units |
- Provided primary nursing care to medical-surgical and orthopedic patients and coordinated patients’ discharge planning and teaching.
- Fulfilled charge nurse duties, oriented new staff members and served as staff mentor for nursing students.
Education
-
M.S. Nursing, Georgetown University, Washington D.C. (1993)
Specialty Area: Oncology and Immune Dysfunction -
B.S. Nursing, The Catholic University of America, Washington D.C. (1987) -
A.A. Business, Hesston College, Hesston, KS (1978)
Honors, Awards, and Certifications
- Current D.C. Nursing License #RN 53256
- AIDS Certified Registered Nurse, April 1996
- Poster Presentation entitled “HIV/AIDS Outpatients’ Perceptions of
Nurse Caring Behaviors, Association of Nurses in AIDS Care Conference, October 1993 - Master’s Comprehensive Exam Passed With Distinction, Georgetown University, 1993
- Dean’s List, The Catholic University of America, 1986, 1987