Susan Fitzsimmons Email & Phone Number

Pompano Beach, Fl, Us

Raleigh, North Carolina, Us

Brentford, Middlesex, Gb

Neurology, Oncology, Infectious Disease Group: Oncology FocusResponsible for monitoring Phase II-III clinical trials from site selection to study closure. Monitored breast cancer studies with additional studies in diabetes, psoriasis, and dyslipidemia.Worked closely with Medical Liaisons to identify diverse sites and determine effective patient recruitment strategies. Assisted with mentoring new contract CRAs Served as a resource person for GSK electronic tracking system (eTrack) for the SE RegionParticipated in the review of Standard Operating Procedures that involved Clinical Operations Member of the proof-of-concept ITP team which involved intensive monitoringUtilized both paper and electronic case report forms; trained in remote data management with Inform

Us

Responsible for development and management of a Clinical Quality Assurance department including CQA audits, Clinical Data audits, Computer validation audits, IND audits and other systems audits. Managed Trial Master Files and SOP system. Served as HIPPA compliance officer with legal department. Manager, Contract Clinical Monitors Mar. 1999 – Mar. 2000 Senior Manager, Clinical Auditing Jan. 1997 – Mar. 1999 Responsible for developing a system for clinical data auditing and reviewManager, Clinical Data Auditing Nov. 1993 – Jan. 1997Clinical Research Study Manager/Safety Associate Dec. 1992 – Nov. 1993

Responsible for monitoring the conduct of clinical trials in Florida, Puerto Rico and South Alabama. Area of focus was oncology-solid tumors and CML.

Start up of 24 bed in-house Clinical Research Unit for Phase 1 studies. Study Coordinator leading to Site Management of PK/PD studies. Assisted as RN in OTC product studies and employee health. Developed SOPs and trained new staff. Presented PK of oral antibiotic in elderly study at ICAAC meeting.

Boca Raton, Fl, Us

Registered nurse of Medical/Surgical floor and Diabetes/Dialysis floor. Certified Diabetic Nurse Educator. Served on Policy and Procedures committee.

Master'S Degree, M.S. Human Services / Healthcare Administration

Bs, Nursing