Clinical Research Manager Oversees administration of department-based Clinical Research Program.Assist in development, implementation and administration of policies and procedures.•Oversee day to day operations of research office, hiring and training new research staff. •Responsible for conducting pharmaceutical and device studies according to GCP and ICH guidelines. Maintain essential documents binder, Identify and recruit patients for appropriate studies.•Monitor and evaluate patients involved in research studies, including patient’s response to therapy, and adverse events, reports AE’s and SAE to appropriate agencies.•Adhere to protocol in scheduling of study visits, test and procedures.•Performs study related procedures with skill and knowledge including but not limited to the collection and processing of specimens, ECG, venipuncture and IV access, exams, and drug dispensing.•Receive IP from sponsor confirms receipt per IVRS, Maintain accurate logs for drug dispensing and accountability. Keep accurate temperature log for drugs and specimen storage.• Accurate data collection and documentation on source documents and CRF and eCRFs•Perform informed consent process by allowing adequate time for subject to read consent and ask questions. Assuring no procedures are preformed before the consent is signed. •IRB submissions, negotiates contracts and budgets, work closely with sponsors to obtain approval. Schedule on site monitoring visits and assist as need. Attend investigator meetings. In addition, attend IRB meetings.

R.N. CLINICAL RESEARCH COORDINATOR 07/2005 to 01/2007•Implemented study protocols and recruited patients for studies•Identified and screened suitable patients for trials •Informed consent process•Managed day to day operation of assigned studies•Scheduled patients and monitoring visits•Drug accountability, regulatory agency compliance, IRB and SAE reporting, completed patient assessments, collected data and drawing and processing blood samples