Clinical Research Manager, Clinical Research

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CONTACT INFORMATION 1802 E. McGraw Street Seattle, WA 98112 Tele: (206) 941-8871 E-mail: WORK EXPERIENCE University of Washington January 2008-September 2010 Seattle, WA Research Manager Managed and directed clinical research staff in study operations for clinical tr ials and observational outcomes research in the General Surgery Division at the Department of Surgery. Project management experience included effectively monito ring customer feedback at multiple hospitals, Human Subjects divisions, Principa l Investigators, medical staff/mid-level providers, physicians, sponsors, Nation al Institutes of Health, and Data Coordinating Center while serving as an active liaison for multiple hospitals and staff. Supervised and instructed research co ordinators, research assistants and student interns in the Department of Surgery . * Managed study budgets for staffing, recruitment, retention, supplies and equi pment needs. * Supervised and mentored research staff. * Maintained compliance with Institutional Review Board (IRB) regulations. * Completed medical and medication histories, blood pressure and pulse readings , height, weight and body measurements of patients. * Extracted technical, medical, laboratory and/or behavioral information from c linical records. * Collaborated with physicians, other clinicians and medical staff in the hospi tal setting. * Completed detail analysis of study budgets and directs staff on all operation al aspects of general surgery research studies. * Recruited, tracked and monitored human subject involvement on several surgica l-related studies. * Traveled to various clinical and research sites to ensure compliance of clini cal research studies. * Ensured all study visits at all sites have adequate staff to meet with subjec ts in order to maximize recruitment and retention efforts. * Responsible for regulatory compliance on all research studies across all site s. * Completed progress reports/proposals; assist in maintenance of study protocol s * Created and edited technical reports and manuscripts for publication and pres entation. * Developed and prepared grants and human subject materials. University of Washington March 2005-December 2008 Seattle, WA Research Coordinator Managed research efforts at several data collection sites including several high profile multi-center national clinical trials for obesity and surgery related N IH projects. Project management experience included building successful liaisons with funding sponsors, clinical research organizations, and clinicians in priva te practice, industry and various governmental agencies. * Assisted in developing research designs, data collection methods and strategi es for data management.

* Maintained compliance with Institutional Review Board (IRB) regulations. * Recruited, tracked, and monitored human subjects in several surgical-related studies. * Developed and maintained research databases and create system for data analys is. * Established and maintained working relationships with medical center staff to coordinate care for patients on research protocols. * Extracted technical, medical, laboratory and/or behavioral information from c linical records. * Created and edited technical reports and manuscripts for publication and pres entation. * Collected, prepared, and/or shipped specimens for laboratory analysis accordi ng to federal regulations. * Acted as liaison between project team and funding agency. * Ensured accuracy of data and participated in quality-control activities. University of Washington Seattle, WA Research Coordinator September 2003-March 2005 Managed all aspects of clinical trials including study initiation to project clo se-out procedures for a group of General Surgeons and an Orthopedic Surgeon incl uding: NIH-sponsored study of surgical intervention for necrotizing pancreatitis , industry-sponsored necrotizing pancreatitis antibiotic trial, investigator-ini tiated esophageal and pharyngeal impedance, Paraesophageal hernia repair, breast specimen repository, a chemotherapy study with ACOSOG (American College of Surg eons Oncology Group) for GastroIntestinal Stromal Tumor (GIST) and a total knee replacement and gastric bypass study. * Coordinated study activities, including correspondence with study sites, appl ications of IRB approval, and recruitment of study participants. * Completed and maintained compliance with IRB regulations for each study. * Developed and maintained research databases and creates system for data analy sis. * Participated in screening, consenting, and enrolling potential study patients according to Good Clinical Practice (GCP) standards. * Established and maintained working relationships with medical center staff to coordinate care for patients on research protocols. * Maintained contact with human subject participants and monitors human study i nvolvement. * Participated in budget preparation and negotiation with study sponsors. * Developed case report forms and data monitoring tools. * Created and modified informed consent forms per University of Washington guid elines. * Collected, prepared, and/or shipped specimens for laboratory analysis accordi ng to federal regulations. Puget Sound Blood Center, Seattle, WA Research Associate September 2002-September 2003 * Participated in all aspects of phase I clinical research for type I diabetes per study protocol, FDA, and cGMP regulations. * Performed data management in Good Laboratory Practices (GLP) environment: col lection, analysis, recording, and data entry for research study * Maintained and developed procedural SOPs and protocols. * Completed patient chart review. * Participated in all aspects of laboratory functions: * Performed microbiological and quality assurance testing. * Collected, processed and shipped study-specific laboratory specimens. * Trained research staff members. Puget Sound Blood Center, Seattle, WA

Laboratory Technologist January 2001-September 2002 * Performed serologic and component preparation procedures based on FDA require ments. * Verified patient identification and compatibility of pre-transfusion history, and blood component specifications. * Completed permanent patient transfusion records, billing documents, and other appropriate technical records. Water's Edge Natural Health Services, Seattle, WA Front Desk Receptionist October 1999-December 2000 * Scheduled patient appointments. * Released medical records. * Reconciled daily, weekly and monthly accounting transactions. * Prepared insurance claim requests. EDUCATION University of Washington, MEDEX Northwest Masters of Clinical Health Services, Physician Assistant Training Program- March 2010- current University of Washington, Seattle, WA, Clinical Trials Certificate Program-Certi ficate June 2005 Ohio University, Athens, OH, BS Degree, Biology, Minor- Psychology, August 1999 The Defiance College, Defiance, OH, Biology, 1994-1996 LICENSURES/CERTIFICATES Basic Life Support, AHA, 2010 - 2012 Association of Clinical Research Professionals (ACRP) Re-Certified, October 2009

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