Seattle Women's Clinical Research Center Work Values

Daily Duties at Seattle Women's Clinical Research Center:

Seattle Women’s: Health, Research and Gynecology July 2006 - Jun 2011 Seattle, WA Accomplishments: • Five years of experience in managing multiple studies simultaneously, while utilizing excellent organiz- ational skills/critical thinking skills and good judgment, consistently able to provide high level of performance. • Ability to coordinate clinical trials in different phases( II-IV) from incipient stages to completion. • Attended Investigator meetings • Participated in on-site training, thereby ensuring high quality in the research setting. • Collaborated with Principal investigator in determining eligibility of potential participants and enrolled participants. • Ensured timely and accurate documentation of collected data into the different sponsor’s electronic data platforms (Oracle, Inform, RDC, e-caselink, etc…) • Managed Drug/Device accountability with the outcome of reconciling drug/device accountability to the actual amount on site. •Provided invaluable education to study participants on proper use/intake of investigational device/ medication to avoid errors in data collection and ensure the well-being of study participants. •Facilitated scheduling of monitoring activities and actively participated in them, so sponsor’s were aware in real time of the data being collected. • Followed HIPPA compliance; ensuring protection of personal medical information. •Followed-through: Ensured that the research conducted was in compliance with Standard Operating procedures (SOP’s), Good Clinical Practices (GCP) and FDA/ICH guidelines ensuring quality of the coll- ected data. • Experienced at consulting with recruitment coordinator to uncover the advertisement needs of studies and propose a recruitment plan to sponsors and ethical committees. • Implemented new studies: creation and submission of regulatory documents (eg; 1572s, Financial disclosure forms, Certificate Trial Agreements, creation of source documents) for sponsor’s and Ethical committees, thereby ensuring prompt start of projects which saved time and financial resources. •Interacted with people of all ages, educational and socio economic backgrounds by presenting studies in detail ensuring proper inform consent collection. •Maintained studies by through continuing review with Principal Investigator of any change in a participant’s medical history, adverse events, concomitant medication use, serious adverse events or any other arising problem. •Maintained regulatory documents following Standard Operating Procedures and IGH/GHP guidelines preventing any problems in the future. •Managed all details that involve closing a study: All drug/device logs reconciled, destruction of any Study medication, all data successfully collected, reporting to the ethical committee of study closure; Guaranteeing successful filing and archiving of study trial file. •Successful at performing various clinical procedures, thereby verifying quality in data collected: Vital sign collection, phlebotomy, electrocardiograms, anthropometrics, uroflows, urine pregnancy tests, lab processing and shipment, urinalysis, occult blood tests, temperature, assisted in various medical procedures: skin biopsies, Intra uterine device placements/removals, colposcopies, LEEP (Loop Electrical Excision Procedure) •Ordered and maintained study laboratory supplies. •Guided and instructed clinical staff of data being collected.

What they like about Seattle Women's Clinical Research Center:

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Tags

Bilingual: English-Spanish, Strong analytical and conceptual skills, Critical Judgement, Problem Solving, strong work ethic, reliability, integrity and team work, detail- oriented, time management prioritization, multiple task/coordination skills, Solid FDA/ICH, GCP guidelines, focused, inquisitive, resourceful, Word, Power Point, Excel, Outlook, personable

Skills

Experience with managing multipe studies simultaneously, Ensured timely and accurate documentation of collected data into the different sponsor’s electronic data platforms., Provided invaluable education to study participants on proper use/intake of investigational device/medication, Successful at Performing various clinical procedures, therefore ensuring quality in data collected., Ensured that the research conducted was in compliance with Standard Operating procedures (SOP’s) ,Good Clinical Practices (GCP) and FDA/IHC guidelines

These are some of the questions we asked our climbers about their experiences with Seattle Women's Clinical Research Center: