jessica claire 9 resumesampleexamplecom 555 4321000 montgomery street san francisco ca 94105 professional overview highly motivated sales associate extensive customer service sales experience outgoing sales professional track record driving increased sales improving buying experience elevating company profile target market core qualifications guest services inventory control procedures merchandising expertise loss prevention cash register operations product promotions education pennsylvania state university 1993 bs psychology psychology experience drug information association inc education compliance coordinator champaign il 072009 current performs routine monitoring oncology clinical trials conducted investigatorsponsored investigational new drug ind applications university pittsburgh cancer institute responsible performing quality assurance audits research protocols throughout university pittsburgh organizes participates educational programs related human subject research maintains disseminates uptodate information regarding federal regulations ethical considerations irb policies related use human subjects research apex systems clinical research associate fairfield ia 122007 072009 contract cra i3 pharma resourcing respironics inc transitioned fulltime employee respironics inc september 2008 develops clinical protocols product investigator brochures study informed consent documents supports regulatory submissions assigned business unit prepares requests proposals rfps negotiates budgets agreements planned clinical trials organizes product design reviews preparation release investigational devices monitors activities clinical sites assure adherence good clinical practices gcps us food drug administration fda regulations study protocol reviews regulatory documents maintains sponsor regulatory binder prepares site visit reports assists site initiation visits ongoing training study closure ensures timely identification reporting adverse events according fda guidelines standard operating procedures covance regulatory specialist cranford nj 092007 122007 developed clinical study protocols regulatory submissions various scientific medical related reports contribute overall clinical regulatory effort oncology trials prepared submitted ind applications amendments annual reports sae reports fda created submitted scientific reports regarding trial progress sae reports protocol status change updates termination reports university pittsburgh institutional review board irb regulatory committees per guidelines maintained organized assessable regulatory file site auditmonitoring visits per upci policies maintained upci clinical trials management system ctms database m3 global research project coordinator cleveland oh 042002 092007 prepared protocols informed consent documents ensured staff faculty compliance federal local human subject regulations developed registry protocols dna collection analysis subject recruitment monitored existing projects compliance managed multisite protocols regulatory compliance including oversight data safety monitoring boards acted liaison investigators irb staff resolve human subject issues normandale community college program manager clinical research coordinator bloomington mn 081998 022002 coordinated 25 phase iiiv clinical drug trials psychiatric indications inpatient outpatient populations promoted program manager october 2002 program manager supervised junior clinical research coordinators ensured execution clinical research protocols according irb policy fda regulations good clinical practices gcps prepared negotiated budgets sponsor representatives authored literature review publications anxiety disorders danaher clinical research coordinator charlotte nc 101996 081998 coordinated twoyear phase iii study examining efficacy sertraline adults co morbid depression alcohol dependence mercy behavioral health system counselor city state 031997 061998 worked parttime counselor residential facility served clients mental illness developmental disabilities university pittsburgh medical center upmc western psychiatric institute clinic wpic research associate city state 031994 011996 investigated biobehavioral development female adolescents substance abuse psychiatric disorders administered structured diagnostic interviews standardized neuropsychiatric testing fellowships awards publications claire cm rapaport mh anxiety disorders 2001 dl dunner jf rosenbaum eds psychiatric clinics north america annual drug therapy philadelphia wb sunders 181208 rapaport mh claire c panic disorder 2001 current psychiatry reports 3 295301 presentations membershipsscholarly societies skills binder brochures budgets counselor clients database product design ind monitors policies progress proposals protocols publications quality assurance recruitment reporting research safety scientific structured annual reports