jessica claire montgomery street san francisco ca 94105 555 4321000 resumesampleexamplecom summary dedicated responsible site management associate 8 years experience clinical research industry including cro site roles successful collaborator competent managing complex research projects fastpaced work environment wellorganized approaching problems investigate causes determine optimal solutions detailed understanding organizational regulatory expectations drive performance proficient microsoft office word excel outlook powerpoint well clinical trial softwares including veeva vault phlexview etmf3 pso ctms edc systems guest services inventory control procedures merchandising expertise skills loss prevention cash register operations product promotions experience site management associate ii 102021 current abbott laboratories portsmouth nh achieve successful delivery site startup inhouse site management closeout activities meeting internal external client requirements work closely sites study team members coordinate collection review essential documents accordance applicable sponsor icon standard operating procedures sops ichgcp guidelines applicable regulatory requirements manage submission amended protocol level documents protocol ib icf patient materials subject recruitment materials continuing review documents proactively work site answer queries including related vendor data follow query aging issuing queries well missing pages needed based cracma review performs documents clinical data review query creation query resolution offsite central monitoring contactsvisits site management communications outlined study plans andor processes act liaison clinical supplyservice vendors functional area team members meet project team goals participate creation maintenance clinical project documents including limited clinical management plans monitoring guidelines site operations manuals monitoring visit letter templates project determine tracks reviews milestones tasks timelines project hours clinical activities assigned projects ensuring adherence contract budget provide timely status reports clinical activities assigned projects ensure tasks meet sponsor pra expectations delivered accordance contract trial protocol ichgcp applicable sops provide data required clinical operations performance metrics project status metrics clinical trial specialist ii 032018 062020 talis biomedical concord ca perform investigator recruitment activities utilizing phone scripts questionnaires study site materials tools use evaluating investigative sites perform essential document collection review maintenance closeout activities ensuring sponsor investigator obligations met compliance applicable local regulatory requirements ichgcp guidelines support investigators site staff fulfilling obligations regard local submissions according local regulatory institution review board irbindependent ethics committee iec requirements perform study duties adherence protocol clinical management plan cmp study processes ichgcp requirements stipulated study follow sites trial invoices ensure ctms accurately updated allow timely processing investigator payments determine track review milestones tasks timelines project hours clinical activities assigned projects ensuring adherence contract budget act liaison clinical supplyservice vendors functional area team members meet project team goals clinical trial assistant 012016 032018 stanford school medicine stanford ca assist clinical project managers cpms clinical research associates cras accurately updating maintaining clinical systems track site compliance performance within project timelines assist clinical team preparation handling distribution filing archiving clinical documentation reports according scope work standard operating procedures assist periodic review trial master files accuracy completeness assist cpms preparation handling distribution clinical trial supplies maintenance tracking information act central contact clinical team designated project communications correspondence associated documentation lead clinical research coordinator 112013 012016 clinical research consultants city state recruit instruct monitor patients appropriate specific study objectives plan coordinate initiation clinical trials accordance applicable study protocol ichgcpfdairb ohrp guidelines maintain safety confidentiality research patients collect process shipp blood samples managing drugs supplies inventory record update data clinical research forms electronic data collection systems education training masters degree environmental science university sciences cadi ayyad marrakech morocco bachelors degree biology university sciences cadi ayyad marrakechmorocco accomplishments ich gcp e6 training program introduction principles ich gcp ich gcp annual refresher subject rights ich gcp e6 training program sponsor monitoring auditing noncompliance ich gcp e6r2 training program clinical trial protocol investigators brochure institutional review boards independent ethics committees gcp serious breach identify notify potential gcp serious breach query writing query resolution good documentation practices configuration monitoring reporting protocol deviations managing informed consent forms clinical trial regulatory documents collection review approval maintenance guidance notification serious breaches gcp clinical trial protocol patient safety medical ethics biomedical research basic course citi program managing import export clinical trial supplies distribution tracking safety reports investigators irbiecs management project documentsmaterials translations