Clinical Research Associate II

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POST DATE 9/8/2016
END DATE 10/9/2016

Seattle Genetics, Inc. Bothell, WA

Company
Seattle Genetics, Inc.
Job Classification
Full Time
Company Ref #
360712
AJE Ref #
576116182
Location
Bothell, WA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Summary: /span /span /p p span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Responsible for supporting study and site management. This position focuses on coordination of all activities required to evaluate, initiate, monitor and close clinical trial sites, as well as assisting with the preparation and review of study documents and plans, and review and analysis of clinical data for use in reports. /span /span /p p span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Responsibilities: /span /span /p ul li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist with development / review of study documents, which may include clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist with the review and analysis of clinical data for clinical trial report generation. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Act as one of the primary contacts between Seattle Genetics, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites. Maintain close contact with clinical trial sites. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Instruct clinical investigators and their personnel in regard to clinical trial protocol regulatory requirements, and with clinical trial specific training. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Travel alone or with CRO representative to clinical trial sites to monitor compliance with the clinical trial protocol, CFR, GCP/ICH regulations, and overall protocol objectives. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-out phase of any clinical trial study. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" May perform routine clinical trial site monitoring functions: /span /span ul li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Monitor compliance with study protocol, CFR, GCP/ICH and overall clinical objectives. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Verify adequacy of clinical data through comparison of case report forms to source documents. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Perform drug accountability and ensure adequate drug supply. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Review and authorize research specimen sample shipments to central lab. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Collaborate with Drug Safety Group to ensure that study staff complies with the serious adverse event reporting requirements. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist with management of clinical trial supplies. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" On-going review of site regulatory file for completeness and accuracy. Ensure clinical trial site training records are current and maintained as required /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan. /span /span /li /ul /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" May assist in the preparation and follow-up of in-house and on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" May coordinate project meetings and assist in the support or maintenance of clinical trial timelines /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist in the maintenance of the Clinical Trial Master System and Trial Master file /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Ensure appropriate CRF completion and adequacy of clinical trial site monitoring. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist with management of research specimen samples. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist with management of clinical trial site monitoring staff activities including review and approval of clinical trial site monitoring reports. /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Assist with review and approval of clinical trial related invoices /span /span /li li span style="font-size:14px;" span style="font-family:verdana,geneva,sans-serif;" Maintain familiarity with new developments in clinical literature. Demonstrate increased ability to discuss scientific, medical and therapeutic area