CRA II (440083)
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POST DATE 9/15/2016
END DATE 10/14/2016
Murray Hill, NJ
JOB DESCRIPTIONJob Description:
OVERVIEW: Mid-level clinical trial monitoring position within Corporate Clinical Affairs Operations Group. The CRA II supports the day to day operations associated with the execution of clinical trials. The primary objective and purpose of this position is to ensure the overall quality of clinical trials by monitoring study data and managing site adherence to the protocol, GCP, all applicable regulations and related study documents. The CRA II is the primary contact with the study site and serves as the liaison between clinical investigators and Client. The CRA II is responsible for site training, regulatory document collection, tracking enrollment, and ensuring case report forms are accurate, complete and verifiable against source documents. The CRA II will monitor multiple clinical trial sites and studies. The CRA II is expected to contribute to the development and improvement of company procedures, processes, and templates in support of Client s efforts towards continuous quality improvement. Essential Job Functions: Ability to autonomously prioritize workload to meet study timelines while monitoring multiple protocols Perform monitoring visits: Qualify potential investigative site, Train and initiate investigative sites, Conduct routine monitoring visits and close out visits Complete on-time and thorough monitoring trip reports Review case report forms to ensure data compliance Account for investigational devices ensuring the devices are available, stored appropriately, and accurately inventoried and documented Verify appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements Ensure site regulatory binder is current Manage investigative sites from study start up through close out Provide support to the investigator evaluation and recruitment process Create telephone scripts, feasibility questionnaires, and / or other related assessment tools for use in site evaluation Assist in the collection of initial regulatory documentation Assist in the preparation of study binders, manuals, or other site specific tools Assist in the review of draft protocols, CRFs, and CRF Completion Instructions Assists in the creation and / or revision of Clinical Affairs Standards and Work Instructions: Develop study specific monitoring tools Perform study tracking activities as requested Assist in Development of Clinical Monitoring Plan and / or other study related documents Contribute to internal CRA meetings Proactively identify issues which may interfere with study progress and implement strategies to resolve issues Demonstrate strong problem solving skills Basic Qualifications Required: Education and/ or Experience Required: BS / BA in a related scientific area Basic knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment Minimum of 3-6 years of field monitoring experience Medical device experience preferred, but not required Proficient in MS Office Suite of products Experience with Clinical Trial Management System preferred Experience with EDC system preferred Excellent interpersonal and communication skills Additional Desirable Qualifications Skills and Knowledge: Current Certification (CCRA) through ACRPLocation: Remote Based
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