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Job #03209

About our client Our client is a successful division of a world leading medical device company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. The company has some of the strongest financial indicators in the industry, an experienced management team and a robust pipeline. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Support the day-to-day operations associated with the execution of clinical trials 2) Monitor multiple clinical trial sites and studies 3) Ensure the overall quality of clinical trials by monitoring study data and managing site adherence to the protocol, GCPs, all applicable regulations as well as related study documents 4) Act as the primary contact with the study site and liaise with clinical investigators and the company 5) Oversee site training, regulatory document collection, tracking enrollment and ensure CRFs are accurate, complete and verifiable against source documents 6) Contribute to the development and improvement of company procedures, processes and templates in support of company's efforts towards continuous quality improvement 7) Support the Investigator evaluation and recruitment process 8) Create phone scripts, questionnaires and other assessment tools for use in the selection of sites 9) Assist team in the development of site recruitment and retention strategy 10) Initiate contact with PIs, conduct pre-visits, assess potential investigators and recommend suitability of the site 11) Assist the Clinical Team with study start-up activities 12) Assist in development of protocol/ICF/CRF or CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals as well as other site specific and monitoring tools 13) Request and collect initial regulatory documentation 14) Ensure that sites fulfill their regulatory obligations as well as submit study documents for IRB review and approval 15) Perform study tracking and advise PM when an investigational site is approved and ready to receive investigational device supplies 16) Oversee site management and study execution activities 17) Plan and conduct training/site initiation, interim and closeout visits 18) Complete timely and accurate trip reports 19) Assess and ensure that investigational devices are available, appropriately used, handled correctly, stored and accurately inventoried as well as documented 20) Follow up with the site regarding timely completion and retrieval of CRFs and data correction forms 21) Assist sites to resolve regulatory document issues 22) Ensure adequate study and regulatory documentation is maintained at both the Investigator site and within the company 23) Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment 24) Document and report non-compliance in a timely manner 25) Identify areas requiring follow-up and improvement at each clinical site, recommend corrective action and or conduct site re-training as needed 26) Communicate findings from contact reports and monitoring visits to CRA Manager and PM in a timely manner Requirements 1) RN with BS/BA or higher degree in a related scientific area preferred 2) 3+ years of experience in medical devices or pharma field monitoring where travel was at least 50% 3) Experience in medical devices preferred 4) Willingness to domestic travel (up to 50%) across the US and ability to work in office when not on the road