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Job #03628

About our client Our client specializes in medical devices for patient care. Position Location Senior CRA New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Support the investigator evaluation and recruitment process 2) Create phone scripts, questionnaires and other assessment tools for use in the selection of sites 3) Assist the team in developing site recruitment and retention strategy 4) Initiate contact with PIs, conduct pre-visits, assess potential investigators and recommend suitability of the site 5) Assist Clinical Team with study start-up activities 6) Help in developing protocol/ICF/CRF/CRF completion guidelines, preparation and maintenance of monitoring plans 7) Assist in developing study binders study manuals, and other site specific and monitoring tools 8) Request and collect initial regulatory documentation 9) Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval 10) Perform study tracking and advise PM when an investigational site is approved and ready to receive investigational device supplies 11) Conduct site management and study execution activities 12) Plan and conduct training/site initiation, interim and close-out visits as well as complete timely and accurate trip reports 13) Assess and monitor that investigational devices are available, appropriately used, handled correctly, stored and accurately inventoried and documented 14) Follow up with the site regarding timely completion and retrieval of CRFs and data correction forms 15) Assist sites to resolve regulatory document issues 16) Ensure that adequate study and regulatory documentation is maintained at both the Investigator site and in-house 17) Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment 18) Document and report non-compliance in a timely manner 19) Identify areas requiring follow-up and improvement at each clinical site and recommend corrective action and or conduct site re-training as needed 20) Communicate findings from contact reports and monitor visits to CRA Manager and PM in a timely manner Requirements 1) BS/BA or higher in a related scientific area 2) RN certification 2) Minimum 3 years of related device/pharmaceutical field monitoring experience 3) Willingness to travel (up to 50%)