Virginia iSpine Physicians, PC is a growing independent procedural based Interventional Spine practice in Richmond, Virginia. Our practice is looking for a smart, compassionate patient driven Clinical Research Coordinator to lead our busy clinical research department. Virginia iSpine Physicians, PC is one of the few premier medical subspecialty practices in the country engaged in cutting edge clinical research involving innovative technologies for painful spine and musculoskeletal conditions. A competitive candidate will be dependable, have strong communication skills, be precise and focused on attention to detail, have the ability to manage deliverable timelines and have strong initiative. Under direct supervision of Principal Investigator, the Clinical Research Coordinator will: · Complete training requirements including study specific training modules · Expertly manage multiple ongoing active phase 2-4 clinical trials · Have in depth knowledge of all of our active studies, will educate subjects on protocols related to the procedures and explain/answer questions pertaining to informed consents specific to the study protocols to potential enrollees · Actively recruit potential study candidates including addressing incoming calls from study marketing campaigns to schedule prescreening/ screening visits for increased enrollment · Conduct screening and recruitment of subjects for research trials using knowledge of current protocols and inclusion/exclusion criteria to determine patient eligibility · Collect, organize, and maintain data and test results for source documentation of all research subjects · Work closely with our physicians in fellowship training in monitoring study subjects' health status during the course of the research trial · Conduct required assessments using protocols for review by the principal investigator when appropriate · Complete visit procedures according to protocol schedules including obtaining/reviewing required visit measurements, lab results, concomitant medications, and occurrence of any adverse events · Draw blood when needed, as well as process and ship specimens according to sponsor requirements · Keep accurate records of temperature logs of study drugs in storage and freezers, along with other miscellaneous tasks · Work closely with sponsor monitors during site initiation visits, site monitoring visits and answer queries when needed · Assist with sponsor contract and budget negotiations and maintain the research invoicing system for each study · Enter completed charting data in EDC for respective studies · Complete study close-out visits including review of drug accountability and shipment of used and unused study medications
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· Bachelor’s degree preferred · Current GCP training via CITI required · Medical background or training is a plus · Preferably SOCRA or ACRP certified. If not, successful applicant will be required to complete this certification within the first year of hire. · Well versed and familiar with all aspects of FDA regulated studies. |
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