Senior Clinical Research Coordinator

OVERVIEWThis role will coordinate research in an exciting new environment, with the full backing of a new type of research architecture and a top-tier technology team, challenging the paper-heavy, old-school way that studies are run. This role will require the desire to learn and grow rapidly, and include the opportunity to help spearhead on-site efforts for Topography’s partner healthcare groups. This role will be evaluated on provider success, patient experience, protocol management and adherence, and data quality. This role will require a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers. You will need to be able to thrive with multiple balls in the air, and where independent problem solving is a daily need. You will need to lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country.KEY RESPONSIBILITIESAct as senior study coordinator to execute trials conducted within physician practices, including but not limited to:a. Visit preparation activitiesb. Visit follow-up activitiesc. Supply and inventory managementd. Third party vendor managementConduct patient recruitment and enrollment of eligible patients.Lead patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc. 4. Independently administer the informed consent process with care and quality 5. Ensure protocol adherence and high data integrityProvide high quality source data capture and documentationSupport study start-up and planning, including PSVs and SIVsSupport IRB submission and correspondenceFacilitate monitoring visits (IMVs) and sponsor correspondence including managing the follow-up processIP management, dispensation and accountabilityAdverse Event management, tracking, and follow-upData entry to CRF/EDC and query resolution in a timely mannerSupport study close-out, including COVsProtocol deviation tracking, reporting, and reconciliationTrain and mentor junior research staffUsing and helping improve Topography’s proprietary tool setData Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPsEnsure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentationConduct Quality Control activities including routine QC checks during and following study visitsAny other duties assigned by managerMINIMUM QUALIFICATIONSBachelor's degree or equivalent combination of training and experience5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role5+ years of experience independently coordinating studies, from study startup to close out5+ years demonstrated track record of delivering clean data and a high-quality patient experienceExpert knowledge of FDA regulations and ICH/GCP guidelinesStrong communication skills, teamwork, cooperation, self-awareness, and flexibility

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