This 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.
\nThe ideal candidate will have a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers.
\nKey responsibilities include:\nActing as senior study coordinator to execute trials conducted within physician practices,\nConducting patient recruitment and enrollment of eligible patients,\nLeading patient study visits, which may also include clinical and lab procedures,\nIndependently administering the informed consent process with care and quality,\nEnsuring protocol adherence and high data integrity,\nProviding high quality source data capture and documentation,\nSupporting study start-up and planning, including PSVs and SIVs,\nFacilitating monitoring visits (IMVs) and sponsor correspondence,\nManaging the follow-up process,\nIP management, dispensation and accountability,\nAdverse Event management, tracking, and follow-up,\nData entry to CRF/EDC and query resolution in a timely manner,\nSupporting study close-out, including COVs,\nProtocol deviation tracking, reporting, and reconciliation,\nTraining and mentoring junior research staff,\nUsing and helping improve Topography’s proprietary tool set,\nUnderstanding and complying with all regulations, policies, and guidelines applicable to clinical research, including our SOPs,\nEnsuring adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation,\nConducting Quality Control activities including routine QC checks during and following study visits,\nAny other duties assigned by manager.
\nXML job scraping automation by YubHub
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\nKey responsibilities include acting as a research assistant to clinical trials conducted within physician practices, visit preparation activities, visit follow-up activities, supply and inventory coordination, third-party vendor coordination, patient recruitment and identification, and assisting with patient study visits.
\nThe ideal candidate will have a high school diploma or equivalent, knowledge of FDA regulations and ICH/GCP guidelines, and the ability to draw blood, run labs, and take vitals. Strong communication skills, teamwork, cooperation, self-awareness, and flexibility are also required.
\nThis role will be evaluated on patient experience, protocol management and adherence, and data quality. The successful candidate will lead with empathy for patients and care deeply about creating new access to clinical research in communities across the country.
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