The 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.

Key responsibilities include: Acting as senior study coordinator to execute trials conducted within physician practices, Conducting patient recruitment and enrollment of eligible patients, Leading patient study visits, which may also include clinical and lab procedures, Independently administering the informed consent process with care and quality, Ensuring protocol adherence and high data integrity, Providing high quality source data capture and documentation, Supporting study start-up and planning, including PSVs and SIVs, Facilitating monitoring visits (IMVs) and sponsor correspondence, Managing the follow-up process, IP management, dispensation and accountability, Adverse Event management, tracking, and follow-up, Data entry to CRF/EDC and query resolution in a timely manner, Supporting study close-out, including COVs, Protocol deviation tracking, reporting, and reconciliation, Training and mentoring junior research staff, Using and helping improve Topography’s proprietary tool set, Understanding and complying with all regulations, policies, and guidelines applicable to clinical research, including our SOPs, Ensuring adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation, Conducting Quality Control activities including routine QC checks during and following study visits, Any other duties assigned by manager.

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Key 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.

The 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.

This 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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