OVERVIEW

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, 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 RESPONSIBILITIES

Act as study coordinator to execute trials conducted within physician practices, including but not limited to:

Visit preparation activities

Visit follow-up activities

Supply and inventory management

Third party vendor coordination

Conduct patient recruitment and enrollment of eligible patients

Conduct patient study visits, which may also include clinical and lab procedures such as ECG, phlebotomy, vitals signs and body measurements, laboratory processing, etc.

Independently administer the informed consent process with care and quality

Ensure protocol adherence and high data integrity

Provide high quality source data capture and documentation

Attend study start-up and planning meetings, including PSVs and SIVs 8. Facilitating monitoring visits (IMVs) and sponsor correspondence including assisting with follow-up items

IP management, dispensation and accountability

Adverse Event management, tracking, and follow-up

Data entry to CRF/EDC and query resolution in a timely manner

Support study close-out, including COVs

Protocol deviation tracking, reporting, and reconciliation

Using and helping improve Topography’s proprietary tool set

Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research, including our SOPs

Ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation

Assist in Quality Control activities including routine QC checks during and following study visits

Any other duties assigned by manager

MINIMUM QUALIFICATIONS

Bachelor's degree or equivalent combination of training and experience

3+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role

3+ years of experience independently coordinating studies, from study startup to close out

3+ years of a demonstrated track record of delivering clean data and a high-quality patient experience 2+ years expert knowledge of FDA regulations and ICH/GCP guidelines

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