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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 senior study coordinator to execute trials conducted within physician practices, including but not limited to:
a. Visit preparation activities
b. Visit follow-up activities
c. Supply and inventory management
d. Third party vendor management
Conduct 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 integrity
Provide high quality source data capture and documentation
Support study start-up and planning, including PSVs and SIVs
Support IRB submission and correspondence
Facilitate monitoring visits (IMVs) and sponsor correspondence including 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
Support study close-out, including COVs
Protocol deviation tracking, reporting, and reconciliation
Train and mentor junior research staff
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
Conduct 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
Ability to be on site 5 days a week in Chevy Chase, MD
5+ years of experience as a Clinical Research Coordinator, Research Assistant, or other similar role
5+ years of experience independently coordinating studies, from study startup to close out
5+ years demonstrated track record of delivering clean data and a high-quality patient experience
Expert knowledge of FDA regulations and ICH/GCP guidelines
Strong communication skills, teamwork, cooperation, self-awareness, and flexibility
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