Challenging the paper-heavy, old-school way that studies are run by coordinating research in a new environment with a new research architecture and a top-tier technology team.
Requirements
- 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
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
- Data entry to CRF/EDC and query resolution in a timely manner
Other
- Bachelor's degree or equivalent combination of training and experience
- Desire to learn and grow rapidly
- Opportunity to help spearhead on-site efforts for Topography’s partner healthcare groups
- Thrive with multiple balls in the air, and where independent problem solving is a daily need
- Lead with empathy for patients, and care deeply about creating new access to clinical research in communities across the country
