Topography is challenging the paper-heavy, old-school way that studies are run by implementing a new type of research architecture and a top-tier technology team.
Requirements
- Expert knowledge of FDA regulations and ICH/GCP guidelines
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.
- 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
- Using and helping improve Topography’s proprietary tool set
Other
- 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
- Strong communication skills, teamwork, cooperation, self-awareness, and flexibility
