Topography is looking to solve the problem of paper-heavy, old-school clinical research studies by implementing a new research architecture and technology team, and this role will help coordinate research in this new environment.
Requirements
- Expert knowledge of FDA regulations and ICH/GCP guidelines
- Ability to use and help improve Topography’s proprietary tool set
- Data Quality-understand and comply with all regulations, policies, and guidelines applicable to clinical research
- Ability to conduct Quality Control activities including routine QC checks during and following study visits
- Ability to ensure adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation
Responsibilities
- Act as senior study coordinator to execute trials conducted within physician practices
- Conduct patient recruitment and enrollment of eligible patients
- Lead patient study visits, which may also include clinical and lab procedures
- 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
- Data entry to CRF/EDC and query resolution in a timely manner
Other
- 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
- Strong communication skills, teamwork, cooperation, self-awareness, and flexibility
- Ability to thrive with multiple tasks and independent problem solving
