Topography is looking to solve the problem of the paper-heavy, old-school way that studies are run in the healthcare industry by implementing a new research architecture and technology team.
Requirements
- Expert knowledge of FDA regulations and ICH/GCP guidelines
- Experience with electronic data capture (EDC) systems
- Knowledge of clinical research protocols and procedures
- Experience with data management and quality control activities
- Familiarity with Topography’s proprietary tool set
- Understanding of regulations, policies, and guidelines applicable to clinical research
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
Other
- 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
- Demonstrated track record of delivering clean data and a high-quality patient experience
- Ability to thrive with multiple tasks and independent problem solving
